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New: Chapter Development Highlights (PDF)

Note: Chapters that do not have news provide their contact information.

Chapters are listed alphabetically, by state/country.

Alabama SoCRA Chapter News

Date: Wednesday, January 11, 2012

Time: 12:00 noon - 1:00 pm

Topic: Prescription Drug User Fee Act (PDUFA): It's Impact on Healthcare

Objectives of the presentation are:

  • Review PDUFA history
  • Discuss the impact of PDUFA fees on research
  • Define REMS and drugs that have the FDA mandate for these services
  • Describe potential changes to the PDUFA V act for 2013-2017

Speaker:
Brenda Denson, Pharm.D.
Investigational Pharmacist
The Children's Hospital of Alabama

CEU: One hour CEU credit is offered for this session for SoCRA members

Location:
Children's Harbor Building
Bradley Lecture Center,4th Floor, Fellows Conference Room
1600 6th Avenue South
Birmingham, Alabama 35233

Parking:
5th Avenue Parking Deck, corner of 5th Avenue and 16th Street South
Buzz attendant for entry (mention SoCRA meeting)

Cost: Free admission. All members and non-members welcome

RSVP: Susan Branscum, CCRP at sbranscum@peds.uab.edu or 205-996-7805

Information:

Please share this announcement with your colleagues.

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Arizona (Phoenix) Valley of the Sun SoCRA Chapter News

The Phoenix SoCRA Chapter is a forum for anyone interested or working in clinical research. This year's meetings will be held in February, April, June, October, and December in the Phoenix metropolitan area. One continuing education credit (CEC) is available for SoCRA members for attending the one-hour, clinical research-related presentation given by an invited speaker. Past meeting summaries and selected presentations will be available at subsequent meetings.

MEETING ANNOUNCEMENT

Thursday, February 16, 2012

7:00 - 8:30 PM

Location:
Banner Desert Medical Center
Rosati Education Center - Ocotillo Room
1400 S. Dobson Rd
Mesa AZ 85202

Directions: Enter campus from traffic light on Dobson Rd. Turn Left. Make immediate right turn into Desert Medical Pavilion parking lot. Turn left to enter parking structure. Enter Desert Medical Pavilion at West of structure, Entrance: Rosati Education Center. At entrance, Turn Right, then make left. Enter Conference Room - Ocotillo.

Click here for Map

Speaker: Callie Naholowaa, CCRP

Presentation: Recruitment in Clinical Research

Objectives:

  • Discuss federal regulations and guidelines applicable to recruitment strategies.
  • Review sponsor and site roles in the recruitment process.
  • Examine recruitment strategies, methods and materials.
  • Analyze study scenarios and discuss possible recruitment planning.

CEC Available: 1 Credit for SoCRA Members. Only SoCRA members will receive a certificate of attendance.

Questions:

Contact Bridgette Volosin, Phoenix SoCRA Chapter Chairperson
480-203-1591
bvolosin@gmail.com

Planning to Attend? Please RSVP: bvolosin@gmail.com

Please bring a friend and spread the word!

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Arkansas SoCRA Chapter News

The Arkansas SoCRA Chapter in conjunction with the University of Arkansas for Medical Sciences presents:

"Research Roundtable: INDs - Does My Study Need One?"

Date: December 16, 2011

Time: 12:00 pm - 1:00 pm

Location:
University of Arkansas for Medical Sciences - College of Public Health - Room G228

Names and Titles of Speakers: Carole A. Hamon, Manager - Regulatory Affairs

Speaker's Affiliation: University of Arkansas for Medical Sciences

Objectives:

  • Discuss Different Types of INDs.
  • Difference between Research and the Practice of Medicine.

Directions and Parking Information:
University of Arkansas for Medical Sciences
4301 West Markham Street
Little Rock, AR 72205

  1. From Interstate 630, take the Pine/Cedar Street Exit.
  2. Head north on Pine Street until you reach Markham Street.
  3. Turn left onto Markham Street.
  4. Turn left onto Hooper Drive (Entrance 2) and park in Parking 2 (see link to map). Visitor parking is $1.25 for the first hour, plus $.75 for each additional hour up to a maximum of $7 per day. There is no charge for the first 30 minutes.

www.uamshealth.com/upload/docs/maps/printable_pathways.pdf

*SoCRA members are credited with 2 SoCRA Continuing Education Unit (CEU).

Questions: Please contact Amy Jenkins (501-686-5939; ajjenkins@uams.edu) or Julia Washam (501-686-8572; WashamJuliaK@uams.edu).

RSVP: Please RSVP to Amy Jenkins (501-686-5939; ajjenkins@uams.edu) or Julia Washam (501-686-8572; WashamJuliaK@uams.edu).

 

November 18, 2011: Research Roundtable: Using Devices in Research

Date: November 18, 2011

Time: 12:00 pm - 1:00 pm

Location: University of Arkansas for Medical Sciences - College of Public Health - Room G228

Names and Titles of Speakers: Lyndsey Avery, Regulatory Affairs Specialist

Speakers' Affiliations: University of Arkansas for Medical Sciences

Objectives:

  • Identify a device.
  • Understand the difference between using a device in research and the practice of medicine.
  • Have general knowledge of the types of Investigational Device Exemptions and their requirements.

Directions and Parking Information:
University of Arkansas for Medical Sciences
4301 West Markham Street
Little Rock, AR 72205

  1. From Interstate 630, take the Pine/Cedar Street Exit.
  2. Head north on Pine Street until you reach Markham Street.
  3. Turn left onto Markham Street.
  4. Turn left onto Hooper Drive (Entrance 2) and park in Parking 2 (see link to map). Visitor parking is $1.25 for the first hour, plus $.75 for each additional hour up to a maximum of $7 per day. There is no charge for the first 30 minutes.

www.uamshealth.com/upload/docs/maps/printable_pathways.pdf

*SoCRA members are credited with 2 SoCRA Continuing Education Unit (CEU).

Questions: Please contact Amy Jenkins (501-686-5939; ajjenkins@uams.edu) or Julia Washam (501-686-8572; WashamJuliaK@uams.edu).

RSVP: Please RSVP to Amy Jenkins (501-686-5939; ajjenkins@uams.edu) or Julia Washam (501-686-8572; WashamJuliaK@uams.edu).

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Brazil SoCRA Chapter News

1st Brazil SoCRA Chapter Meeting in conjunction with PharmaDeal

Topic : What to expect on an audit

  • Preparation for an Audit
  • FDA Audit Inspections
  • Corrective & Preventive Actions

SoCRA, The Society of Clinical Research Associates is a non- profit, professional organization.

13.700+ members; 8600+ Certified Clinical Research Professionals "CCRP". SoCRA mission is to provide training, continuing education, and an Internationally recognized cetification program that promotes quality clinical research to protect the welfare of research participants and improve global health SoCRA in conjunction with PharmaDeal and as part of the continuing education program will promote The 1st Brazil SoCRA Chapter Meeting discussing an interesting and important topic for all Clinical Research Professionals.

The meeting is open to all Clinical Research professionals.

Target: Professionals working for global projects from Pharma Industry, Academy, CROs and Clinical Labs. This session will provide 1 CE credit for SoCRA Members.

Date and time: 18/November/2011 At 15:00 to 16:30h

Speaker: Carolyn Rugloski, Project Manager at FairPlay Consultants with more tha 20 years of experience in Clinical research. Over the years she hás dedicated herself to the training of Clinical Research Professionals through SoCRA and other educational organizations.

Local:
Sede do Sindusfarma
Rua Alvorada nº 1280 - Vila Olímpia

Parking: Rua Casa do Ator, 975 e Rua Caetano Velasco S/N (antigo endereço: Rua Casa do Ator, nº 1.110). Mercure Apt The World R. Gomes de Carvalho, 1005 - Vila Olímpia.

Inscrições & Informações: PharmaDeal (11) 3085 2709 / 3085 0933 socra@pharmadeal.com.br. Please confirm your attendance.

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California (Northern CA) SoCRA Chapter News

We are pleased to announce the January 2012 meeting of the Northern California Chapter of SoCRA, the Society of Clinical Research Associates.

Date and Time: Thursday, January 19, 2012, 12:00 -1:00PM

Topic: Using Electronic Data Capture in Clinical Research

Program Objectives: At the conclusion of the program, attendees will be able to:

  • Explain the advantages of Electronic Data Capture (EDC)
  • Describe the role of EDC with regard to the new FDA Draft Guidance for Industry for Oversight of
    Clinical Investigations: A Risk-Based Approach to Monitoring (August 2011)
  • Discuss some potential barriers to EDC

Speaker:
Jules Mitchel, President, Target Health

Place: UC Davis Medical Center, Clinical & Translational Science Center (CTSC), 2921 Stockton Blvd., Sacramento, CA. Rm. 1444. For directions to the, please visit: www.ucdmc.ucdavis.edu/ctsc/directions/

Cost: FREE admission (All members and nonmembers welcome)

Directions: For directions, please visit: www.ucdmc.ucdavis.edu/ctsc/directions/

For more Information: Please contact the following individuals:

Daniel Redline (Chair)
(916) 281-2760
dredline@volcanocorp.com

Denise Owensby (Vice Chair)
(916) 703-9191
denise.owensby@ucdmc.ucdavis.edu

*SoCRA members are credited with 1 SoCRA Continuing Education Unit (CEU).

Please share this meeting announcement with your colleagues.

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California (Orange County) SoCRA Chapter News

Date: November 10, 2011

Time: 5:45-6:45 pm

Topic: Manage Your Professional Development through Informal Learning

"This presentation will include the learning and development essentials to manage your career, recognizing knowledge gaps for CRA's, medical product development process, clinical trials medical device & drug development, and informal learning resources for CRA's."

Speaker:
Rogelio Rodriguez, Master of Science in Engineering
Current Position: Consultant, Learning and Development Strategies
Former Position: Director, Continuing Professional Education, UCI

Location:
University of California Irvine, Main Campus
Irvine, CA 92697
Hewitt Hall, Bldg #843
1st Floor, Conference Room #1042
(Parking fee might be required)

Maps for UC Irvine and the surrounding area can be located at:

www.uci.edu/campusmaps.html or http://today.uci.edu/pdf/UCI_07_map_campus.pdf

FREE Admission (All members and nonmembers are welcome)

More information:

Please contact Chapter Chair, Maribelle Guloy-Sunga, BSMT, CCRP at (323) 271-1330, cell (323) 353-2941 or mgsmedresearch@aol.com

CE: SoCRA members are credited 1 SoCRA Continuing Education Unit.

"There will be a 10-minute post presentation meeting to discuss future programs for the local chapter."

RSVP: Maribelle Guloy-Sunga, Chairperson
(323) 271-1330 or mgsmedresearh@aol.com

"Bottled water, fruit and cookie bars will be served"

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California (San Diego) SoCRA Chapter News

Date: October 26, 2011 Wednesday

Time: 6:00- 7:00 pm

Place:
The Binding Site, Inc.
5889 Oberlin Dr.
San Diego, CA 92121

Speaker:
Bonnie Brookshire, CIP, Senior Director of Compliance, Compass IRB

Topic:
What is an Unanticipated Problem and What Does That Mean for MY SAE?

Objectives:

  • Participants will become familiar with the FDA's Guidance on Unanticipated Problems
  • Participants will learn the changes to SAE and IND reporting

Bonnie Brookshire, CIP is the Senior Director of Compliance for Compass IRB. Her career began at the clinical site level managing regulatory functions for multiple projects at Synergy Clinical Research from 2003 to 2004. Ms. Brookshire transitioned from the clinical site to IRB in 2004. At Compass IRB, Ms. Brookshire has served in both project management and compliance arenas hosting successful Sponsor audits and FDA inspections. At Compass IRB, she led the team to full AAHRPP Accreditation.

One hour CEU credit is offered for attending this session for SoCRA members.

RSVP:
Germaine Schwider
g.schwider@att.net
949-433-4211

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California (San Francisco Bay Area) SoCRA Chapter News

We are pleased to announce the June meeting of the San Francisco Bay Area Chapter of SoCRA, the Society of Clinical Research Associates.

Thursday, June 2, 2011

Topic: FDA Final Rule on IND Safety Reporting: Impact to Your Clinical Studies

BioSoteria President & CEO Sally Van Doren will present a review of the New Rule -- the complex rule on new safety reporting requirements for clinical trials. The FDA announced changes to the regulations on IND safety reporting, which went into effect on March 28, 2011, (although it may not be enforced until end of September 2011).

The new rule requires that certain safety information now be reported within 15 days of becoming aware of an occurrence. These reports include:

  • Findings from clinical studies that suggest a significant risk to study participants
  • Serious suspected adverse reactions that occur at a rate higher than described in the IB; and
  • SAEs from bioavailability and bioequivalence studies

Along with this final rule, the FDA issued a draft guidance for industry and investigators that provides information and advice about the new requirements. Dr. Van Doren will review how these regulatory changes may impact your ongoing and future clinical trials.

Speaker:
Sally Van Doren, PharmD
President & CEO
BioSoteria, Inc.

Date and Time: Thursday, June 2, 2011, 3:30 - 5:00 PM

Place:
UCSF - Mt. Zion campus
1600 Divisadero, B-248
Herbst Auditorium (2nd floor)
San Francisco, CA 94115

Please RSVP: Ilana Hettena, CCRP, hettenai@cc.ucsf.edu

FREE admission - All members* and nonmembers welcome

For directions, please visit www.ucsf.edu/maps/mtzion.html

* SoCRA members are credited with 1 SoCRA Continuing Education Unit (CEU).

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California (Sylmar) SoCRA Chapter News

We are pleased to announce the first kick off meeting for the California (Sylmar) SoCRA Chapter:

Date and Time: Thursday, October 20, 2011 from 12:00-1:00

Meeting Location:
St. Jude Medical
13150 Telfair Avenue
Sylmar, CA 91342
(Please check in with front desk receptionist so you can be escorted to the Telfair Assembly meeting room #33005).

Speaker:
Speaker: Colleen Canan, RAC, CCRA Senior Regulatory Specialist, St. Jude Medical

Presentation Title: FDA - The Changing Regulatory Landscape for Medical Devices

Program Objectives:
This presentation will discuss medical device regulatory trends, developments and recent challenges withinthe U.S. Food and Drug Administration (FDA) landscape. Given recent medical device recalls, FDA is looking for opportunities to revamp device regulatory approval pathways (i.e. 510K). Colleen will review these regulatory pathways and explore potential implications going forward.

CEU: 1 CEU will be issued for SoCRA Members

Cost: FREE admission

All SoCRA members and non-members are welcome

Please contact Bill Gross at wgross@sjm.com or Anuja Kulkarni at akulkarni04@sjm.com to RSVP.

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California (South Bay - LA to San Diego Area) SoCRA Chapter News

From San Diego to Los Angeles…..covering Southern California, the last piece of the puzzle!

YOU ARE INVITED TO THE FIRST MEETING OF: THE SOUTH BAY CHAPTER OF SOCRA!

When: 10-10-2007 @ 4:00 PM

Where: Breastlink Offices/701 E. 28th St./Suite #414/Long Beach, CA 90806

Contact: Mary Suarez @ 562-933-7866 or msuarez@memorialcare.org

Wondered about SoCRA? Who are they? Where are they? What do they do? Would it benefit me to join?

Do they have fabulous desserts at the Long Beach meetings? (YES!).

Members and non-members are welcome.

The topic of discussion will be Recruitment with guest speakers:

Joetta Wallace MSN, RN, FNPC
Miller’s Children Hospital

Alicia Martin-Santiago/Research Inquiry Coordinator
Chao Family Comprehensive Cancer Center @ University of California, Irvine

Tarek Dessouky, M.D.,DIS, MBA, MPH
Director of American Institute of Research

Looking forward to meeting you all!

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California (Ventura County) SoCRA Chapter News

Date: Monday, June 27, 2011

Time: 6:00- 7:00 pm

Place:
Westlake Village City Hall
31200 Oak Crest Drive
Westlake Village, California 91361
Phone: 818.706.1613

Speaker: Jamuna Ramnath, Ph.D.

Topic: Latest Developments in Personalized Medical Research

Summary:

Jamuna Ramnath is a technical scientist in a global biotechnology company and a leader in sample preparation and assay detection technologies. Jamuna has a doctorate in molecular biology with over 20 years of broad research and corporate experience in the biotechnology industry. Prior to joining the biotechnology industry, her research experience spanned from her doctoral thesis to postdoctoral research at the University of Strathclyde, Glasgow, and Norris Comprehensive Cancer Center at the University of Southern California. She has participated in numerous conferences and has received the Young Scientist Aflac Award in Cancer Research (AACR) for her research at the University of Southern California.

During this presentation, Jamuna will discuss the latest developments of personalized medical research, and how companion diagnostics, a relatively new concept which is emerging in drug discovery and development, is promising to change the way drugs are made and marketed. This presentation will provide insight for integrating personalized medical research into clinical practice to create a value-based, patient-centric health care system for improved efficacy and outcomes.

CE: One hour continuing education credit (CEU) credit is offered to SoCRA members for attending this session.

RSVP:
Ana Sharma, MPH, RQAP-GCP, CCRP
ana.sharma@gmail.com
617 913 0642

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Colorado SoCRA Chapter News

The Colorado Chapter is pleased to announce a Supplemental Education Meeting held in conjunction with the Clinical Investigations Core of the University of Colorado. This meeting will be held at the Anschutz Campus.

Date: April 26th, 2011

Time: 12-1pm. Please bring your own lunch.

Location:
University of Colorado Anschutz Medical Campus
Building- Anschutz Cancer Pavilion, Room 3052

Names of speakers:

  • Alison Sutton, RN, BSN, CCRP
  • Sarah Eppers, RN, BSN, OCN, CCRP

Title: Getting Serious about AE and SAE Reporting

Alison and Sarah will outline the definition of Serious Adverse Events and Adverse Events. They will also present on the guidelines for reporting SAEs and AEs.

Directions and parking information: The campus is located at 1665 Aurora Court, Aurora, CO
Please park in the VISITOR LOT designated on the campus. Please visit our website for further directions: www.ucdenver.edu/admissions/tours/Pages/AnschutzMedicalCampus.aspx

For additional information please contact Sherri Wilke, sherri.wilke@ucdenver.edu with any questions.

Area map and Fitzsimons campus map

Area Map

Fitzsimons Campus Map

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Connecticut SoCRA Chapter News 

We are pleased to announce another educational seminar hosted by the Connecticut Chapter of the Society of Clinical Research Associates (SoCRA):

Date: Tuesday May 24, 2011

  • 5:30pm Registration and Dinner provided
  • 6:00pm Presentation and Discussion

Location:
Middlesex Hospital Cancer Center, 2nd floor
Conference room A/B
540 Saybrook Road
Middletown, CT 06457

Seminar Theme: Older Adult Sensitivity Training - Understanding and Working Effectively with the Older [Cancer] Patient

Presented by:
Vicki L. Schmall, PhD
Executive Director, Gerontology and Training Specialist, Aging Concerns, West Linn, OR

Brief Description:
Through experiential activities, participants will "step into the shoes" of older adults and learn about the impact aging-related changes-loss of vision, hearing loss, normal changes in memory versus dementia, etc.-can have on older adults and the implications of these changes for communicating with and working more effectively with older patients.

This session will answer such questions as: Why does an older person respond to a question with something totally unrelated to what was asked? What does the world look like to a person who has cataracts, glaucoma, macular degeneration, or other changes in visions? How are normal changes in learning and memory different from those associated with Alzheimer's disease, and what are the implications for both? Ms. Schmall will discuss enrollment of older adults into clinical trials and the appropriate sensitivity that research professionals should have toward older adults as they enroll and participate in clinical trials.

Learning Objectives:

  • Identify the need for and significance of sensitivity skills in working with older adults in healthcare settings.
  • Describe age-related changes that can present challenges incommunication with older adults.
  • Describe communication techniques to partner more effectively with older adults in healthcare settings.

Please RSVP by May 17 to Susanne Morrill, CCRP: smorril@harthosp.org; For more information contact Susanne at 860 545-1588.

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Florida (South) SoCRA Chapter News

Date: September 16, 2011

Time: 2:00 to 4:00 pm

Location:
Holy Cross Hospital
SICC Conference Room B
4725 North Federal Highway
Fort Lauderdale, FL 33308

Speaker:
Jorge Adames, PA, RN, BSN
Michael & Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital

Topic:
"Quality and Safety in Cancer Clinical Trials"

  • Review basic concepts of Quality and Safety in relation to cancer clinical trials
  • Review basics of Quality Appraisal
  • Review few examples of Quality within the context of daily practice
  • Review basics of AE reporting and CTCAE
  • Present NCI study on PRO-CTCAE

Speaker:
Luke Beeler, Pharm. D., Investigational Pharmacist
Michael & Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital

Topic:
"The Role of Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics in Clinical Research and Drug Development"

  • Define basic pharmacokinetic (PK) terms.
  • Explain pharmacokinetic concepts for drugs.
  • Explain pharmacodynamics (PD) in terms of how a drug exerts its effects.
  • Understand howpharmacogenetics (PG) play a role in the effects of a drug.
  • Demonstrate how PK-PD and PG are interrelated.
  • Relate these pharmacology concepts to drug development and research

RSVP: Lorraine.hickson@holy-cross.com

Parking: Parking available at main hospital

CE: 2 CEU's available for SoCRA members

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Florida/Suncoast SoCRA Chapter News 

Title of Program: "Developing Grants for Clinical Research: Are you ready for 2012?"

Date: Thursday, December 8, 2011

Time: 6:00 to 8:00 pm

Location:
H. Lee Moffitt Cancer Center and Research Institute
Stabile Research Building
Ferman Family Conference Room, 1st Floor
12901 Magnolia Drive
Tampa, Florida 33612

Speaker:
Debra A. Mimo, RN, CRC, CCRP
Clinical Research Nurse II, Phase I Clinical Trials
H. Lee Moffitt Cancer Center and Research Institute
Florida Chapter Chairperson,
Society of Clinical Research Professionals (SoCRA)

Grant application deadlines are coming up soon in February, April and May 2012. Are you ready? What types of research and research programs are priorities of funding organizations in 2012? Do you know? This presentation will help you be ready.

Who Should Attend?
Investigators, Fellows, Medical and Nursing Students, Research Administrators, and others who are or will be responsible for writing, submitting, and/or conducting clinical research.

Goals of Program:

  • Describe a successful format for organizing a competitive grant application
  • Discuss the required components of a grant
  • How to determine what funding organizations deem "priority" and "Fields of Interest" (FOI's)
  • Provide insight into the grant review process
  • Describe techniques and tips for reviewers and writers
  • Identify trends and future developments: "omics", new drug "pipelines", external partnerships, global partnering

Seating and parking is limited. Please RSVP for this Program by contacting the SoCRA Florida Chapter Chairperson at dmimo2000@aol.com. Chapter meeting to follow educational session.

There will be 1 (one) CE provided to SoCRA members for this Program.

For Directions and Map information please visit: www.moffitt.org/site.aspx?spid=36454F19B1044B38808E35ADD1DFF832.

Parking: Parking is complimentary for this event from 6:00 to 8:00 pm. Pull up to the Gold Valet Parking for the Stabile Research Building. If you are a Moffitt or USF employee please use your employee designated parking space.

Note: Mark your calendars for February. The FDA Florida Field Office will be our Guest Speaker!!! Announcement forthcoming.

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Georgia SoCRA Chapter News 

Saturday, January 15, 2011

Place:
Cross Creek Cafe
1221 Cross Creek Parkway NW
Atlanta, GA30327
(404) 351-1550

Agenda:

  • Welcome & Introductions: 10:00 -10:15
  • Presentation Time: 10:15-11:30 (1 hr. presentation time and 15 minutes for Q&A)
  • Networking: 11:30-12:00

Speaker:
Robert A. Paarlberg/Regulatory Affairs Specialist
Principal Paarlberg & Associates, LLC

Topic: Clinical Trial Disclosure

Learning Objectives:

  • Describe the elements of clinical trial disclosure
  • Identify company processes impacted by global clinical trial disclosure requirements
  • Understand the consequences of non-compliance
  • Recognize the impact of rule-making by NIH on expanding the ClinicalTrials.gov database

1.25 SoCRA approved CE credits available

Please Note: A fee of $10.00 will be collected from each attendee by the facility to cover the cost of brunch and room rental.

Please RSVP by January 12, 2011 at gasocrainfo@yahoo.com or 877-847-2186

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Great Lakes SoCRA Chapter News - Michigan/Ohio/Wisconsin

Chapter Chairperson:
Monica Stiddom
Education Coordinator, Michigan Institute for Clinical and Health Research (MICHR)
Program Administrator, Multidisciplinary Clinical Researchers in Training Program (MCRiT)
University of Michigan
24 Frank Lloyd Wright Drive, Lobby M
Ann Arbor, MI 48109-0738
(734) 998-7348
(734) 998-7228 Fax
mhealy@umich.edu
www.med.umich.edu/cacr
www.med.umich.edu/cacr/mcrit
www.clinicalresearchresources.net

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Halifax, Nova Scotia, Canada SoCRA Chapter News

The Halifax Chapter of SoCRA presents: "Regulatory Requirements for Research: Drugs, Devices and Natural Health Products"

April 19, 2011 - 1200 to 1315 PM

Royal Bank Theater
Halifax Infirmary
1796 Summer St.
Halifax, Nova Scotia

Guest Speaker:
Janet Gallant RN BScN
Manager, Research Education Program
Research Services, Capital District Health Authority
Halifax, Nova Scotia

Objectives:

At the completion of this session, participants will be able to:

  • Identify the various regulations which may apply to research
  • Match various types of research products to applicable regulations
  • Recognize the implications of compliance for investigator-initiated research

1 hour of CEU credit is offered to SoCRA members for attending this session.

Please rsvp to:
Janet Gallant RN BScN CCRP
Chair, Halifax SoCRA Chapter
Program Manager, Research Education
Capital District Health Authority
Halifax, Nova Scotia
janet.gallant@cdha.nshealth.ca
902-473-2118

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Illinois/Indiana/Kentucky/Ohio (Crossroads) Chapter News

The Crossroads Chapter of SoCRA presents: CRF Design: CRF Wording & Query Free CRF

Objectives:

  • To ensure understanding of CRF data being collected.
  • To promote good CRF design practices to improve data quality.
  • To increase knowledge of CRF purpose/style to promote better data collection to reduce needed queries.

Presented by:
Erika Horan
Principal Clinical Data Manager
i3 Statprobe

Date: Thursday, September 01, 2011

Agenda:
5:30 pm Check-in
6:00-7:15 pm Meeting

Place:
Farm Bureau Building
225 South East Street, Suite 200
Indianapolis, IN 46202

Parking:
Parking is available in the Farm Bureau parking garage. There are entrances from both East Georgia Street and East Louisiana Street. At the parking garage gate, you will need to buzz security to be let in.

Cost: Attendance is free and open to SoCRA and non-SoCRA members.

CE: This program has been awarded 1.0 Continuing Education Unit (CEU).

If you plan to attend and would like a CEU certificate, please contact Cynthia Partridge-Bunin at cynthia.partridgebunin@gmail.com.

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Indiana (South) SoCRA Chapter News

The Southern Indiana Chapter of SoCRA presents: "What We Can Learn from FDA Warning Letters"

Presented by:
David Finch, CCRP
Sr. Clinical Site Manager/Sr. CRA III
Quintiles Inc.

July 18, 2011

  • 5:30 pm Check-in
  • 6:00-7:30 pm Meeting

Place:

Floyd Memorial Hospital and Health Services
1850 State Street
New Albany, IN 47167
Education Department

Please RSVP to:

Joslin Diabetes Research
812 981-6684

This program has been awarded 1.5 Continuing Education Unit(CEU) for SoCRA Members.

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Kingston, Ontario Canada SoCRA Chapter News

The Kingston SoCRA Chapter in conjunction with the KGH Clinical Research Associates Advisory Committee & Queen's University's Financial Services Department Proudly presents:

"Research Financing 101 - Understanding and Interpreting Queen's University Research Reports".

Presenters:

  • Diann Andrews (Research Accounting Administrator, Queen's University)
  • Louisa Jennings (Research Accounting Manager, Queen's University)
  • Joe Le Blanc (Research Accounting Manager, Queen's University)

Objectives:

  • To help understand the research accounting practices at Queen's University;
  • To learn how to set up/close research accounts, interpret research reports, and carry out research transactions; and
  • To address any research financial project management inquires.

Date: Friday, February 17th, 2012

Time: 9:00 AM-12:00 PM

Location: Richardson Labs Amphitheatre (Room 104), Queen's University (located near Etherington Hall /underground parking tunnel)

Agenda:

Welcome and Introductions: 9:00-9:05 am

Q&A Period: 12:00 pm -12:15 pm

Module 1: Reading Research Reports

  • Commitments
  • Revenue, detail and summary section

Module 2: Research Transactions- Journal Entries

  • Chart of Accounts
  • Cheque Requisitions
  • Overhead
  • Travel claims

Module 3: Research 101

  • Types of grants
  • Project set up
  • Signing authority
  • Open/close projects
  • Approval of financial reports
  • Audits

Presentation Time: 9:05 pm-12:00 pm

Q&A Period: 12:00 pm -12:15 pm

RSVP:

SoCRA Chairperson
Janet Clark-Pereira
Jmc2@queensu.ca or 613-548-7805

Veronica Harris-McAllister
harrismv@kgh.kari.net
613-549-6666, ext 3653

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Maine SoCRA Chapter News

The State of Maine SoCRA Chapter will have a meeting on January 24, 2008 at 2PM.

The presentation will be “Adverse Event Reporting using the CTCAE Version 3.0”.

The meeting will be held at Acadia Clinical Research, 304 Hancock St, Bangor, ME, Suite # 2J

Members planning to attend should RSVP:
Ms. Gail Baillargeon, CCRP
E-mail: gail@acadiaclinical.com
Phone (207) 941-9965

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Maryland SoCRA Chapter News

This Chapter targets all clinical research professionals. We strive to be in-depth and educational and to offer opportunities for greater understanding of the full clinical research process -- from the nascent steps in the laboratory to the operations of sponsors, CROs, NIH, sites, the business office, and finally onto market approval and post-market studies.

Date: Monday, January 24, 2011 No Cost

Doors open: 5:30 p.m.

Presentation: 6:00 p.m. - 7:00 p.m. (one hour of CE)

Speaker: Karen Ball, BSN, MS, RN, CCRP, International Regulatory Affairs Specialist, Center for Vaccine Development, University of Maryland

Topic: Informed Consent in Developing Countries: Is there a literate witness in the house?

  • Required elements of informed consent
  • Challenges of consenting with language barriers and illiteracy
  • Cultural considerations in the consenting process
  • Class participation - real life problem and resolution case scenario

Location:
Enoch Pratt Free Library
1251 Light Street
Baltimore, MD 21230
(in Federal Hill)

Parking: There is parking on the street and one block away in a public garage.

SoCRA CEU Credit: 1.0 hour of CE is available for SoCRA members.
Certificates of attendance will be provided.

RSVP: Anne N. Martien, MBA, CCRP, CRCP
Chapter Chairperson
E-mail: MDSocra@yahoo.com
Cell: 443-603-4478

Seating: The library conference room seats 80.

Registrar Request: An amiable SOCRA member willing to help attendees sign in would be greatly appreciated. Should you wish to help in this way, please contact Anne Martien.

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Massachusetts SoCRA Chapter News

Date: Monday, December 5, 2011

Time: 5:00pm- 6:00pm

Location:
Tufts University School of Dental Medicine
Rachel's Amphitheater (room 1414)
One Kneeland Street
Boston, MA 02111

Speaker: Adèle D. Audet, R.Ph., Assistant Director, Drug Control Program

Speaker Affiliation: MA Department of Public Health

Topic: Researcher Application 101

Objectives:

  • This presentation by a representative of the MDPH will focus on the MA Controlled Substances Registration (MCSR) for research.
  • Learn about the process for registration and how you might better prepare and submit applications to make the process smoother and easier for everyone.

Credits: Participants may claim up to one hour of SoCRA CEU (members may only claim actual time spent in the educational event). Certificates of attendance will be available at the completion of the event.

Questions: Please contact, Alyssa K. (DellaCroce) Gateman, MPH CCRP 617-632-3731or agateman@partners.org.

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Michigan - Saginaw Bay Chapter News

The Saginaw Bay Chapter of SoCRA is holding a meeting in conjunction with the IOMSN meeting is Saginaw on April 25th, 1PM to 2PM.

Featured Speaker Topic:
Benjamin M. Segal, M.D.
Holtom-Garrett Professor of Neurology
Director, Multiple Sclerosis Program
Universityof Michigan

Featured Topic:
Research updates in Multiple Sclerosis

Location:
Masude lecture theater St Mary’s Of Michigan Health Education Center
800 S. Washington Ave. Saginaw MI 48601

Contact information and R.S.V.P.
Heather Clark (989) 497-3023

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Minnesota North Central Regional (Minnesota) SoCRA Chapter News

Location:
Heillicher auditorium
Park Avenue Medical Office Building
710 East 24th Street
Minneapolis, MN 55404

Date and Time:
Wednesday, May 25
5:30pm - 6:00pm - networking
6:00pm 0in - Presentation

Presenter:
Linda Knowlton, CCRP
Assistant Project Manager/Lead Audit Coordinator
Coalition of Cancer Cooperative Groups

Title: Auditing - An Exchange of Information

Learning Objectives: At the end of this presentation, attendees should know and understand:

  • An overview of the audit process
  • Useful auditing tips
  • Audit guidelines to follow

Continuing Education Credits: 1 CE Credit for SoCRA members.

Fee: This program is free of charge to all.

Please RSVP to:
Lindsey Fallenstein
Phone: 952-567-6060
Email: lrfallenstein@mneye.com

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Minnesota Southeast (SEMN) SoCRA Chapter News (MN/WI/IA)

The SEMN SoCRA Chapter Meeting on Tuesday, October 4, 2011

  1. 5:15 - 5:30 pm Gathering/Networking
  2. 5:30 - 6:30 pm Janet Olson, Ph.D.

Presenter: Jody Morrisette, CCRP

Title: The Mayo Clinic Biobank

Objectives:

  1. Define the OHRP Guidance regarding biorepositories
  2. Describe the consenting process of the Mayo Clinic Biobank
  3. Describe the Governance and Usage of the Mayo Clinic Biobank.

CE: 1 CEU will be offered for this presentation for SoCRA Members.

Location of lectures:

Mayo Clinic Campus, CTSA Classroom 325a, 3rd Floor of the Plummer Building

Parking is available in City ramps

No RSVP required

Inquiries can be directed to:

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Iowa/Nebraska/South Dakota (Central Plains) SoCRA Chapter News

The SoCRA Central Plains Area Chapter presents a SoCRA Educational Opportunity

When: Wednesday, December 21, 12:00-1:00

Host site:
Palmer Research Center
Davenport, Iowa

Teleconferencing available upon request. Limited lines available so RSVP - 5 days in advance.

Please have your site liaison contact Jen Kucera to reserve your telephone connection: jikucera@unmc.edu

Contact your site liaison for site specific meeting room/location.

Guest Speaker:
Rebecca Rice
Study Coordinator for the Palmer Research Clinic in Davenport, Iowa

Title: Fundamental Aspects of Informed Consent

Objectives: The participant will gain a better understanding of three basic elements of the Informed Consent:

  • Voluntarism
  • Comprehension (written in layman's terms)
  • Disclosure of alternative treatments/procedures

Members and non-members welcome.

This activity has been planned and implemented in accordance with the Society of Clinical Research Associates.

This educational activity received no commercial support.

SoCRA has approved this program for 1 continuing education contact hour for SoCRA members.

Please share this announcement with your colleagues.

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New Mexico SoCRA Chapter News

Date: Wed., Jan. 11, 2012

Time: 6-7:00pm

Location:
Gibson Medical Center
(Formerly Lovelace Medical Center-Gibson Campus)
West Classroom, Education Building
5400 Gibson Blvd SE, Albuquerque, NM 87108

Guest Lecturer:
Kristine Tollestrup, PhD, MPH
Associate Professor/Director, Master of Public Health Program
Department of Family and Community Medicine, School of Medicine
University of New Mexico, Albuquerque, NM

Topic: Obtaining Informed Consent for the National Children's Study

Program Description:
The National Children's Study is a large national study that will examine the effects of the environment on the growth, development, and health of children across the United States, following them from before birth until age 21 years. The overall goal of the study is to improve the health and well-being of children and contribute to understanding the role various factors have on their health and disease. The environmental factors which will be examined in the study include air, water, diet, sound, family dynamics, community and cultural influences, and genetics. Valencia County is one of 37 study sites that have recently completed a pilot phase to enroll over 100 pregnant women in the study. As part of this pilot phase, we gathered information from focus groups and questionnaires to examine the attitudes, beliefs and concerns of Hispanic and non-Hispanic mothers (ages 18-44) towards genetic/genomic testing for them and their children and maintaining bio-repositories of their genetic material (such as proposed in the NCS). We also gathered information on how their attitudes, beliefs, and concerns influence study participation decisions. We will examine these results and discuss the implications for obtaining informed consent in epidemiologic studies with very long-term follow-up.

Objectives:

  • To identify and discuss the major attitudes, beliefs and concerns of pregnant women associated with participating in a long-term epidemiologic study of their children.
  • To discuss the barriers to obtaining informed consent from pregnant women for a long-term epidemiologic study of themselves and their children.
  • To identify methods to improve participation and consent rates of pregnant women for very long-term epidemiologic studies.

Join the speaker for a brown bag dinner @ 5:30pm

One hour of SoCRA Continuing Education Credit is available.

See directions below.

Mark your calendars for the 2012 Chapter Meetings

  • Wed., Jan. 11, 2012
  • Wed., April 11, 2012
  • Wed., July 11, 2012
  • Wed., Oct. 10, 2012

Directions:

Approaching from the west of the Gibson Medical Center (formerly Lovelace Medical Center) or from I-25: Exit on Gibson Blvd East. Travel approximately 2 ½ miles. After passing San Mateo drive to the east side of the campus to the light at Valencia. Turn right into the parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the Education Building; the West Classroom is to the left of the auditorium.

Approaching from the east of the Gibson Medical Center (formerly Lovelace Medical Center): from the intersection of San Pedro and Gibson, travel west approximately 2 blocks to the light at Valencia. Turn left into the parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the Education Building; the West Classroom is to the left of the auditorium.

Contact:
Ann Von Worley, RN, BSHS, CCRP
Research Associate, LCF Research
2309 Renard Pl SE Suite 103
Albuquerque, NM 87106
505-262-7569
ann.vonworley@LCFresearch.org

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New York Hudson Valley SoCRA Chapter News

New York Hudson Valley SoCRA Chapter, Southern New York/New Jersey presents "The Clinical Research Seminar Series"

We are pleased to announce the following dates for the end of 2011 and beginning of 2012 for the "New York Hudson Valley SoCRA" chapter meetings and presentations:

  • January 13, 2012 - 12pm-1pm Presentation at Vassar Brothers Medical Center, Joseph Tower Auditorium followed by SoCRA Chapter Meeting and "Optional" Networking Luncheon "Shadows on the Hudson" Restaurant in Poughkeepsie, NY
  • February 16, 2012 - 5 pm -8 pm Presentation on "Clinical Trials" by Janet Ellen Holwell, CCRC, CCRA President of the NY Metropolitan Chapter of ACRP. The session will begin with Chapter Meeting plus Networking Dinner Sharing Career Opportunities in Clinical Research Discussion of SoCRA 2012 events; location will be in Manhattan on 3rd Avenue near 47th Street in proximity to Grand Central Terminal (NYC)
  • March 12, 2012- 6:30pm-8:30pm Chapter Meeting and Presentation on SOPs and Clinical Research by Ingrid Gherson, BS, CCRP, MPH Clinical Research Coordinator at New York Medical College, Division of Pediatric Pulmonology location will be at School of Health Science and Practice, campus adjoining Westchester County Medical Center, Valhalla, New York (Westchester County).
  • April 6, 2012 - SoCRA CCRP Exam at New York Hospital Queens (NYHQ) - exam time: from 9 am - 1pm in Flushing, Queens, NY. There will also be a Chapter Meeting and Presentation beginning at 5 pm at Vassar Brothers Medical Center, Joseph Tower Auditorium followed by "Optional" Networking and CCRP Certification Exam Celebratory Dinner at "Shadows on the Hudson" Restaurant location in Poughkeepsie, NY (Dutchess County)
  • May 18, 2012- 12pm-1pm Presentation at Vassar Brothers Medical Center, Joseph Tower Auditorium followed by SoCRA Chapter Meeting and "Optional" Networking Luncheon at "Shadows on the Hudson," Restaurant location in Poughkeepsie, NY (Dutchess County)

Friday, January 13, 2012 - NY Hudson Valley SoCRA Chapter Meeting Presentation Topic & Schedule:
12 pm - 1 pm

SoCRA Chapter Presentation Given by Guest Speaker:

Steven Lascher, DVM, MPH, PhD: VP, Executive Director of Research, Office of Research and Analytics, Vassar Brothers Medical Center (VBMC), Health Quest Hospital System Affiliate

Title of Presentation: Seminar Discussion Part 2: "Is this Clinical Study Ethical? A Discussion of 'Equipoise' from Differing Perspectives."

Topic: Building on the previous discussion, Dr. Lascher will introduce the concept of 'equipoise' and its implications for clinical research.

About Dr. Steven Lascher:

Steven Lascher, DVM, MPH, PhD, the Vice President and Executive Director of the Office of Research and Analytics at Vassar Brothers Medical Center and an expert in designing and building comprehensive research programs for organizations, is developing the Office of Research and Analytics at Vassar Brothers Medical Center, a high quality community hospital fast becoming the Mid-Hudson Valley's (NY) regional referral center. Previously, Dr. Lascher founded the Office of Research and Clinical Trials at St. Vincent Catholic Medical Centers of New York. After completing a DHHS Epidemiology Training Fellowship, he became the American College of Physicians' Clinical Epidemiologist, serving as methodologist for the organization's evidence-based clinical practice guideline development program. After practicing equine medicine for 15 years, he earned an MPH in epidemiology and biostatistics and a PhD in health services research, and completed a post-doc in outcomes research, all at Johns Hopkins Bloomberg School of Public Health. His dissertation focused on physician conformance with clinical practice guidelines. Dr. Lascher, a member of the Delta Omega Public Health Honor Society, has been a faculty member of Johns Hopkins and New York Medical College. He volunteers at Johns Hopkins University where he serves on the Executive Committee of the 170,000 member alumni association.

Accreditation "Continuing Education" for Participation in Dr. Lascher's 1-hour Presentation - 1 CEU = 1 Contact Hour. The NY Hudson Valley Chapter offers Continuing Education (1-CEU) for SoCRA members who attend this Presentation. Continuing Education Credit will be assigned commensurate with the extent of Attendee's participation in this activity. Attendance will be recorded and a "Certificate of Attendance" will be distributed for SoCRA Members only.

Location of January 13th Presentation: Vassar Brothers Medical Center in the Joseph Tower Auditorium, Poughkeepsie, New York - *** This Poughkeepsie location is easily accessible by train, plane, bus, and car from the Hudson Valley Region, Upstate New York, Albany and from the 5 boroughs of New York City (Bronx, Brooklyn, Manhattan, Staten Island and Queens) and in close proximity for travel from New Jersey and Connecticut.

Address for Presentation: Vassar Brothers Medical Center, Health Quest Hospital Affiliate, 45 Reade Place, Poughkeepsie, New York 12601 - Presentation will be held in the Joseph Tower Auditorium, the building adjacent to hospital and next to Dyson Center for Cancer Care. Poughkeepsie, NY is located halfway between New York City and Albany, New York and close to New Jersey and Connecticut (see directions below).

Cost: "FreeAdmission" to the Presentation (open to all SoCRA Members, Non-members, all Medical and Research Professionals).

Must RSVP: admin@howard-centuryclinicalresearch.com or 914-573-1710

When arriving for the presentation at Vassar Brothers Medical Center, please go directly to the Joseph Tower Auditorium in the Joseph Tower Building or for assistance contact Grace Kim, Research Compliance Manager, Office of Research and Analytics at Vassar Brothers Medical Center, Joseph Tower: 845-483-6323 or gkim@Health-quest.org

*** This chapter presentation is open to all medical and clinical research professionals, especially targeting professionals located in the Hudson Valley Region of Dutchess, Ulster, Sullivan, Orange, Westchester, Rockland, and Putnam Counties and the Southern region of New York ("Manhattan, the Bronx, Queens, Brooklyn and Staten Island") and anyone in our neighboring states, New Jersey and Connecticut.

New York Hudson Valley SoCRA Chapter meeting begins immediately after the conclusion of the Presentation. We will meet at "Shadows on the Hudson," 176 Rinaldi Boulevard, Lounge area of the restaurant, and then we will be seated for the "optional" Lunch (see directions below.)This restaurant location is in proximity to Vassar Brothers Medical Center. After the presentation, we will travel a short distance from the Medical Center to the restaurant "Shadows on the Hudson" restaurant. Discussion on chapter activities, future chapter meetings, networking opportunities, sharing career opportunities in Clinical Research, SoCRA CCRP Certification Exam at New York Hospital Queens on April 6, 2012 and Study Groups for the CCRP and SoCRA National events.

"Optional" Networking Luncheon - "Cost of Lunch Paid by Attendee" - will take place after Dr. Lascher's presentation : at "Shadows on the Hudson" (in proximity to Vassar Brothers Medical Center) 176 Rinaldi Boulevard, Poughkeepsie, NY 12601 (see directions below.) Must contact Crystal to RSVP. Please call or e-mail to confirm attendance at lunch: 914-573-1710 or admin@howard-centuryclinicalresearch.com). If attending Lunch: Reservation under the name "Century"
*** Note: Lunch is optional: "at the attendee's expense"

Directions to "Vassar Brothers Medical Center" and "Shadows on the Hudson:"

Vassar Brothers Medical Center, Affiliate Health Quest Hospital Systems:
45 Reade Place, Poughkeepsie, NY - Presentation will be held in the "Joseph Tower Auditorium" in the Joseph Tower Building www.health-quest.org (Vassar Brothers Medical Center is located in proximity to the Metro North/Amtrak "Poughkeepsie" Train Station)

Shadows on the Hudson - Restaurant:
176 Rinaldi Boulevard, Poughkeepsie, New York 12601. Meet in Lounge of Restaurant for an abbreviated SoCRA Chapter Meeting and then participate in an "Optional" Networking Luncheon: www.shadowsonthehudson.com Shadows on the Hudson (845-486-9500) is near Route 9/Columbia Street in Poughkeepsie. This waterfront restaurant, perched on a cliff 40 feet above the Hudson River, with views of the Mid-Hudson Bridge, has an affordable menu with a focus on Seafood and Steaks. (Located in proximity to Vassar Brothers Medical Center and the Metro North Train/Amtrak "Poughkeepsie" Station)

Transportation:

By Plane: Stewart International Airport in Newburgh, New York or Dutchess County Airport.

By Train: Metro-North Train "Hudson Line" to Poughkeepsie, New York. Frequent trains from local stops along the Hudson River or from Grand Central Terminal to Poughkeepsie (weekday train from Grand Central leaves about 9:40 am and train arrives in Poughkeepsie approximately 11:21 am). Train runs from NYC about every 30 to 45 minutes. During the afternoon, the train from Poughkeepsie runs approximately every 40 minutes and runs along the Hudson River for local Putnam County, Westchester County and Bronx stops to Manhattan, New York City and there are also Express Trains (Grand Central Terminal). For more information on train schedules and fares, contact: 212-532-4900 or www.mta.info.

By Bus: There is Bus station in New Paltz, NY, and taxis are available a short distance from the bus station to Poughkeepsie. Regular Buses travel from the Port Authority in Manhattan and also from White Plains, Long Island, New Rochelle, Queens, Albany and other Cities to New Paltz, NY- contact: www.trailwaysny.com or call: 800-776-7548

By Taxi: There is a taxi stand in front of the train station. The "Vassar Brothers Medical Center" and "Shadows on the Hudson" are in proximity to the Metro North/Amtrak Poughkeepsie Train Station.

By Amtrak and Long Island Railroad: Travel from Upstate New York, through Albany via Amtrak and those in Long Island, Queens, Brooklyn can take the Long Island Railroad (LIRR) and then the Amtrak to the "Poughkeepsie Station" (or continue travel by Metro-North). Contact Amtrak: 800-872-7245 or www.amtrak.com.

By Car: for travel directions from Albany, New York City, the Hudson Valley, New Jersey or Connecticut, please go to the Vassar Brothers Medical Center website www.heatlh-quest.org or see the "Shadows on the Hudson" website directions www.shadowsonthehudson.com

Parking: There is parking on the street (pay by meter) around the hospital: A Parking Garage and Valet Parking at the hospital.

The Restaurant has free parking onsite for Patrons.

RSVP: Crystal Howard-Century, BS, MA, MS, ABD, EdD (candidate)
SoCRA Chapter Co-Chairperson, NY Hudson Valley SoCRA
E-mail: admin@howard-centuryclinicalresearch.com
Phone: 914-573-1710

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New York State SoCRA Chapter News

SoCRA New York State Chapter is proud to present: Spring Education Program

Friday, April 8, 2011

Welch Allyn Lodge, 4355 State Street Rd., Skaneateles Falls, NY

RSVP: Kathi Durdon (durdonk@welchallyn.com, 315-685-2637)

Agenda:

9:00 - 9:15 a.m. Welcome and Introduction

9:15 - 10:15 a.m. "Functional Service Provider Outsourcing for Clinical Trials"
Philip Baker, Director, Business Development Clinical & Medical, DOCS Global, Inc - ICON Resourcing Solutions

Functional Service Provider (FSP) model has become a focused practice within the pharmaceutical industries as companies attempt to increase efficiencies and quality while reducing cost and timelines. Still there are companies that still struggle with the selection, implementation and execution of a FSP. Here I attempt to outline the benefits and pitfalls when engaging or considering a FSP.

10:15 - 11:15 a.m. "Biostatistics in Protocol Development"
Jiejing Qiu, Biostatistician, Welch Allyn

Every well designed clinical study needs a well designed protocol, it is a written document and agreement between the sponsor, the investigator, the clinical sites, the participants and other related parties. This topic will describe the essential statistical elements required for a study protocol, introduce some of the fundamental statistical concepts, and focus on the biostatisitican 's role and responsibility for a clinical study.

11:15 - 11:30 a.m. Break - 15 minutes

11:30 - 12:00 p.m. "Why Intended User Input is so Important in Device Design/Usability Testing"
Kathi Durdon, MA, CCRP, Welch Allyn

Device design must promote normal use and mitigate potential critical misuse. Intended users are more often than not the nurse and nurse assistant who uses these diagnostic devices in a clinical environment with their patients. Conducting Usability Testing throughout the product development life cycle with intended users is critical to promotion of safe and effective products.

12:00 - 1:00 p.m. Lunch

1:00 - 2:00 p.m. "Innovation is Hard.....What Makes the Juice Worth the Squeeze?"
Robert J. Corona, DO, Chief Medical Officer, Welch Allyn

To innovate well is really tough. Many ideas are brought forward as innovation but a successful innovation passes the so what and who cares test. We will explore all the variables that make up valuable innovations from human factors/usability, patient safety issues to the topic of how safe is safe.

2:00 - 3:00 p.m. "Diabetes Education Research"
Paula M. Trief, Ph.D., Senior Associate Dean for Faculty Affairs & Faculty
Development, Professor, Depts. of Psychiatry & Medicine, SUNY Upstate Medical University, Syracuse, NY

Research indicates that successful behavior change that is required to manage diseases like diabetes is more likely to occur if the patient has good sources of social support from family and partners. Since partners do make a difference, we believed that it was time to design an intervention that ensures that their impact is positive and sustained. We will describe the background, design and implementation of a couples focused diabetes intervention that is currently being studied.

3:00 - 3:15 p.m. Break - 15 minutes

3:15 - 4:15 p.m. "Site Strategies for Survival During this Economic Flux in our Industry"
Debra Gabrielson, Chief Executive Officer, Regional Clinical Research, Inc.

The global economic crisis has affected the pharmaceutical research business. Investigative sites are not immune to the turmoil. There are fewer studies, more competition for each study, increasing complexity of protocols and flat budgets. This presentation explores ways for sites to survive and succeed during this challenging time.

4:15 - 4:30 p.m. Program Q&A

CE: SoCRA Member attendees may be credited for (up to) 5.5 hours Continuing Education Credit Hours. Each participant should claim only those hours of credit that he/she actually spent in the educational activity

Catering Fee: $40.00 Payable to "The Lodge at Welch Allyn"
(This fee will cover cost of food and beverages; No charge for Parking)

Hotels: We hope you can take advantage of visiting beautiful Skaneateles Lake and be able to stay over: If so here are a few suggested hotels:

*There are add'l hotels in the Syracuse area (approximately 25 minute drive to Skaneateles)

The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area."

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New York (Western) SoCRA Chapter News

Western New York State Chapter Fall Program

Date: Saturday, November 12, 2011

Place:
Gaylord Meeting Hall
Research Studies Center
Roswell Park Cancer Institute
Buffalo, NY 14203

Objectives of the program:

  • Learn about the New SoCRA Western New York Chapter
  • Understand the cause and effect of Tumor Lysis Syndrome with relation to treatment and response
  • Understand best practices that contribute to a successful Phase I program
  • Explain the AAHRPP accreditation process and the benefits of accreditation
  • Summarize the role and responsibilities of a Implementation Associate and advantages of the position for clinical research team

CE: SoCRA continuing education = 4.25 credit hours for SoCRA Members

Schedule of Events

8:00 am
Registration - Continental Breakfast with coffee/tea

8:30 -8:45
"Welcome from Western New York Chapter of SoCRA"
Virginia Doran, MLT, MBA, CCRP
Chair Western New York Chapter SoCRA
Administrator - Regulatory Affairs
Roswell Park Cancer Institute

8:45 - 9:45
"Tumor Lysis Syndrome"
Presenter: Beverly A. Landrigan, RN, BSN, MS
Oncology Community Science Liaison
Sanofi U.S. Oncology

9:45 - 10:45
"Phase I Research Program at Roswell Park Cancer Institute"
Presenter: Dawn DePaolo, MS, BSN, RN, CCRP
Clinical Research Administrator - Phase I Program
Roswell Park Cancer Institute

10:45 - 11:00
Break

11:00 - 12:00
"Benefits of AAHRPP Accreditation to Human Research Protection Programs"
Presenter: Donald J. Handley, MSc, MBA, CIP
Administrative Director, Office of Research Subject Protection
Roswell Park Cancer Institute

11:45 - 12:45
"The IRA Is a Real Advantage in Clinical Research"
Presenter: Eileen Healy, MS, CCRP
Implementation Associate
Roswell Park Cancer Institute

12:45 - 1:00
Questions

Program Conclusion

Admission Fee: There is no fee for this event

Suggested Hotel:
DoubleTree Club Buffalo Downtown
125 High Street
Buffalo, NY 14203 (716) 845-0112

Return the form via e-mail by November 07, 2011 to:
Virginia Doran, MLT, MBA, CCRP
Virginia.doran@roswellpark.org
716-845-1348

Please share this announcement with your colleagues.

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North Carolina (East) SoCRA Chapter News

Greetings,

The February 2012, meeting of the Clinical Research Professionals of North Carolina (a chapter of SoCRA also referred to as NC East or the RTP chapter) will be held on Monday, 6 February, at Duke Clinical Research Institute (DCRI), Durham, from 6:00 to 7:00 PM.

A brief summary of the program and a biosketch forthe speaker can be found below.

DATE: Monday, February 6, 2012, 6:00-7:00 PM

PLACE: Duke Clinical Research Institute (DCRI)

OUR TOPIC: Is the Consent Form Appropriate?

SPEAKER: Cresha Cianciolo, RN, CCRP, Clinical Research Associate, Duke Clinical Research Institute

Many times Site Investigators delegate their site coordinators to manage IRB submissions and develop an Informed Consent to correspond with a new protocol. Often there is little guidance or support available within the office/practice. This presentation will review the expected elements required by the Code of Federal Regulations under Title 21, as well as Title 45. The basic elements as well as the additional elements will be discussed. Upon completion of this presentation the participants will have a general understanding of what to include in an Informed Consent Form (ICF) and what resources are available to assist in this endeavor.

ABOUT OUR SPEAKER: As a nurse, Ms. Cianciolo was fortunate to work in several high powered university medical centers as a critical care nurse. She did this for over ten years before going into the research arena. She started as a site coordinator mostly working on cardiology studies for over a decade. She is currently a Clinical Research Associate at the Duke Clinical Research Institute where she has guided site coordinators in the art of research for over 18 years. Of special note, Ms. Cianciolo is proud of the fact that she is one of the founding members of our local SoCRA chapter.

CREDIT HOURS: This program offers 1.0 SoCRA CEUs

If you have any questions, please contact Joyce Arnold-Avant at jmarnold@cato.com or at any of the numbers below:
Phone (919) 768-1201 -- Fax (919) 361-2290 -- Cell 452-0905

Directions to Duke Clinical Research Institute-North Pavilion

  1. From I-40 West take the Durham Expressway/ NC 147 (Exit 279B)
  2. Continue on the Durham Expressway. Exit on Hillandale Rd/Fulton St. (exit 15b)
  3. Stay in the left lane.
  4. At the light at the bottom of the ramp, turn left onto Fulton Street.
  5. Go past the parking garage and North Pavilion Buildings
  6. Turn left onto Pratt St.,
  7. Take the first drive on the left, at the stop sign, turn left again towards the front of the building
  8. Enter garage at the "Patient and Visitor Only" entrance. You will need to take a ticket to enter.
    The numbers of the garage floors do not match the floors in the building, so the main entrance of the building is actually Floor 2 of the garage.
  9. As soon as you enter the building (security is on your right), a flight of stairs is directly in front of you. You may go down these stairs and turn right. Lecture hall is on your right, adjacent to the food kiosk.
    OR you may turn left as you enter the building to the elevators, going to the Lower Level. Go down the hall. Lecture Hall will be on your left.

From Charlotte, Greensboro and areas West of Durham

  1. Take 85 North, past Greensboro, Burlington, 85 will merge with 70, and later with 15-501 by-pass
  2. Get off exit at Hillandale Road, Exit 174
  3. Turn right, go past the Hillandale Golf course
  4. Continue straight, go under 147, Street name will change to Fulton
  5. Go past the Duke University parking garage and North Pavilion buildings
  6. Turn left onto Pratt Street, which is the first left
  7. Continue on Pratt (very short road). Take your first left.
  8. At the stop sign, turn left again toward the front of the building
  9. Enter garage at the "Patient and Visitor Only" entrance. You will need to take a ticket to enter.
  10. The number of the garage floors do not match the floors in the building, so the main entrance of the building is actually Floor 2 of the garage
  11. As soon as you enter the building (security is on your right), a flight of stairs is directly in front of you. You may go down these stairs and turn right. Lecture hall is on your right, adjacent to the food kiosk.
    OR you may turn left as you enter the building to the elevators, going to the Lower Level. Go down the hall. Lecture Hall will be on your left

Please share this announcement with your colleagues.

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North Carolina (Winston-Salem/Northwest) SoCRA Chapter News

The Northwest NC (Winston-Salem) SoCRA Chapter is pleased to invite you . . .

Event: Educational Opportunity

Date: Thursday, December 8, 2011

Time: 12 Noon - 1 PM

Feel free to bring your lunch. Vending machines are available. A cafeteria is located on the 1st floor (the menu is available online at http://go.compass-usa.com/wellsfargo-wsmain/content/menus/menumain.pdf).

Topic: Health Disparities Research

Overview: This presentation will give an overview of the issues surrounding racial and ethnic health disparities, and research approaches to address these issues.

Presenter: Ronny A. Bell, PhD, MS

Dr. Bell is a Professor in the Department of Epidemiology and Prevention in the Division of Public Health Sciences and Co-Director of the Maya Angelou Center for Health Equity at the Wake Forest University School of Medicine. His research focuses on chronic disease epidemiology with particular emphasis on racial and ethnic minority groups. He is Vice-Chair of the North Carolina American Indian Health Board and a member of both the North Carolina Diabetes Advisory Council and the American Indian Alaska Native Workgroup of the National Diabetes Education Program.

Location:
Wachovia Center
21st Floor, Room 2164-B
100 North Main Street
Winston-Salem, NC 27101

Map of Downtown Winston-Salem:

Click on the link below for a map of the city which indicates public parking locations and the transit center located 3 blocks north of the meeting site.
www.dwsp.org/files/downtownmap.pdf

People located on the WFUBMC campus may use the shuttle marked "Research Park".

SoCRA CEUs: Certified Clinical Research Professionals may claim up to one hour.

Contact: Carrie C. Williams, ccwillia@wfubmc.edu, 336-716-6321

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Ohio "Northeast" SoCRA Chapter News

Date: Tuesday May 25, 2010

Time:

  • 5:30 – 6 Dinner and networking
  • 6 – 7 pm Panel Presentation

Location:
Cleveland Clinic Independence Family Health Center
Crown Centre II
Meeting Room B-Lower Level
Independence, OH 44131

Food:
Pizza and salad will be provided by Summa Health.

Topic:
Panel Discussion on Ethical Issues in Genetic Research
Please come prepared with questions for our panel members

Guest Speakers:

  • Julie M. Aultman, Ph.D., philosopher and bioethicist by training, is an Associate Professor of Behavioral and Community Health Sciences at Northeastern Ohio Universities Colleges of Medicine and Pharmacy.
  • Jessica Mester is a Genetic Counselor Study Coordinator at Cleveland Clinic.
  • Aaron Goldenberg is an Assistant Professor in the Department of Bioethics at Case Western Reserve University (CWRU). He is also Assistant Director of the Center for Genetic Research Ethics and Law and Assistant Director of the Department’s Master’s Program.

Objectives:

  • Describe some of the ethical issues specific to genetic research
  • Describe some of the current issues involving genetic research such as the court decision involving the Havasupai Indians
  • Explain some of the challenges to ensuring informed consent

SoCRA CEUs: 1.0

All are welcome (SoCRA & non-SoCRA Members) to attend our Northeast Ohio Local Chapter Meeting. This will be a great opportunity to network with other research professionals.

PLEASE RSVP TO
Please RSVP with your name and email to Dawne Bowman
at dbowman@clinicalrm.com or 330-278-2343

DRIVING DIRECTIONS:

Independence Family Health Center
5001 Rockside Road, Crown Centre II
Independence, OH 44131
Ph: 216.986.4000 or 800.544.6333

From North

  1. I-77S
  2. Take exit 155 toward Rockside Rd/Independence/7 Hills
  3. Turn right at Rockside Rd
  4. Take the 1st right onto W Creek Rd
  5. The Cleveland Clinic Independence Family Health Center is on the right in the Crown Centre II building.

From South

  1. I-77 N
  2. Take exit 155 for Rockside Rd toward 7 Hills/Independence
  3. Turn left at Rockside Rd
  4. Take the 1st right onto W Creek Rd
  5. The Cleveland Clinic Independence Family Health Center is on the right in the Crown Centre II building

From West

  1. I-480 E
  2. Take exit 20B for I-77 S toward Akron
  3. Follow signs for Rockside Rd/Independende/7 Hills
  4. Turn right at Rockside Rd
  5. Take the 1st right onto W Creek Rd
  6. The Cleveland Clinic Independence Family Health Center is on the right in the Crown Centre II building

From East

  1. I-480 W
  2. Keep left at the fork to continue toward Rockside Rd
  3. Keep right at the fork, follow signs for Rockside Rd/Independende/7 Hills
  4. Turn right at Rockside Rd
  5. Take the 1st right onto W Creek Rd
  6. The Cleveland Clinic Independence Family Health Center is on the right in the Crown Centre II building

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Oklahoma SoCRA Chapter News

Dear Colleague,

You are invited to our next Oklahoma SoCRA Chapter meeting:

When: Wednesday, April 13th; 11:30 AM -1:00 PM

Where: OUHSC Robert Bird Library
Provost Conference Room #223

Topic: “HIPAA issues related to Research”

Synopsis: This presentation will provide an overview of HIPAA issues related to research, including proper authorization, use, and disclosure of PHI in the research context.

Presented by:
Jill Bush Raines
Legal Counsel and University Privacy Official
University of Oklahoma Health Sciences Center

RSVP to :
Christina-Gonzalez@ouhsc.edu

(405) 271-4412 X42551

CE: 1 hr. Continuing Education Credit available

Directions and parking information: The OU Health Sciences Center Bird Library is located at 1000 S.L. Young Blvd. Enter building from the East side and cross lobby to Room #223. Parking located just South of Building (J lot) on 10th street. You will need to bring the parking ticket in to have it validated.

A map of the campus is located at: www.ouhsc.edu/about/findus.asp

Please mark your calendars and feel free to bring anyone that may benefit from this talk.

We will be having a "Taco Salad" pot luck lunch. If you do not wish to participate in the potluck then feel free to bring your own lunch.

What we need:

  • Cheese
  • Lettuce ( 2 heads or large bag) X 3
  • Any dish you think would be good
  • Diced onions(1small)
  • Tortilla Chips
  • Beans: kidney, black, refried
  • Fruit or fruit salad
  • Sour cream
  • Guacamole
  • Picante sauce Black olives - chopped
  • Dessert X2
  • Bottle of Catalina dressing
  • Bottle of Ranch Dressing
  • Diet DP & Diet Coke
  • Coke & DP
  • Diced tomatoes
  • Queso
  • Raw Veggies: carrots, celery, broccoli, cauliflower etc:
  • 7 layered dip

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Oregon SoCRA Chapter News

Program to be announced.

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Ottawa, Ontario Canada SoCRA Chapter News

Wednesday, April 6th, 2011

4:30 pm - 5:30 pm

Topic: Maternal Obesity Management (MOM) Trial

Presented by:
Kristi B. Adamo MSc, PhD
Research Scientist
Healthy Active Living and Obesity Research Group (HALO)
Children's Hospital of Eastern Ontario Research Institute

Objectives:

At the end of the presentation:

  • The participants will have a greater understanding of the importance of obesity in pregnancy.
  • The participants will have a greater understanding of the importance of obesity in gestational weight gain.
  • The participants will have a greater understanding of the importance of the intrauterine environment downstream on childhood obesity.

Location:
The Ottawa Hospital, Riverside Campus Amphitheatre
Lower level (Follow the signs)

One Continuing Education Credit Hour may be claimed for SoCRA member's attendance at this presentation.

Videoconferencing available for Ontario sites with ability to connect to OTN
Contact Judy Cheesman for information

Contact Information: Co-Chairs of the SoCRA Ottawa Chapter:

Brenda Bradley, RN CCRP
Phone: 613-737-7600 ext. 3055
Email: bbradley@cheo.on.ca

Or

Judy Cheesman, RN, C NephC, CCRP
Phone: 613-738-8400 ext. 82514
Email: jcheesman@ohri.ca

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Pennsylvania / Delaware Valley SoCRA Chapter News

The Pennsylvania/Delaware Valley SoCRA Chapter is pleased to announce our next meeting. All are welcome to attend our education program, no membership required.

DATE: Tuesday, January 31st, 2012

TIME: 4:30-6:30 PM

LOCATION:
*Lankenau Medical Center Auditorium*: Address: 100 Lancaster Avenue Wynnewood, PA 19096

Note: the Lankenau Medical Center Auditorium is located at the Main Entrance of the hospital, taking the stairs or elevator to the ground floor. Stairs are located to the right of the information desk in the main lobby.

TOPICS:

"Pharmaceutical Sponsor Activities to Assess GCP Compliance"

FEATURE PRESENTERS:

  • Veronica Hersch
    Senior Specialist, Johnson & Johnson
  • Penny Jegede
    Senior Specialist, Janssen Pharmaceutical Companies of Johnson & Johnson

ABOUT OUR PRESENTERS:

  • Veronica Hersch is a Senior Specialist in Therapeutic Area Clinical Quality Assurance/Global Clinical Quality Assurance for Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
  • Penny Jegede is a Senior Specialist in Global System Quality Assurance and Research and Development Quality Assurance for the Janssen Pharmaceutical Companies of Johnson & Johnson.

OBJECTIVES:

  • To reinforce the need for GCP (Good Clinical Practice)
  • To highlight current regulatory compliance initiatives
  • To gain insight into sponsor efforts to achieve GCP compliance from the collaboration of two quality groups: Global Clinical Quality Assurance and Global System Quality Assurance

CREDIT HOURS: SoCRA members may claim up to 2.0 SoCRA CEUs for SoCRA recertification.

ATTENDANCE: Program is FREE and is open to SoCRA & Non-SoCRA members. We thank Drexel University for their support of this program, including light refreshments during the meeting.

QUESTIONS: Chapter Chair: Michele Sellers, MSN, RN, CCRP: sellersm@mlhs.org

DIRECTIONS:

Lankenau Hospital is located just outside the western city limits of Philadelphia in Wynnewood, Pennsylvania (Lower Merion Township; Montgomery County). Once in Philadelphia, you can get to Lankenau by car, taxi, train, or bus.

Driving Directions:

  • From the North
    Take I-95 South to Philadelphia. Exit I-95 onto I-676/76 West in Philadelphia. Exit I-76 onto City Avenue, and turn right at the bottom of the ramp. Travel several miles South on Route 1 (City Line Avenue) to the intersection of Route 30 (Lancaster Avenue). Turn right onto Lancaster Avenue to the first traffic light. The hospital will be on your left.
  • From the South
    Take I-95 North. Exit I-95 onto I-476 North. Exit I-476 at the Route 1 Exit. Follow Route 1 North several miles to Route 30 (Lancaster Avenue). Turn left on Route 30 (West) to first traffic light. The hospital will be on your left.
  • From the East/West
    Take the Pennsylvania Turnpike to the Valley Forge Interchange (Exit 326). Exit onto I-76 East. Follow to Route 1 Exit (City Line Avenue). Exit South onto Route 1, follow for several miles to Route 30 (Lancaster Avenue). Turn right (West) onto Route 30 to first traffic light. The hospital will be on your left

Public Transportation

To map your trip or to find out about possible delays, visit the SEPTA site.

From Center City Philadelphia
BY TRAIN, from Philadelphia’s 30th Street or Suburban Station, take SEPTA’s R5 “Paoli Local” to either Overbrook or Wynnewood. From Overbrook, it is a fifteen-minute walk up City Avenue to Lancaster, then west along Lancaster to the Hospital. From Wynnewood, it is possible to catch the 105 bus; ask a SEPTA official or look for the sign marking the stop in the parking lot across the street.

BY SUBWAY AND BUS, take the Market-Frankford Elevated line to the 69th Street terminal, and transfer to the 105 bus to Lankenau. The SEPTA G bus, which serves major portions of the city, also stops at Lankenau.

PARKING: 2 Options:

Lot A and Lot B Parking: **Charges apply**. Note: Lots A & B parking areas are the closest to the hospital auditorium. Parking Lot A, is located near the front of the main hospital entrance. Charges are the responsibility of the attendee.

Campus Construction: Note Signs for Parking: Conference Parking is available free of charge (space permitting). Note: this is located at the rear of the hospital, next to the Employee Parking Lot. It will require walking a reasonable distance to walk to the front entrance of the Hospital.

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Pennsylvania Harrisburg/Hershey SoCRA Chapter News

You are invited to the first SoCRA Harrisburg/Hershey Chapter Organizational Meeting.

January 26, 2012

6:00- 7:30 PM

Room C6805
Penn State College of Medicine
500 University Drive, Hershey, PA 1 7033

  • Information about future training and networking opportunities
  • Provide your feedback in surveys and discussion
  • Show your support for a new local chapter of SoCRA

Note: This is an organizational meeting and it offers no CEU

Clinical Trial Professionals

~ Open to all - SoCRA members, certified SoCRA members, and those not affiliated with SoCRA ~

RSVP/Questions: Kathryn Byrnes
717.531.3098
kbyrnes@hmc.psu.edu

Directions: (see map)

  • Use the main Penn State Hershey entrance at University Drive and Governor Road / Rt. 322.
  • From University Drive bear right onto Campus Drive.
  • Parking lots on the left are available for visitors to the College of Medicine.
  • The building entrance is #14 on the map.

Visitors are recommended to park in Centerview Garage #7, but may find open spots at any of the P's on the map. #14 on the map is the entrance for the meeting. Visitors are asked to park on levels 1 or 2 of the Centerview garage at the corner of Centerview and Campus Drives. There is then the option to take a free van to the College of Medicine or walk. Visitor parking is free of charge.

Please share this announcement with your colleagues.

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Tennessee, Greater Nashville Regional SoCRA Chapter News

The Greater Nashville Regional SoCRA Chapter will offer the following program: Re-identification Risks in Clinical Biobanks

Bradley Malin, PhD
Associate Professor of Biomedical Informatics
Associate Professor of Computer Science

Date/Time:

  • Wednesday, January 25, 2012
  • 12-1 pm

Place:
898B Preston Research Building
Vanderbilt University Medical Center

Various regulations and policies permit the collection and dissemination of de-identified data and biospecimens. However, there are various studies which suggest this data is at grave risk of unsanctioned "re-identification". This seminar will review how re-identification transpires, the extent to which it will transition from theoretical to practical concern, and how we can mitigate the risk without precluding biomedical research.

At the conclusion of the presentation, participants will be able to:

  • Discuss the risks of data re-identification.
  • Describe policies and legal controls for biomedical data collection and use.
  • Characterize risks as "possible" vs. "probable".

Sponsorship: Jointly sponsored by Vanderbilt School of Medicine; Department of Medicine, Division of Rheumatology and the Society of Clinical Research Associates.

Accreditation and Credit Designation: This activity has been planned and implemented with the Essentials Areas and Policies of the Accreditation Council for CME (ACCME) through the joint sponsorship of Vanderbilt School of Medicine and the Society of Clinical Research Associates. Vanderbilt School of Medicine is accredited by the Accreditation Council for CME to provide continuing medical education for physicians. Vanderbilt School of Medicine designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty Disclosure Statement: It is the policy of Vanderbilt School of Medicine to require disclosure of financial relationships from individuals in a position to control the content of a CME activity; to identify and resolve conflicts of interest related to those relationships; and to make disclosure information available to the audience prior to the CME activity. Presenters are required to disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentations.

Commercial Support: This educational activity received no commercial support.
All course directors, planners, and speakers indicated no financial relationships to disclose.

Members and non-members welcome.

For directions, please contact annette.oeser@vanderbilt.edu

CE: SoCRA has approved this program for 1 continuing education contact hour for members.

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Tennessee, Mid-South SoCRA Chapter News

"E-Research"

Thursday, February 3, 2011

Location:
St. Jude Children's Research Hospital Auditorium
ALSAC Tower, 2nd Floor
262 Danny Thomas Place
Memphis, TN 38105

Agenda:

7:30 a.m. Registration

8:00 a.m. Welcome

8:25 a.m. Process of Establishing a Secure Electronic Clinical Data Website

Charles Hurmiz and Tad McKeon, Research Informatics Directors, St. Jude Children's Research Hospital

  • Describe current industry best practices in remote data entry (RDE)
  • Describe Health Insurance Portability and Accountability Act (HIPAA) and 21 CFR Part 11 concerns in a web based RDE system

9:30 a.m. The HIPAA Ramifications of a Security Breach

Morris Landau, JD, MHA, LL.M., Privacy Officer, St. Jude Children's Research Hospital

  • To understand what is a "breach" under the "HITECH Act"
  • To understand what are the federal requirements of a security risk assessment under HIPAA
  • To understand the federal and state requirements if a breach of security occurs
  • To understand the new requirements of contractors known as "Business Associates" under the HITECH Act

10:30 a.m. Networking Break

11:00 a.m. Guidance for Industry: Computerized Systems used in Clinical Investigations
Jamey Ramsey, Biostatistics & Data Management, Manager, Smith & Nephew

  • Review Axioms of Good Clinical Data Management Practice
  • Review "FDA Guidance for Industry: Computerized Systems used in Clinical Investigations"
    • Understand scope and background of document
    • Review FDA recommendations with practical experience

12:00 p.m. Closing Remarks

Registration: Please use this link for registration
http://hospital.stjude.org/conferences/conf/SoCRAspring2011

Registration Deadline: Please register by Thursday, January 27, 2011

Cost and Parking: Attendance at the Conference is free of charge. Parking is available on the St. Jude Campus.

Target Audience: The Conference is designed for all research investigators, nurses, managers, research faculty, fellows, post doctors, research coordinators, research associates, and assistances.

Accreditation: SoCRA has designated this educational activity for a maximum of 3.0 Continuing Education Credit Hours.

(Members and Non-members are welcome)

Driving Direction to SJCRH, Memphis, TN:

Traveling West: I-40 E into Memphis. Exit 1B on Danny ThomasBlvd. Turn right on Alabama Ave. Turn right on N. Lauderdale.

Traveling East: I-40 W into Memphis.Exit 1C on Danny Thomas Blvd. Turn right on Alabama Ave. Turn right on N. Lauderdale.

Traveling North: I-55 N into Memphis. Exit right onto I-240 W. Exit I-40 W. Turn right on Exit IC on Danny Thomas Blvd. Turn right on Alabama Ave. Turn right on N. Lauderdale.

Traveling South: I-55 S to I-40 E. Exit 1B on Danny ThomasBlvd. Turn right on Alabama Ave. Turn right on N. Lauderdale.

For more information, please contact Sandra Farwell-Williams at 901-595-3570 or sandra.williams@stjude.org or Hani Rashed, M.D. at 901-595-5782 or hani.rashed@stjude.org.

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Texas, Central SoCRA Chapter News

We are pleased to announce an educational opportunity hosted by the Central Texas SoCRA chapter.

Date: December 15, 2011 from Noon until 1:00

Location:
Conference Center, Room A200B
Scott & White Healthcare
2401 South 31st Street
Temple, TX 76508

Topic: HIPAA and Research

Objectives:

  • Define HIPAA.
  • Define PHI.
  • Name two rules mentioned in Title II Administration Simplification of HIPAA that applies to research.
  • Describe four ways in which a researcher may use and/or disclose PHI without the authorization of a research participant.
  • Identify three criteria that must be met for an IRB/IEC to grant a Waiver or Alteration of Authorization.
  • Describe the difference between informed consent and privacy authorization.

Presented by:
Sarah Allenson, BS, CCRP
Clinical Research Coordinator III
Scott & White Healthcare

CE: 1.00 SoCRA CEUs will be awarded for SoCRA Members

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Texas, Greater Houston/Galveston SoCRA Chapter News

The Greater Houston/Galveston Chapter in conjunction with Texas Heart Institute at St. Luke's Episocopal Hospital

Clinical Research Education Session - Transition to Det Norske Veritas and the ISO Approach to Corrective and Preventive Action

Date: Thursday, January 19th, 2012

Time: 2-3PM

Location: Texas Heart Institute at St. Luke's Episocopal Hospital, Telemedicine Conference Room (C-030)

Speaker: Lisa Bush, Regulatory & Accreditation Specialist for St. Luke's Episcopal Hospital

Presentation Objectives:

  • Describe how Det Norske Veritas incorporates ISO9001 into its accreditation program,
  • describe the main documented procedures required by ISO9001,
  • verbalize understanding of ISO9001 corrective and preventive action,
  • and verbalize the reasons for transitioning to Det Norske Veritas from The Joint Commission for Hospital Accreditation

Members and non-members welcome.

CE: SoCRA CCRPs will obtain 1continuing education contact hour for their attendance.

Please share this announcement with your colleagues.

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Texas, Greater San Antonio SoCRA Chapter News

Date: Tuesday, September 13, 2011

Time: 4:00pm-5:30pm

  1. 4:00 pm - Refreshments and Networking
  2. 4:15 pm - Educational Program Presentation
  3. 5:15 pm - Chapter Meeting. Open to all attendees.

Speaker:
Jane Jestila, BS, MS, RN
Adjunct Assistant Professor, George Washington University
Senior Clinical Research Associate, TKL Research, Inc

Title of the program:
"History of ICH and how it relates to GCP and trials in the United States"

Objectives of the presentation:

  • Review the history of ICH
  • Identify the key principals of ICH
  • Describe the relationship between the FDA regulations and ICH GCP
  • GCP guidelines and standards

Location of Meeting:
Cancer Therapy & Research Center
at the UT Health Science Center at San Antonio
7979 Wurzbach Rd
Grossman Bldg
4th Floor, Mabee Conference Room
San Antonio, TX 78229

Directions:
CTRC is located on Wurzbach Rd. between Medical Dr. and Floyd Curl Dr.
Map: http://utmaps.uthscsa.edu/?urlname=5&urlid=147

Parking: Parking will be validated.

Cost: Program is FREE and is open to ALL SoCRA & Non-SoCRA members!

Food: Water and light refreshments will be available.

SoCRA CEU Credit: 1.0 hour CE is available for SoCRA members. Certificates of attendance will be provided.

RSVP: Please RSVP by June 14, 2011

For more information and to RSVP: please contact the San Antonio Chapter Chair Ellen R. Jones or Co-Chair Anna G. Taranova at SoCRASanAntonio@gmail.com or 210-450-5863

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Texas, West SoCRA Chapter News

Date/Time: Thursday, September 29, 2011, 12:00 CST*

Topic: "Negotiating Clinical Trial Budgets"

Speaker:
Ann Purdom, RN, MSN, OCN
Manager, Office of Clinical Research
Southwest Cancer Treatment and Research Center

Upon completion of this presentation the participants will:

  • Identify the 3 "Easy Steps" for negotiating Clinical Trial Budgets
  • Explain in practical terms the considerations necessary for analyzing Clinical Trial protocols
  • Identify and explore costs incurred to sites when conducting Clinical Trials

Locations:

  • Lubbock - ACB 230 (Academic Classroom Building - located at front of HSC on 4th and Indiana)
  • *El Paso - 235 (*11:00 AM)
  • Amarillo - 4720
  • Odessa - 2C91

For further information: Terry Fountain, CCRP, 806-775-8590

For those who want a SoCRA Certificate, please RSVP. All others are welcome to just show up.

Please RSVP by Tuesday, September 27: terry.fountain@umchealthsystem.com

Feel free to bring lunch.

*1.0 Continuing Education Credit hour for SoCRA members towards CCRP Renewal will be awarded.

All SoCRA meetings are open to members and non-members.

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Tokyo, Japan SoCRA Chapter News

Japan SoCRA Chapter Meeting in conjunction with NPO CORE

Japan SoCRA Chapter and NPO CORE are pleased to announce the educational seminar for CRPs on Saturday, July 30, 2011 in Tokyo. Susan Devine is Senior Manager of the Clinical Trials Support Unit, Hematology/Oncology/Bone Marrow Transplant Division at the Hospital for Sick Children in Toronto where she also serves as a member of the Advisory Council of the Sears Cancer Center. With nearly 30 years experience in pediatric cancer clinical trials, Susan teaches the Certification Prep and Review Course for the SoCRA and she is immediate past Treasurer of SoCRA's Board of Directors.

Date: Saturday, July 30, 2011

Time: 17:30 - 19:00 (after the CCRP Exam)

Location:
Kitasato University, School of Bioscience Building
Room 211
5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642 JAPAN

Directions map: www.pharm.kitasato-u.ac.jp/location-e.html

Target: Clinical Research Professionals

Program:

  1. 17:00 - 17:30 Registration
  2. 17:30 - 19:00 Lecture and Discussion

Title: SAE Reporting to NCI

  • Reporting procedures to NCI including exact example
  • How NCI evaluate SAEs and feedback to each institution
  • CTEP, NCI GUIDELINES: ADVERSE EVENT REPORTING REQUIREMENTS

Speaker: Susan Devine, CCRP

Language: English only

CCRP credit: 1.5CE

Participation fee: free

Japanese information: www.crsu.org/SoCRA_Japan/

Advanced registration: Please email SoCRAJapan_Committee@umin.ac.jp including your name, affiliation, SoCRA member or non-member by July 20, 2011.

This program is co-hosted by Japan SoCRA Chapter (www.crsu.org/SoCRA_Japan/) and
Non-Profit Organization Clinical Oncology Research and Education
(NPO CORE: www.core.or.jp/index.htm ).

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Toronto, Canada SoCRA Chapter News (Greater Toronto)

Greater Toronto Area Chapter presents:
Resistance Is Futile: I'm Positive! Collaboration coaching between Sponsor, Sites and You

Speaker:
Christine Watters
Natalie Currie
The Way Finding Coach
Life, Career and Corporate Coaching
Natalie Currie Enterprises Inc.

This presentation will address:

  • Discover what resistance is and how to indentify it when interacting with sites.
  • Determine how and why resistance can delay or inhibit meeting recruitment target and study milestones.
  • Discover and implement tools to dissolve resistance and achieve study targets and goals.

CE: This session will provide 1 CE credit for SoCRA members

Date: Thursday, Oct 20, 2011

Time: 6:00pm-7:30pm

Location:
Princess Margaret Hospital Auditorium
RM 6-605
610 University Avenue, TO, ON

RSVP:
susanna.sellmann@uhnresearch.on.ca

Videoconferencing is available via the Ontario TeleHealth Network:

If you plan to attend videoconference at CREDIT VALLEY HOSPITAL
RSVP: Marissa Tang Fong: MTangfong@cvh.on.ca

If you plan to attend via videoconference at London Health Sciences Center
Ashrafunissa Janmohammad: Ashrafu.Nissa@LHSC.ON.CA

If you plan to attend via videoconference at Hotel Dieu Hospital
RSVP: Jenna Ekborn ekbornj@queesu.ca

SoCRA CE credit: 1 hour

Please share this announcement with your colleagues.

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Utah SoCRA Chapter News

Date: Friday, September 9, 2011

Time: 9:00 a.m. to 11:00 a.m

Location:
University of Utah Health Sciences Education Building (HSEB)
26 S. 2000 East
SLC, UT 84112

Room: HSEB 2600

Title: Clean Data and Complex Trials: Can this Marriage be Saved?

Speakers:

  • Jeri Burr, MS, RN-BC, CCRC-University of Utah
  • Sally Jo Zuspan, MSN, RN-University of Utah
  • Brittan Browning, MS, RD, CCRC-University of Utah
  • Rene Enriquez, BS-University of Utah

Brief Program Description: Interactive discussion on clinical trials data in multicenter research. 9:00-10:45 Presentation, 10:45-11:00 Discussion.

Program Objectives:

  • Recognize the logistics and infrastructure necessary for data quality control in investigator-initiated multicenter studies.
  • Identify methods used to recognize common but difficult to detect errors frequently present in data sets of multicenter clinical trials and describe ways to minimize their impact on the final data set.
  • Describe the components of technical solutions used by a data coordinating center (DCC) within the management of clinical trial projects.

Directions and Parking:

The HSEB is on the University of Utah campus. There is limited visitor parking available on campus. Please refer to the web site for information on directions and parking: http://hseb.utah.edu/

Continuing Education:

Up to two hours of CE are available for this program for SoCRA members. SoCRA members will also receive Certificates of attendance at the completion of the event.

Contact Person: Gina Gregovich gina.gregovich@hci.utah.edu or 801-582-8202. RSVP is not required for this event.

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Vancouver, Canada SoCRA Chapter News

We are pleased to announce a meeting for the SoCRA Vancover Island Chapter on December 2, 2011 at the Royal Jubilee Hospital, Begbie Hall, 1952 Bay Street, Victoria, BC V8R 1J8.

Topic: 8 th Vancouver Island Clinical Research Education Symposium

Date: Friday December 2, 2011

Time: 0815-1215

Location: Royal Jubilee Hospital

Meeting Room: Woodward Room, 124.

Contact person: SoCRA Chapter Chair, Anika Patel

Email: helix@telus.net

Tel#: 250-704-9919

TO REGISTER: Email your contact details, position and affiliation to: Anika.Patel@viha.ca

CE: 3 SoCRA CEUS will be awarded to SoCRA Members. Certificates of attendance are only given to members.

Topics to be discussed:

Join us on December 2nd for an update to your GCP and regulatory knowledge provided by one of BC's top regulatory experts. Rosalie Chartrand-Rodrigue, Head of Clinical and Quality Compliance at Vifor Pharma will present an overview of new trends in global GCP compliance requirements, highlighting recent audit findings and how you can ensure that your knowledge is current in this always-changing field. This will be followed by an innovative group interactive session, which will test your collective knowledge and identify and fill any gaps. This high-energy portion of the morning will also provide some competitive fun between the Sponsors, Monitors and Site Personnel in attendance.

Learning Objectives:

  • Update on new or revised regulatory and GCP requirements
  • Description of recent trends in global GCP audit findings, (including root cause and suggested preventative actions)
  • Recommendations for strengthening procedures, documentation practices or training to meet new or revised requirements
  • Identification of and training on gaps in selected GCP topics

Target Audience: Monitors, Clinical Research Coordinators, Site Managers, Investigators, Project Managers, Data Managers, Lab and Pharmacy Research Coordinators

0815-0845 Registration and Coffee

0845-0900 Welcoming Comments and Continuing Education

0900-1000 GCP UPDATE: ADVANCED REFRESHER

Rosalie Chartrand-Rodrigue

1000-1045 WORKSHOP - GCP CHAMPIONSHIP

Come and challenge other sectors of the industry.

Rosalie Chartrand-Rodrigue

1045-1100 Health Break

1100-1200 Results, Discussion and Rationales for Answers

Please share this announcement with your colleagues.

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Vancouver Island, Canada SoCRA Chapter News

We are pleased to announce a meeting for the SoCRA Vancouver Island Chapter on December 3, 2010 at the Royal Jubilee Hospital, Begbie Hall, 2192 Richmond Road, Victoria, BC V8R 1J8.

Topic:
6 th Vancouver Island Clinical Research Educational Symposium
From Collection to Validation: Practical Issues and GCP Compliance in Clinical Data Management

Date: December 3, 2010

Time: 0815-1300

Location: Royal Jubilee Hospital

Meeting Room: Woodward Room, 124l

Contact person: SoCRA Chapter Chair, Anika Patel
Tel#: 250-370-8764

To Register:
Email your contact details, position and affiliation to: Karen.coles@viha.ca

2.5 SoCRA CEUs will be awarded

Topics to be discussed include:

The upcoming event will focus on a central theme of data management, encompassing the perspectives and advice of three of the most significant stakeholders in the process:

  • Regulatory Authorities
  • Sponsors/CROs
  • Investigational Sites.

The learning objectives will be to:

  • Gain a better understanding of the "big picture", or the successive steps involved in ensuring high quality data and what the realities are for personnel working in the various environments related to the collection, processing and validation of data.
  • Review the common audit findings in the area of data and data based systems that occur at the site and organizational levels.
  • Learn some of the corrective and preventative actions in response to these issues to ensure ongoing compliance, quality data and good practice.
  • Find out about the stringent requirements faced by industry to ensure high quality data and how this directly impacts sites though data collection strategies (including EDC vs. paper), monitoring and querying.
  • Discover the realities of working with different systems, handling queries and the challenges of database freezes and locks on workload and hear practical suggestions on how to improve the efficiency and reduce the stress for all parties involved!

8:15 - 8:45 Registration and Coffee

8:45 - 9:15 Welcome & Introductions

9:15 - 10:00 Derogate Data or Data Devine
Jean Smart, Clinical Compliance Consultant, Smart and Associates

10:00 - 10:45 What We Do and Why We Do it: A Behind the Scenes Look at Clinical Data Management
Melanie Lougheed, MSC, Director Clinical Data Management, PRA International Heather Cosman, BSc, PMP, Lead Data Manager, PRA International

10:45 - 11:00 Health Break

11:00 - 11:45 Data Collection and Queries: the Good, the Bad and How to Avoid the Ugly
Fiona Auld, BSN, CCRP Research Coordinator, VIHA
Karen Coles, RN, CCRC Acting Manager, Research &Academic Development, VIHA

11:45-12:00 Questions and Discussion

12:00-13:00 Networking Lunch

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Virginia, Roanoke SoCRA Chapter News

The Roanoke Valley SoCRA Chapter is pleased to announce the next scheduled meeting:

Date: Thursday, September 15, 2011

Time: 1:00-2:30 PM

Location:

Carilion Roanoke Memorial Hospital (CRMH)
6th floor Auditorium
1906 Belleview Ave.
Roanoke, Virginia 24014

Guest Speaker:
Chuck Hite, Biomedical Ethics/Research Director
Carilion Clinic
Roanoke, Virginia 24014

Topic: "Ethics in Human Subjects Research: Balancing Risks and Benefits and Selecting Research Subjects."

1.5 hours of SoCRA Continuing Education Credit will be awarded to SoCRA members for attending.

If you have any questions or need additional information, please contact Dawn Bowles, RN, CCRP at dmbowles@carilionclinic.org

Free paking is available in the Parking Garage, and there is no charge for attending.

Objectives:

  • Review the two fundamental ethical principles that guide review of research risks and protection of vulnerable subjects as outlined in the Belmont Report of 1979
  • Examine how these two ethical principles are translated into regulatory requirements
  • Discuss the practical application of these ethical principles and regulatory requirements to research protocols

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Virginia (Southeastern) SoCRA Chapter News

The Southeastern VA Chapter of SoCRA is pleased to announce their first local educational event.

Date: Wednesday, Oct 13 2010

Time: 10:00 - ll:30 AM

Place:
Sentara Heart Hospital, 600 Gresham Drive, Norfolk, VA 23507
Conference Rooms A and B

Speaker:
Tammy Anderson, CCRC, CCRA, CRCP, Director, Clinical Trials Office
Virginia Commonwealth University, Richmond, VA

Topic: "The Changing Landscape of Clinical Research: Impact to Individual Sites"

Objectives: Commander Secrist's will discuss:

  • The impact of increasing costs of drug development, increasingly difficult study protocols, and complex regulatory requirements on clinical research sites
  • Actual performance versus projected performance (as reported in feasibility surveys) at clinical research sites
  • The changing demographics of investigators and research staff
  • The impact of globalization on clinical research sites
  • The advantages and disadvantages for industry in choosing Academic Medical Centers' clinical research sites

CEUs: This presentation will provide 1.5 CEUs

Please RSVP to: nanezkf@evms.edu

Questions or Comments to: perkinsr@evms.edu

Parking:
Sentara Heart Hospital has provided a parking pass for all attendees of this event. The pass will be emailed to you with your RSVP confirmation

Driving Directions:
Sentara Heart Hospital Visitor's Guide and Directions

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Vermont SoCRA Chapter News

Date: Wednesday, March 31, 2010

Time: 12:00-1:00 EST

Title of Program:
Requirements for Clinical Trial Registration (Clinicaltrials.gov)
A Mandate: Clinical Trials Registry Data Bank

Speaker Name: Ellen Travis, FNP, MSN

Location:
The University of Vermont/Fletcher Allen Health Care
General Clinical Research Center (Baird 7)
Burlington, Vermont 05401

1.0 SoCRA continuing education credit hours approved*

*SoCRA accepts documentation of candidate participation in continuing education programs for re-certification for programs applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.

Directions:

From I-89 North or South

  1. Exit 14 W
  2. Bear RT onto East Avenue
  3. The University of Vermont/Fletcher Allen Health Care on LT
  4. Parking garage on RT, valet parking available at main entrance
  5. From Main Entrance follow signs to Baird Building
  6. Take Baird Elevators to 7th FL

Program Objectives :

Participants will lean the principles guiding registration of clinical studies through National Institutes of Health (NIH) Clinicaltrials.gov. The following information will be reviewed:

  • Which studies require registration?
  • Timing: when do you submit?
  • What information is required?
  • What information for results posting is required?
  • Who is responsible for reporting?
  • How do you submit?
  • Updates to the database
  • Non-compliance
  • Regulatory documents
  • Special requirements and laws surrounding India

For more information contact the Vermont Chapter Chair:
Angela J. Ricci, MSHS, CCRP
Tel: 802-288-9007
Email: angela.ricci@av.abbott.com

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Washington SoCRA Chapter News

Washington State Chapter meeting

Date: Thursday, November 5, 2009

Time: 5:00 PM - 9:00 PM

Program: University of Washington Tumor Vaccine Group Open House
“Controlling Cancer with the Immune System”

Refreshments and hors d'oeuvres will be provided/sponsored by selected area restaurants

5:00 PM - 6:30 PM

  • Meet SoCRA Colleagues and Visitors
  • Visit Displays and Posters
  • Enjoy Refreshments

5:30 PM Lab Tours

6:30 PM Presentations:

Bench to Bedside: Controlling Cancer With the Immune System
Dr. Mary L. “Nora” Disis
Director & Founder, TVG
Professor, University of Washington
Department of Medicine/Oncology

7:30 PM Panel Discussion on Trial Participation

8:00 PM Lab Tours

9:00 PM Wrap Up

Speakers Include:

  • Dr. Mary L. “Nora” Disis
    Director & Founder, TVG
    Professor, University of Washington
    Department of Medicine/Oncology

CEU: SoCRA members may claim up to 2.5 hours of CEUs for SoCRA recertification.
Presentation 1.0; Panel Discussion 0.5; Lab Tour 0.5; Poster Session 0.5
(members may only claim actual time spent in the educational event).

Location:
Tumor Vaccine Group
University of Washington South Lake Union Campus
815 Mercer Street
Seattle, WA 98109

Free Parking On-Site
No Charge for Attendance
Refreshments provided by area restaurants in support of the TVG

SoCRA members and non-members welcome, please invite your colleagues! This event is open to the public.

RSVP: Merle Witter, CCRP
mtwitter@comcast.net

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Washington D.C. "National Capital Area" SoCRA Chapter News
(D.C., Maryland, Virginia)

National Capital Area Chapter

Wednesday, December 14, 2011

  • 5:30 pm Meet and Greet
  • 6:00 - 7:00pm Presentation

Location:
Kaiser Permanente Regional Headquarters
2101 E. Jefferson St.
Rockville, MD 20852

Room: 3rd Floor Desert Center

Please RSVP to: jamie.roberts@nih.gov

Presenter:
Michael A. Horberg, MD, MAS, FACP, FIDSA
Executive Director Research, Mid-Atlantic Permanente Medical Group
Director HIV/AIDS, Kaiser Permanente
Clinical Lead HIV/AIDS, Care Management Institute

Presentation: HIV Research in Kaiser Permanente

Objectives:

  • Research on HIV
  • HIV quality measures and care improvement
  • Determinants of optimized multidisciplinary care for maximized HIV outcomes

Credits available:
1.0 CE credit hour for SoCRA CCRP Renewal "The Society of Clinical Research Associates (SoCRA) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area."

Parking:

Underground parking is available, there is very limited outside parking. Parking is free if you park in the building garage. The garage closes at 6PM.

However, you are able to get out of the garage at all times (pull up to the entrance and the door will open). NOTE: The attendant leaves at 6PM and the garage will close. Therefore, guests need to ensure they have arrived onsite before 6PM if they want to park in the garage otherwise you will need to park outside.

Driving Directions:

The entrance to Kaiser Permanente is from Montrose Parkway. The front of the building faces Montrose Parkway and there is a stoplight at the new entrance.

Directions:

  • From I-270 south: Take exit 4A, Montrose Road east. There is a detour onto the new Montrose Parkway. Turn right at the first light on Montrose Parkway , which is at the Kaiser Permanente Regional Office. Follow the driveway to the left and park in the underground garage.
  • From the I-495 innerloop: Take the I-270 split north to exit 4A, Montrose Avenue east. There is a detour onto the new Montrose Parkway. Turn right at the first light on Montrose Parkway , which is at the Kaiser Permanente Regional Office. Follow the driveway to the left and park in the underground garage.
  • From the I-495 outerloop: Take the I-270 split and exit on Old Georgetown Road north. At the fourth light, turn left onto Executive Boulevard. Executive Boulevard becomes East Jefferson. Turn left on the new Montrose Parkway. Turn left at the first light, which is at the Kaiser Permanente Regional Office. Follow the driveway to the left and park in the underground garage.

2012 Meeting schedule

  • February 8 Desert Center 3E 5:30 pm
  • April 11 Desert Center 3E 5:30 pm
  • June 13 Desert Center 3E 5:30 pm
  • August 8 Desert Center 3E 5:30 pm
  • October 10 Desert Center 3E 5:30 pm
  • December 12 Desert Center 3E 5:30 pm

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Wisconsin SoCRA Chapter News

(SOCRA membership not required to attend. If you work in Clinical Research, this meeting may be of interest to you.)

Topic: Investigator Research Responsibility

Objectives:

  • Review Investigator and Research Team "Conduct of Research" Responsibilities
  • Explain Role of Institutional Review Board (IRB) and Good Clinical Practice (GCP) Regulations
  • Short History of CITI Training (Collaborative Institutional Training Initiative) and Research Certification

Speakers:

  • Aurora Health Care IRB Manager: Lori Roesch, CIP, CIM
  • Research Compliance Analyst: Kelly McCormick, BS, MBA

Date: January 30, 2011

Time: 5:30 pm - 7:00 pm

Place: Aurora Bay Care Medical Center

Cost: Free

**1 CE will be offered to SoCRA Members

**Meal will be provided.

**RSVP, please. If questions, email or call:

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