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Chapter Contact Page

New: Chapter Development Highlights (PDF)

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

Chapters are listed alphabetically, by state/country.

Arizona (Phoenix) Valley of the Sun SoCRA Chapter News

The Phoenix SoCRA Chapter is a quarterly forum for anyone interested or working in clinical research. The meeting is held in March, June, September and December of each year in the Phoenix metropolitan area. One continuing education credit (CEC) is available for attending the one-hour, clinical research-related presentation given by an invited speaker (attendance is free!). Past meeting summaries and selected presentations will be available at subsequent meetings.

MEETING ANNOUNCEMENT

Wednesday
December 10, 2008
6:30 – 8:30 PM

Location:
MDS Pharma Services
2420 W Baseline Road
Tempe, AZ 85283

Speaker:
Philip Bach

Speaker Title:
Clinical Site Director

Speaker Affiliation:
MDS Pharma Services

Presentation:
Phil will provide an overview of Phase 1 clinical research, describe the types of studies performed at the site and give a tour of the facility.

Summary:
We will meet the group at the main entrance of the building which is on the back side in the middle (under the big MDS sign). From there we will escort the participants to a gathering location. An overview will be given and then we can take a tour of the facility.

Light refreshments will be provided at the end of the tour. Please bring a friend and spread the word!

CEC Available: 1 Credit

Questions:
Contact Jason Jones, Phoenix SoCRA Chapter Chairperson
602-667-3948
jjones@medicis.com

Planning to Attend? Please RSVP: jjones@medicis.com

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California (Los Angeles) SoCRA Chapter News

Date: Wednesday, August 13, 2008

Time: 6:00 PM – 7:30 PM

Topic: Monitoring and Auditing to Ensure Protocol Compliance and GCP

Presenter:
Paula Miner, LVN, CCRP
Lead Clinical Trials Auditor
Office of Clinical Research Quality Assurance
City of Hope

Location:
City of Hope
Platt Conference Room 3
1500 East Duarte Road
Duarte, California

1 CE credit hour is available for SoCRA Certified Professionals

Directions: www.cityofhope.org/About/dir_campus.htm

Campus Map: www.cityofhope.org/About/campusmap.htm

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California (Northern CA) SoCRA Chapter News

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

Topic: The Essentials of Good Clinical Practices

Speaker: Daniel Redline, BA, CCRP, CCRC
Pre-Market Clinical Project Manager,
Volcano Corporation

Date and Time: Thursday January 21, 2010 from 12:00-1:00PM

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

Cost: FREE admission (All members and nonmembers welcome)

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

Rayanne Hildreth (Education & Outreach Officer)
(916) 703-9192
rayanne.hildreth@ucdmc.ucdavis.edu

*SoCRA members are credited with 1 hour of Continuing Education (CME or CNE).

Please share this meeting announcement with your colleagues.

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California (Orange County) SoCRA Chapter News

Date: Thursday, December 17, 2009

Time: 5:30-6:30 PM

Topic: Industry-Sponsored Studies Contracts and Budgets

Speaker:
Lan T. Tran, MPH
Chief Compliance Officer
Emmaus Medical, Inc.
Former Asst. Vice President, Research Administration
UCLA Biomedical Research Institiute

Location:
University of California Irvine, Main Campus
Irvine, CA 92697
Hewitt Hall, Bldg #843
1st Floor, Conference Room #1042

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 Sunga, BSMT, CCRP at (323) 271-1330, cell (323) 353-2941 or mgsmedresearch@aol.com.

CE: SoCRA members are credited with 1.5 SoCRA Continuing Education Unit.

“Please bring or submit your recruitment issues for group discussion as part of a post-presentation meeting.”

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California (San Diego) SoCRA Chapter News

Meeting Announcement

Date: February 24, 2010 Wednesday

Time: 6:00 - 7:00 PM

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

Speaker: Dr. Linda Strause, Ph.D. Executive Director, Oncology Clinical Operations, Vical, Inc.

Topic: Current Issues in Patient Recruitment

A 2006, The Center for Information & Study on Clinical Research Participation (CISCRP) survey conducted among 900 US adults found that the public’s perception regarding why people choose to participate in clinical trials is because they are ‘very sick without any other options’ or they are ‘looking to make money’. Sadly, also in this study, 34% of Americans said that they ‘Do Not Admire’ people who volunteer for clinical trials. (www.cicsrp.org)

Dr. Strause is a board member of CISCRP and will discuss with our SoCRA Chapter the current issues in patient recruitment and address concerns about ethics in recruiting. Is recruitment of subjects difficult for your clinical trial? It may be part of a larger concern.

CE: One hour CEU credit is offered for attending this session.

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 November meeting of the San Francisco Bay Area Chapter of SoCRA, the Society of Clinical Research Associates.

Topic: “Keys to a Personalized Informed Consent Processt”

  • Identify barriers to enrollment from the patient perspective
  • Recognize learning styles and tailor approach accordingly
  • Better understand various ethical implications
  • Use tools to work more effectively with patients

Speaker:

Peggy Devine, Founder & President, Cancer Information & Support Network, Inc.

Date and Time: Thursday, January 21, 2010; 2:00 – 4:00 PM

Place: UCSF/Mt. Zion campus, Lurie Conference Room, 2340 Sutter Street, 1st floor, San Francisco, CA 94115. Please stop and sign in with front desk guard.

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

Cost: FREE admission (All members and nonmembers welcome)

For more Information:
Ilana Hettena, CCRP, hettenai@cc.ucsf.edu

* SoCRA members are credited with 1.5 SoCRA Continuing Education Unit (CEU).

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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

The California SoCRA Chapter of Ventura County would like to invite you to our exciting 2009 Spring Program which will be hosted by Amgen Inc. of Thousand Oaks on Monday, March 23, 2009. The guest speaker, Natalie Currie, will present and generate discussion on "The Globalization of Clinical Research."

Speaker:
Natalie Currie is an instructional designer, facilitator and founder of Natalie Currie, Clinical Research Consulting Inc., a learning and development organization dedicated to pharmaceutical and biotechnology industries, clinical research organizations and academic research centers. Harnessing her 17 years of broad based clinical research experience, Natalie is sought after as a speaker and facilitator in the United States and Canada.

Natalie’s breadth of roles has spanned from Clinical Research Coordinator, Clinical Research Associate, Clinical Research Project Manager and management roles in Government and Health Economics. She has worked at the Addiction Research Foundation (now the Centre for Addiction and Mental Health [CAMH]), Janssen-Ortho Inc. (a division of Johnson and Johnson) and has participated on international project teams for pivotal Phase III studies and led Canadian Phase IIIb-IV studies.

Natalie holds an honors life science degree from the University of Toronto and is a member of the Society of Clinical Research Associates, as well as the Canadian and American Societies of Training and Development.

Natalie designs and facilitates engaging, customized corporate and public workshops in the areas of clinical research study management, train-the-trainer and presentation mastery.

Presentation:
Natalie Currie will examine the opportunities and challenges of conducting clinical trials in a global environment. In addition, she will discuss the ethical, regulatory and practical considerations of conducting trials in emerging countries and will explore what might lie ahead for clinical trials in North America.

Admission:
There is no cost to attend this event. Due to security reasons, you must either be an Amgen employee or be accompanied by an Amgen employee to attend this event.

Date and Time:
12:00 PM to 1:00 PM on Monday, March 23, 2009

Location:
Amgen Inc.
Building 28, Room 28-B-A3
1 Amgen Center Drive
Thousand Oaks, CA 91320

Parking is available in the main parking lot which is located at the intersection of Amgen Center Drive and Pauling Drive.

Agenda:
1. 12:00 PM – 12:05 PM Registration
2. 12:05 PM – 12:10 PM Welcome and Introduction
3. 12:10 PM – 12:50 PM The Globalization of Clinical Research
4. 12:50 PM – 12:55 PM Questions and Answers
5. 12:55PM – 1:00 PM Concluding Remarks
6. 1:00PM – 1:30 PM Networking

One Continuing Education (CE) credit will be given to SoCRA members for attending this meeting.
For more information about this meeting, please contact the Chapter Chairperson:
Ana Sharma, MPH, CCRP
Compliance Manager
Research and Development Compliance
Amgen Inc.
Telephone: 805.313.6264
E-mail: arsharma@amgen.com

Please share this announcement with your colleagues.

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Colorado SoCRA Chapter News

Dear Colleagues,

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: March 17, 2010

Time: 12:00-1:00 PM

Agenda: Cord Blood Transplant
(1 SoCRA CEU) will be offered.

Speaker:
Jonathan Gutman, MD

Location: University of Colorado Denver, Anschutz Campus, Rocky Mountain Lions Eye Institute (RMLEI), room 3008

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 Rachel Wood, Rachel.wood@ucdenver.edu

Area map and Fitzsimons campus map

Area Map

Fitzsimons Campus Map

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Connecticut SoCRA Chapter News 

Society of Clinical Research Associates (SoCRA) Connecticut Chapter Meeting

Wednesday, October 1, 2008

  • 5:00 - 5:30 PM Registration & Light Supper Provided
  • 5:30 - 6:30 PM Presentation & Discussion

Connecticut Children’s Medical Center
282 Washington Street
Hartford, CT
Conference Room D, Garden Level

Featured Speaker and Topic:
Sarah Kiskaddon, JD
Vice Chair, Institutional Review Board
Connecticut Children’s Medical Center

Improving the Informed Consent Process: A Guide for Investigators in Developing Materials and Presenting Information to Parents and Children

Jointly sponsored by: Connecticut Children’s Medical Center, Hartford Hospital and the Society of Clinical Research Associates

Please RSVP to Bertha Robbins, RNC, CCRP at brobbin@ccmckids.org by September 26th. Members and non-members are welcome.

*1 Continuing Education Credit hour for SoCRA CCRP Renewal will be awarded.

Please share this announcement with your colleagues.

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Crossroads SoCRA Chapter News - Indiana/Ohio/Kentucky/Illinois

The Crossroads Chapter of SoCRA presents: The Prevention and Resolution of Compliance Issues – a CRA Perspective

Presented by:
David Finch, CCRP
Senior Clinical Research Associate
Quintiles, Incorporated

Tuesday, January 20, 2009

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

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

Indiana University Cancer Pavilion (RT) 101
535 Barnhill Drive
Indianapolis, IN 46202

Parking is available for a fee in both the parking garages south of Michigan Street on Barnhill Drive.

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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Florida (Central) SoCRA Chapter News 

The Central Florida Chapter
M D Anderson Cancer Center Orlando
in conjunction with Winnie Palmer Hospital
83 W. Miller St., Orlando, FL 32806
Is hosting a chapter meeting at:

Winnie Palmer Hospital for Women & Babies
83 W. Miller St.
Orlando, FL 32806
www.Winniepalmerhospital.com

Valet parking available at $5.00
(Valet parking is recommended since space is very limited)

DATE: July 29, 2009

9:00 – 9:30 Registration, Welcome & Updates

9:30 – 10:30 Mildred Beam, Esq.
Vice President-General Counsel, Orlando Health
Ms. Beam will discuss how she structures her determinations when a regulatory situation arises, her process of how she interprets the regulations and state statues for consideration prior to reaching a final decision.

10:30 – 10:45 Break

10:45 – 12:15 Panel 1 - Budgets, Billing & Contracts
Moderator, Allisun Feazell, Manger, CIP, CCRP
Office of Protocol Regulations, MDACCO
Meghan Cadwell, MPH, Project Coordinator, MDACCO
Sally Hewitt, RN, CCRC, Research Manager, Orlando Heart
Tanya Dorisca, MBA, DA, Director of Research Administration,
Global Clinical Research Management, Inc., Orlando, FL

12:15 – 1:30 Lunch (Winnie Palmer has a wonderful cafeteria with a wide selection of entrées)

1:30 – 3:00 Panel 2: How research is managed among diverse settings
Moderator, Allisun Feazell, Manger, CIP, CCRP
Office of Protocol Regulations, MDACCO
Joseph Charles, MPH, Project Coordinator, MDACCO
Tara Roberts, Supervisor, Regulatory & Compliance, Orlando Health
Matty Culbreth, RN, BSN, CCRC, Director of Clinical Trials, Global Clinical Research Management, Inc., Orlando, FL
Merna R. Feygelman, RN, BSN, CCRA, Site Manager, Wyeth Research

There is no fee for this program 4 SoCRA continuing education credit hours have been 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.

Please RSVP by email to Lorraine Hickson, CCRP at Lorraine.hickson@orlandohealth.com

Please share this announcement with your colleagues.

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Florida (South) SoCRA Chapter News 

Invitation to Healthcare Professions Interested in Clinical Research

We are pleased to announce the first educational seminar hosted by the South Florida Chapter of The Society of Clinical Research Associates (SoCRA):

Date: Wednesday, March 23, 2005

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

Location:
University of Miami School of Medicine Diabetes Research Institute
1450 NW 10th Ave
Conference Rm. 6012
Miami, Florida 33136

Topic: Research Methods In Clinical Trials: From The Bench To The Bedside

Guest Lecturer: Aurea M. Flores, Ph.D., University of Miami

Refreshments will be served.

One-hour of Continuing Education Credit is available. Seating is limited.

Please RSVP by March 18, 2005

Contact:
Franciene Coleman, MPH, CCRP, Chapter Chair
University of Miami/ Sylvester Cancer Center
1550 NW 10th Ave.
Fox Bldg
RM 503
Miami, FL 33136

Telephone: 305-243-6823

E-mail: fcoleman@med.miami.edu

***There is no cost involved to attend this lecture.

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Georgia SoCRA Chapter News 

Date: May 16, 2009

Time: 10:00 - Noon

Place:
Cross Creek Cafe
1221 Cross Creek Parkway
Atlanta, Georgia 30327

Topic: Increasing Minority Participation in Clinical Trials

(The restaurant will collect a $10 cover charge from all attendees and brunch will be served.)

Presenter: Dr. Nicole Forman
Medical Director, Pediatrics
Sciele Pharma

Speakers Bio:
Dr. Nicole D. Forman received her Doctor of Medicine from the University of Alabama School of Medicine, Birmingham, AL. She completed her Intern and Residency in Pediatrics at Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY. She completed her Intern and Residency in Pediatrics at Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY. She has served as Medical Science Liaison in Cardiovascular & Metabolism for Novartis Pharmaceuticals and Vice President and Associate Medical Director of Medical Strategy and Clinical Affairs of Lab9 at Cline Davis and Mann. Currently, Dr. Forman serves as the Medical Director of Pediatrics for Sciele Pharmaceuticals in Atlanta Georgia and we are honored to have her as our guest speaker.

Please share meeting date and time with your colleagues.

Sarah Wilson, MS, CCRP
Chairperson Georgia SOCRA Chapter
Phone: 1- 877-847-2186

Lisa Larry-White
Membership & Program Chairperson

Sharon Hyland
Facility Chairperson

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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: A MONITOR’S PERSPECTIVE: “SOURCE DOCUMENTATION”

December 8, 2008 - 1200 to 1315 PM
Room 6015

Halifax Infirmary
1796 Summer Street
Halifax, NS

QEII Health Sciences Centre

1200 NOON – Chapter Update

1215 – 1315 – Presentation Start

Guest Speaker:
Mary-Gordon MacKenzie, BSc; MSc; PhD
Senior Clinical Research Associate
Eli Lilly Canada Inc.
Halifax, Nova Scotia

Please rsvp to:
Sue Moore,CCRP or Lisa Julien,RN, BScN,CCRP
Co-chair, Halifax SoCRA Chapter
Co-Chair, Halifax SoCRA Chapter

Sue.Moore@cdha.nshealth.ca
Lisa.Julien@cdha.nshealth.ca

(902) 473-4128
(902)473-7883

Halifax Infirmary:
Halifax Nova Scotia
1796 Summer Street
ROOM 6015 Classroom - 6th Floor – behind elevators across from 6.2

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Illinois - Chicago Area SoCRA Chapter News

Dear Colleague:

The CHICAGO AREA SOCRA CHAPTER Presents a SEMINAR:
Topic: Good Clinical Practice (GCP)

Speaker:
Jean-Luc De Bouver
Clinical Research & DeveloPMent Training Manager
GlaxoSmithkline, Biologicals

Date: Wednesday, May 19, 2004

Time: 1:15 - 4:30 PM

Location:
Four Seasons - Ground Floor
Advocate Christ Medical Center
4440 West 95th Street
Oak Lawn, Illinois

Local Chapter Business meeting will follow the presentation.
4:30 - 5:00 PM

Nominations are being taken for the Local Chapter Chairperson. Please submit your Name (SoCRA members), Title, Institution, SOCRA background and research experience by May 7, 2004 to Rosemarie Schubert at e-mail address below. Volunteers are also needed to serve on the Education Committee. A candidate roster will be generated and forwarded via e-mail by May 14, 2004. Elections for the Local Chapter Chairperson will be held at the May 19, 2004 Business Meeting.

Please RSVP to:
Rosemarie Schubert, R.H.I.T CTR
Advocate Christ Medical Center
By May12, 2004
Rosemarie.Schubert@advocatehealth.com
(708) 346-4603

Or for any other questions:
Diane Braun, RN CCRP
Advocate Christ Medical Center
(708) 346-4209
diane.braun@advocatehealth.com

Cafeteria nearby for refreshments.

1 CE credit hour is available for SoCRA Certified Professionals

Please join us in this seminar on these very important topics and become acquainted with your research colleagues in the Chicago area SoCRA Chapter.

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Kingston, Ontario Canada SoCRA Chapter News

When: Thursday September 27, 2007

Where: KGH Shea Conference Rm., Burr 1, Rm: 21-1061

Time: 6:30 PM to 7:30 PM

Guest Speaker:
Chris Gray
Coordinator of Investigational Drug Service - KGH

Please RSVP:
Lesley MacPhail at macphail@kgh.kari.net or (613) 549-6666 ext. 3834

SoCRA CE credit: 1.0

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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: March 22, 2010

Cost: No Cost

Presentation: 5:45 p.m. – 7:45 p.m. (two hours of CE)

Facilitator: Anne N. Martien, MBA, CCRP, CRCP, MD SOCRA Chapter Chairperson

Topic: We will be watching a DVD called “FACE-OFF”. It is a mock subject injury trail based on the facts of a real case and recorded at a MAGI conference. Alan Milstein and Fred Rom, world famous attorneys who were the actual plaintiff and defense lawyers, argue this mock clinical trial subject injury case on the DVD. There will be a discussion period afterward.

Location:
Enoch Pratt Free Library
1251 Light Street
Baltimore, MD 21230
Ph: 410-396-1096
Please note that food and beverages are not allowed.

Parking:
There is parking on the street and at the nearby West Street Parking Garage.

SoCRA CEU Credit: 2.0 hours of CE is available for SoCRA members.
Certificates of attendance will be provided.

RSVP: Anne N. Martien, MBA, CCRP
Chapter Chairperson
E-mail: MDSocra@yahoo.com
Cell: 410-570-9812

Limit:
30 participants (room capacity) so please RSVP
If you have RSVP’d, but will not be able to attend, please call the Chapter Chairperson so that she may call the next name on the waiting list.

Registrar Request:
An amiable SOCRA member willing to help attendees sign in and fill out a nametag would be greatly appreciated. Should you wish to help in this capacity, please call or e-mail Anne Martien.

Please share this announcement with your colleagues.

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Massachusetts SoCRA Chapter News

MEETING ANNOUNCEMENT

DATE:
February 17, 2010

TIME:
5:00 PM - 6:00 PM

LOCATION:
Dana-Farber Cancer Institute
DFCI Red Sox Conference Room
3rd Floor, 20 Overland Street
Boston MA 02115

SPEAKER: Amanda Hammond, JD, Deputy Director, Office of Human Research Studies, Dana-Farber Cancer Institute

TOPIC: Data and Safety Monitoring Plans and Boards: NCI Requirements and IRB Responsibilities

OVERVIEW:

  • Background and general principles of Data and Safety Monitoring
  • Roles & Responsibilities of Investigators, Institutions, IRBs, DSMBs
  • Example of Institutional Approach (DF/HCC)
  • References/Resources

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, MPH CCRP 617-632-3731or adellacroce@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 Southeast (SEMN) SoCRA Chapter News (MN/WI/IA)

SEMN SoCRA Chapter meetings for February

Thursday, March 4

  • 5:00 - 5:30 PM Gathering/Networking
  • 5:30 - 6:30 PM Linda S. Knowlton, AA, CCRP
    Assistant Project Manager/Lead Audit Coordinator
    Coalition of Cancer Cooperative Groups

Title: “Informed Consents: It’s Elementary”

Objectives:

  • Define which elements in a consent form are required, additional, or suggested
  • Review proposed change regarding the clinical trial registry bank and the FDA’s change about obtaining and documenting of the informed consent process
  • Discuss the obtaining/documenting informed consent for non-English speaking participants

1 CEU offered

Location: Geffen Auditorium, Subway level of the Gonda Building, Mayo Campus downtown

Parking is available at City and Mayo ramps

No RSVP required

Inquiries can be directed to Teresa Zais at zais.teresa@mayo.edu

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Midwest Regional SoCRA Chapter News (Missouri)

Colleen Kilbourne-Glynn
Project Manager
Washington University School of Medicine
Pediatrics/ PORU/ CB 8519
4444 Forest Park Blvd.
St. Louis MO 63108
Phone: (314) 286-1180
Fax: (314) 286-1185
Email: kilbourne-glenn_C@kids.wustl.edu

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Mubai, India (Maharashtra) SoCRA Chapter News - All India

All India Chapter, SoCRA

The first meeting of the SoCRA All India Chapter will be held:

Sunday 21st December 2008
10 AM – 3 PM

Location:
G-12, Ground Floor, Ruia College
Matunga east, Mumbai
400019, India

Speakers:

1. Dr. Dilip Pawar. MD. - Chief Operating Officer, Akela Pharma, Mumbai, India.

Presentation Title: Future of Clinical Trial Monitoring

Summary: Clinical Trial monitoring is of utmost importance in clinical research. Monitoring involves interaction of investigators with sponsors’ team. Improper monitoring might cause build of lot of quires and can prolong the timelines of clinical trial subsequently leading to increasing cost. This presentation will focus on monitoring importance in coming era of e-technology.

2. Dr. Shirish Sherlekar MD. - Head Life Science Practice. Tata Consultancy Services, Mumbai, India.

Presentation Title: Clinical Research Outsourcing trends: Current and Future

Summary: India is one of the top destinations for outsourcing clinical research. India currently offers advantages in the area of English speaking western trained medical and para medical professionals, software skills, treatment naïve patients, economic clinical trials. Will these points support India as a destination for clinical research in next decade?

Contact:

Dr. Vaidehi Limaye.
All India Chapter, SoCRA.
+91 9820506932
+919820345616

Email: socraindia@yahoo.com

This program will offer 2.0 SoCRA Continuing Education Units.

SoCRA Chapter meetings are free to SoCRA members and nonmembers.

Please share this announcement with your colleagues.

All India SoCRA Chapter is a forum for anyone interested or working in clinical research. We conduct regular interactions and meetings through this chapter.

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

The SoCRA Central Plains Area Chapter
In conjunction with the University of Nebraska Medical Center (UNMC) presents presents a SoCRA Educational Opportunity

Title: Adverse Events, Serious Adverse Events, and Unanticipated Problems--What really needs to be reported to the IRB?

Guest Speaker:
Lisa Korcuska, MS, CIP
Director of Research Compliance
Sanford Health - MeritCare
Sioux Falls, SD
KORUSKL@Sanfordhealth.org

When:
Thursday, March 18, 2010
12:00 – 1:00 PM

Where:

Sanford USD Medical Center, Sioux Falls, SD
Location: Meeting Room C

Videoconference site: UNMC
Omaha, NE
Location: Sorrell Center for Health Sciences 2018

See directions below for both facilities.

Objectives:

  • The learner will be able to define and identify an Unanticipated Problem Involving Risks to Participants or Others.
  • The learner will become familiar with and interpret their own Institutional Review Boards policy on Unanticipated Problems Involving Risks to Participants or Others.

Teleconferencing may be available upon request. RSVP – 3 days in advance.

Please email Chapter Chairperson if interested.
amykeyes@creighton.edu

In an effort to be “Green,” program materials will be provided electronically upon request (before or after presentation). Please email amykeyes@creighton.edu.

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 members.

Directions to University of Nebraska Medical Center, Sorrell Center for Health Sciences:

  • Located on the NE corner of 42nd and Emile.
  • Public parking is available in the Orange flagged parking area.

Directions to Sanford USD Medical Center: 1305 W 18th Street, Sioux Falls, SD 57104

Meeting Room C:

  1. Enter the hospital through the Main Lobby
  2. Take the elevator in the lobby to the Lower Level
  3. Exit the elevator and proceed toward the Schroeder Auditorium
  4. Once in the Atrium of the Schroeder Auditorium
  5. Proceed down the South hallway to room marked Meeting Room C

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New Mexico SoCRA Chapter News

Date: Wednesday, January 13, 2010

Time: 6-7:00 PM

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

Guest Lecturer:
Herbert Davis, PhD
LCF Research
Albuquerque, NM

Topic: Things your Statistics Professor Didn’t Tell You: How to Apply Statistics to Research

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

One hour of SoCRA Continuing Education Credit is available.

Directions:

Approaching from the west of the Gibson campus or from I-25: Exit on Gibson Blvd East. Travel approximately 2½ miles past San Mateo. Drive to the east side of the Gibson campus to the light at Valencia. Turn right into the Gibson parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the building. The West Classroom is left of the auditorium.

Approaching from the east of the Gibson campus: From the intersection of San Pedro and Gibson travel west approximately 2 blocks to the light at Valencia. Turn left into the Gibson parking lot. The Education Building is located at the corner of Gibson and Valencia. Enter the building. The West Classroom is located to the left of the auditorium.

Contact:
Ann Von Worley, RN, BS, CCRP
Clinical Research Associate
Gibson Clinic Foundation
2309 Renard Pl SE Suite 103
Albuquerque, NM 87106
505-262-7569
505-262-7560 (fax)
ann@LCFresearch.org

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New York Hudson Valley SoCRA Chapter News

New York Hudson Valley SOCRA Chapter - Southern NY/New Jersey Meeting

Date: December 10, 2009

7:00 – 8:00 PM Presentations with 1 CE

5:30 – 6:45 PM Optional Networking/Dinner (see details below)

We are pleased to announce our end-of-the-year chapter meeting. The New York Hudson Valley SoCRA chapter targets all clinical research professionals in the Southern region of New York (Manhattan, the Bronx, Queens, Brooklyn and Staten Island) including Westchester, Rockland, Orange, Putnam, Dutchess and Ulster Counties and our neighboring state, New Jersey.

Cost: Free admission to the Presentation (open to SoCRA members and non-members)

Presentation: 7:00 p.m. – 8:00 p.m. – Chapter offers one hour of CE for SoCRA members. Attendance will be recorded and a Certificate of Attendance will be provided

Location:
Yonkers Riverfront Public Library
One Larkin Center, Conference Room 2B, 2nd Floor
Yonkers, NY 10701 (across the street from the Metro North Train Station)

Please ask for the “SoCRA Clinical Research/Clinical Trials Meeting” when you arrive to be directed appropriately.

www.ypl.org/riverfront

Speakers and Topics:

1.
Kristin Fallon-Hanley, BS, MBA, CCRP, is a Clinical Research Coordinator, in the Gynecologic Medical Oncology Service, Department of Medicine at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City. Ms. Fallon-Hanley has worked at MSKCC for the past 8 years, and she gained expertise in clinical trials by working in her current role for the past 6 years. Ms. Fallon-Hanley received her MBA in Healthcare Administration from Baruch-Mount Sinai School of Medicine and graduated Summa Cum Laude. She became certified as CCRP by SoCRA in 2008, obtained her B.S degree in Management (with Honors) from SUNY Binghamton and a Certificate of Culinary Arts (High Honors) from the Institute of Culinary Education in New York.

The topic of her research presentation is as follows:
“Implementing Clinical Trials: Important Factors to Consider in Protocol Design, Tracking Study Patients, Data Collection and Managing Research Staff.”

2.
Kristin Herman, BA, IES, CCRP, is the Research Manager of the Department of Neuro-Oncology at Memorial Sloan-Kettering Cancer Center (MSKCC). She has worked at MSKCC for the past 7 years, spending the past 5 years in clinical research. Her clinical research experience has spanned many departments within the institution, including the departments of medicine, surgery, and neurology. This varied inter-departmental exposure has given her a unique perspective on cross-departmental communication challenges throughout the institution and specifically within clinical research. In addition to managing the clinical research efforts of the neuro-oncology program, Ms. Herman is currently involved in two institutionally supported working groups: the first to assess institution-wide clinical research budget development; and the second is the focus of her presentation on the development and roll-out of a clinical research advisory council. Ms. Herman received her B.A. degree in Spanish minor in Biology from the University of Rochester and received an IES (International Education of Students) from La Universidad Compultense de Madrid. Ms. Herman became certified as CCRP by SoCRA in 2008.

The topic of her presentation is as follows:
“From cracks to CRAC: The Development of a Clinical Research Advisory Council”

“Optional” Networking and Dinner:

5:30 p.m. – 6:45 p.m. (must call or e-mail by December 5th to confirm attendance at dinner: 845-458-4545 or choward-century@slchospital.org) Seating is limited to only10 people for 1 reserved table. If attending dinner: After dinner, we will all walk a short distance from the waterfront, under the railroad trestle, to the presentation at the Library.

“Xaviers X20 on the Hudson”(located behind the Metro North Yonkers Train Station “Hudson Line Train,” which is right on the waterfront by the “New York Water Taxi”)

Restaurant Address: 71 Water Grant Street, Yonkers, NY 10701

Reservation under the name “Century” table of 10

Note: Dinner is optional. Food or beverages at the attendee’s expense

The menu at X20 incorporates classic French technique with Italian and Spanish influences, and Asian embellishments which create a wholly original cuisine unique to the Hudson Valley. X2O’s Main Dining Salon's 25 foot vaulted ceiling and 3 walls of glass frame offers views of the George Washington and Tappan Zee Bridges, as well as sunsets over the Palisades.

Please go to the restaurant’s website for directions and menus.
www.xaviars.com/yonkers/contact.html

Directions:

By Train: Metro-North Train “Hudson Line” (to Yonkers, New York) Frequent trains from Grand Central Terminal to Yonkers (4:54 PM train arrives in Yonkers at 5:25 PM. Train leaves from NYC at 5:20 PM, 5:22 PM and runs about every 15 to 30 minutes). Train from Poughkeepsie leaves at 3:40 and must transfer to arrive in Yonkers at 5:31 PM. For more information on train schedules and fares, contact: 212-532-4900 or www.mta.info

Amtrak also stops at the Yonkers station. Contact: 800-872-7245

By Bus: Express Bus (Bee-Line) from Manhattan. Other buses to Yonkers contact: Westchester County Bus 914-813-7777

By Car: for travel directions see the X2O website www.xaviars.com/yonkers/directions.html or the Yonkers Riverfront Public Library website: www.ypl.org/riverfront

Parking: There is parking on the street (must pay by meter) around the restaurant and the library. A Parking Garage is located near the station.

RSVP:
Crystal Howard-Century, BS, MA, MS, EdD (candidate)
Chapter Co-Chairperson
E-mail: choward-century@slchospital.org
Phone: 845-458-4545

Limit: 20 participants (room capacity) so please RSVP by December 5th

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New York State SoCRA Chapter News

New York State SoCRA Chapter Education Program Announcement

Saturday, May 9, 2009
Gaylord Meeting Hall
Research Studies Center
Roswell Park Cancer Institute
Buffalo, NY 14203

“FDA Inspection – Uncovering the Mystery”
Kim Downing, Consumer Safety Officer
Food and Drug Administration
New York District/Buffalo Office

“Notes to File - An Auditor’s Perspective”
Lorrie D. Divers, CCRP, Director, Clinical Trials Quality Assurance
ACM Global Central Laboratory

"Perceived Change in Nursing Practice Post Implementation of an Electronic Medical Record in a National Comprehensive Cancer Network."
Louise Zielinski, MS, BSN, RN, CCRP, Clinical Research Coordinator II
Roswell Park Cancer Institute

Catering Fee: $25.00
(This fee will cover cost of food and beverages; Parking not included, parking in Roswell Lot is $6.00)

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

Return this form and check payable to caterer “DoubleTree” by April 30, 2009 to:
Virginia Doran, BS, CCRP
Roswell Park Cancer Institute
Clinical Research Services ASB K-106A
Elm & Carlton Streets
Buffalo, New York 14263

~ SoCRA continuing education= 6.0 credit hours ~

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North Carolina (East) SoCRA Chapter News

Greetings,

The March 2010, 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, 1 March, 2010 at Durham Technical Community College (DTCC), Durham, from 6:00 to 7:00 PM. The meeting will be held in the Multi-Purpose Room of the Phail Wynn Jr. Student Services Center.

This month's meeting will feature Ms. Olga Deyneka, Clinical Research Associate, Health Decisions. She will be speaking on "Adverse Event Reporting to IRBs - Improving Human Subject Protection"

OUR TOPIC: Adverse Event Reporting to IRBs - Improving Human Subject Protection

SPEAKER: Olga Deyneka, Clinical Research Associate II, Health Decisions, Inc.

SUMMARY:
Ms. Deyneka's presentation will focus on Safety Management in Clinical Trials as it relates to the new Guidance for Clinical Investigators, Sponsors, and IRBs -- Adverse Event Reporting to IRBs – Improving Human Subject Protection, published in January 2009. As much as any aspect of clinical trials regulation, safety reporting principles and requirements have been in a state of evolution through the last decade. For clinical investigations on drug and biological products conducted under an IND application (Part 312), information about adverse events must be communicated among PIs, sponsors, and IRB. A critical question is: what adverse events should be considered unanticipated problems that merit reporting to an IRB. The practice of local investigators reporting individual, unanalyzed events to IRBs, including IND Safety reports – often with limited information and NO explanation of how the event represents an unanticipated problem – has led to the submission of large numbers of reports to IRBs that are uninformative. IRBs have expressed concerns that the way in which PIs and sponsors typically interpret regulatory requirements to inform IRBs of all “unanticipated problems” does not yield information that is useful to IRBs and thus delays their ability to ensure the protection of human subjects. The FDA recommends that there be careful consideration of whether an AE is an unanticipated problem that must be reported to IRBs. It (FDA) recognizes that for multi-center studies, the Sponsor is in a better position to process and analyze AE data for the entire trial and to assess whether an AE occurrence is both unanticipated and a problem for the study.

Upon completion of this presentation the participants will:

  • Identify Regulatory Requirements and Reporting processes
  • Learn how to Determine If an AE is an Unanticipated Problem that needs to be reported
  • Learn how to Report Unanticipated Problems to IRBs

ABOUT OUR SPEAKER:
Ms. Deyneka has been with Health Decisions, Inc. for 5 years where she serves as a Clinical Research Associate II and has worked on various Phase I - IV studies. Ms. Deyneka was trained as a medical doctor (Internal Medicine) in Russia; graduation date summer 1985. She practiced as a family physician in Russia for four years. Therapeutic areas of experience included Oncology, Respiratory, Endocrinology, Cardiology, Neurology, and Nephrology. Following immigration to the US, she completed her associate degree in clinical research trials in 2004 at the Durham Technical Community College. Ms. Deyneka is an ACRP member and has been a Certified Clinical Research Professional since 2006.

CREDIT HOURS: This program offers 1.0 SoCRA CEUs

QUESTIONS:
If you have any questions, please contact: jmarnold@cato.com or at any of the numbers below.

  • Phone (919) 768-1201
  • Fax (919) 361-2290
  • Cell 452-0905

DIRECTIONS TO DURHAM TECHNICAL COMMUNITY COLLEGE
Phail Wynn Jr. Student Services Center

From I 40 (Take 40W from airport or 40E from Chapel Hill)

  1. Take Durham Freeway (Hwy 147) towards Durham (away from RTP)*
  2. Take Briggs Avenue and take a left (look for DTCC sign)*
  3. Cross over overpass and get in far right lane*
  4. Take a right on Lawson

From here, there are 2 locations to park:

Location 1: Across the street from the Wynn Center building (the tall, brick building). This is the main campus parking.

Go to the cross walk and cross Lawson Street. Follow the sidewalk to the Wynn Center. The Multipurpose Room is inside on your left.

Location 2:

Pass “DTCC main campus” on right

  1. Go to stoplight and take left onto Bacon
  2. Take first left onto Cooper (There will be an elementary school on the right)
  3. Just past school, turn right into drive (you will see a sign for DTCC student and faculty parking)
  4. Follow the fence beside the “Newton Building” around to the back to the large parking lot.
  5. From the parking lot, you will follow the sidewalk between the Newton Building (on your left) and the Glaxo Wellcome Technology Center (on your right). You will cross Cooper Street. The Wynn Center is the building right across the street on the left. The Multipurpose Room is inside on your left.

*If coming from Durham towards RTP, take the first Briggs Avenue exit and turn RIGHT. Stay in that right merge lane and turn right onto Lawson. The remaining directions are the same.

A campus map and additional directions are available at www.durhamtech.edu/html/aboutdt/campusmap.htm

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

The Northwest North Carolina SoCRA Chapter is pleased to announce its first meeting of 2008.

Date: January 24, 2008

Time: 12 Noon – 1 PM (bring a bag lunch; vending available)

Location: 2nd floor classroom, OTP Building

Topic: Legally Effective Informed Consent: What it Means and How to Obtain It

Speaker: Cheryl Byers, MHA, CIP

About the Speaker: Ms. Byers is the director of the Wake Forest University School of Medicine IRB. Prior to her current position, she worked with WFUSM in research as a project manager and clinical research manager. Her expertise is in the interpretation of the federal regulations as they pertain to the safety, rights and welfare of human subjects who participate in research. Ms. Byers has been with the Institutional Review Board since December 2003. Prior to her work at WFUSM, Ms. Byers worked for managed care, specifically two health maintenance organizations in North Carolina as a health education specialist and provider relations specialist.

Ms. Byers holds a Bachelor of Science degree in Health Education at East Carolina University and a Master of Health Administration from the University of North Carolina at Charlotte. She is also a certified IRB professional and a member of PRIM&R. She has presented nationally for the Association on Clinical Research Professionals (ACRP), the Society of Clinical Trials (SCT) and SoCRA on topics ranging from academic clinical research, clinical research basics, informed consent, and the use of electronic systems for increased compliance. She has also presented in many additional forums on the impact of the HIPAA Privacy Rule on human subject research.

Directions: Wake Forest University Baptist Medical Center is located in Winston-Salem, NC. WFUBMC employees can take the shuttle to the OTP building via the PTCRC shuttle which runs every half-hour from the Main Tower. If you have a group, you can request a pickup by calling 6-RIDE (6-7433) from an internal phone. All others should contact Angela Kimel at akimel@wfubmc.edu or 336-716-6522 for directions as the OTP building is separate from the main campus.

Once inside the building, take the elevator or stairs to the second floor. At the door on the right (left, if taking the stairs), you may scan a WFUBMC badge or ring the bell to gain entrance. Once inside, the classroom is the last door on the left.

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

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North Central Regional SoCRA Chapter News

North Central Regional SoCRA Chapter presents: Title: "Where the FDA Regulations End and ICH Begins - The Differences and Similarities between the Two in GCP"

This presentation will review the similarities and differences between the FDA regulations and the ICH GCPs and is targeted to investigator sites and the sponsor personnel (CRAs and Study Managers) that work with them.

Learning Objectives:

  • Define what ICH is and what role they play in clinical research
  • Review the ICH Guidelines for Good Clinical Practice (GCP) and how they differ from the FDA regulations
  • Discuss the impact of ICH-GCPs on Investigator sites

Speaker: Paul Below, Clinical Research Consultant

Time and Date: From 4:00 P.M -5:00 P.M on Wednesday April 09, 2008

Location:
University of Minnesota, East Campus
Moos Tower - Room 2-690
515 Delaware Street, S.E.
Minneapolis, MN

SoCRA Continuing Education Credit: 1 hour

All are welcome (SoCRA members and non-members) and this presentation is free of charge to all.

Please RSVP to:
Jessy Thomas
Email: thoma098@umn.edu
Phone: 612-624-2431

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Ohio "Northeast" SoCRA Chapter News

Date: Wednesday November 4, 2009

Time:

  • 5:30 – 7:30 PM
  • 5:30 – Meal and Networking
  • 5:50 – Announcements
  • 6:00 PM – Presentation to begin
  • Approximately 7 PM – Chapter meeting immediately following Presentation-How can you take an active role in your local chapter? Open to all attendees.

Location:
Wolstein Research Building Auditorium
10900 Euclid Avenue
Cleveland, OH 44106
Sponsorship: Cleveland Clinic - C5 Research

Guest Speaker:

  • Kaye Spector; Health and Medical Reporter – The Plain Dealer
  • John Petrich; President of SoCRA

Topic: Clinical Trials – The Patient Perspective

Kaye has been involved in three clinical trials. She will share her personal experiences in being in different types of research trials and why she chose to be a research participant.

Biography of Speaker: Kaye Spector writes about the people employed by Cleveland's health and medical institutions and the communities they create. She also writes the Healthy Cleveland/Vital Signs column. Kaye came to The Plain Dealer in 2000 and has covered local news, disabilities issues, and suburban life. She most recently was an assistant metro editor.

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. Dinner will be provided.

PLEASE RSVP TO
Roseanne Schott schottr@ccf.org

DRIVING DIRECTIONS:

DRIVING DIRECTIONS: Please note that the Euclid area is still under construction and may require additional driving time.

From the East via Interstate 90, exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and watch for the Information Booth at the right.

From the East via Interstate 80 (Ohio Turnpike - From Eastern Ohio and Pennsylvania), Take the Ohio Turnpike to the interchange for I-480 West (Exit 187.) Proceed west on I-480, which merges with I-271 North. Stay north on I-271 then exit at Cedar Road (sharp right turn off exit ramp). Follow Cedar Road westbound toward Cleveland. (Case is about 20-25 minutes from this point.) Where Cedar starts down a steep hill, look for a sign identifying Case Western Reserve University on your right at the corner of Murray Hill Road. Continue down Cedar Road under the bridge and veer to the right at the next light on Martin Luther King Jr. Blvd. Turn right onto Euclid and watch for the Information Booth at the right.

From the West via the Ohio Turnpike (Interstate 80), exit at Exit 142 and follow Interstate 90 east. Shortly after passing the downtown exits, exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and watch for the Information Booth at the right.

From the South via Interstate 71 or Interstate 77, proceed north until I-71 (or I-77) merges with Interstate 90. Take I-90 east then exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and watch for the Information Booth at the right.

Alternate route through downtown Cleveland: Any of the above directions can be altered if desired by taking route 90 into downtown Cleveland and exiting on Chester Avenue. Head east on Chester to Euclid (just past E. 105th st). Turn left onto Euclid and look to the right for the information booth.

For further information on directions, please go to: www.case.edu/visit/map/b25.html

Parking

The parking area on Cornell is the closest parking with the most availability. The rate for parking is approximately $8 - $10. Alternative parking locations would be the Rainbow Garage or Veale Garage on Adelbert Road. For further information on parking locations, please go to: www.case.edu/visit/map/index.html.

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Ohio Valley SoCRA Chapter News

Dear Colleague:

We are pleased to announce the first meeting of the Ohio Valley Chapter of SoCRA, The Society of Clinical Research Associates.

Topic: What to expect in an FDA audit

Sub-Topics:

  • Informed Consent in Pediatrics
  • Good Clinical Practice
  • IRB investigations
  • Investigator Data Audits

Date: Oct 6, 2004 (Wednesday)

Time: 6-7:30 PM

Place: Cincinnati Children's Hospital Medical Center Sabin Auditorium

Speaker: Hugh McClure, FDA Investigator/Bioresearch Monitoring Specialist

Cost: FREE admission Refreshments provided

Please RSVP to Tiffany Losekamp, Chapter Chairperson at 513-759-5128 or Tiffany.Losekamp@cchmc.org

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Oklahoma SoCRA Chapter News

Dear Colleague,

You are invited to our next Oklahoma SoCRA Chapter meeting:

When: Wednesday, June 14th - 11:30 AM -1:00 PM

Where: OUHSC Bird Library – Provost Conference Room #223

Topic: “An Access Data Base Experience”

Presented by: Elaine Reeves, CCRP, Clinical Research Coordinator, Pediatric Hematology Oncology

RSVP to : Christina-Gonzalez@ouhsc.edu

Come see what can be shared about utilizing an Access Data Base for managing patients and IRB info. Elaine has been using her system in various forms for 20+ years and is willing to share some tips with us. Please come and join us and bring those who might be interested.

We will be having a “Chef Salad” pot luck lunch (see list below). If you do not wish to participate in the potluck then feel free to bring your own lunch.

What we have:

  • Large bag lettuce x4
  • Cheese x2
  • 1lb chopped turkey x1
  • 1lb chopped ham x1
  • Tomatoes x1
  • Carrots
  • 6 eggs boiled & sliced/chopped
  • Can black olives chopped
  • Crackers x2
  • 1 sliced red onion
  • Dessert x2
  • Fruit
  • Sprite & Coke
  • Diet Coke x2
  • Lg. bottle Ranch dressing

What we need:

  • 1lb chopped turkey x2
  • shredded cheese x1
  • 2 tomatoes chopped x2
  • 1lb chopped ham x2
  • Broccoli
  • Cauliflower
  • Celery
  • Croutons x2
  • Bacon Bits
  • Dill pickles
  • Plates
  • Forks
  • Diet DP
  • Lg. bottle bleu cheese dressing
  • Napkins
  • Lg. bottle of Italian dressing
  • Cups

Please RSVP’s to Christina Gonzalez at (405) 271-4412 ext. 42551 or email Christina-gonzalez@ouhsc.edu to let us know what you will be bringing or if you are bringing your own lunch. Space limited to 40. Directions are available for those of you not on campus.

1 hr. Continuing Education Credit available

SOCRA is the Society of Clinical Research Associates. Our local chapter is committed to providing education on campus and statewide to those involved in clinical research. Our meetings are held on the 2nd Wednesday of every month. Please feel free to come even if you are not a member of SOCRA. You can find further information about the national SOCRA organization and certification testing at www.socra.org

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Oregon SoCRA Chapter News

“Successful Implementation of Clinical Trials”

Admission:
There is no cost to attend this event.

Date and Time:
Friday, August 28th, 8:30 AM – 3:30 PM

Conference call and Webex information available upon request.

Location:
Welch Allyn, 8500 Creekside Place, Beaverton, OR 97008 – 8500 Large Training Room

Free parking is available at the 8500 and 8300 Creekside Place. Both of these buildings are occupied by Welch Allyn.

CEUs Offered: 6 hours

RSVP: Please RSVP no later than August 14th to Angie Rock (angela.rock@welchallyn.com).

8:30 AM – 9:00 AM – Registration

9:00 AM – 9:15 AM - Welcome & What is a SoCRA member?
Angie Rock, CCRP
Welch Allyn

9:15 AM – 10:00 AM - Recruitment
Lynn Kunkel & Alysia Cox
Oregon Health & Science University

10:00 AM – 10:15 AM - Break

10:15 AM – 11:15 AM - Data Management
Reesa Laws
Kaiser Permanente Center for Health Research

11:15 AM – 12:15 PM - Basic Statistics
Mike Lasarev
Oregon Health & Science University

12:15 PM – 1:30 PM - Lunch Break

(Network with a bag lunch or enjoy various local eateries in walking or driving distance.)

1:30 PM – 2:15 PM - Research Financial Management & Budgeting, What I AM Learning
Barbara Croney, CCRP
Samaritan Health Services, Corvallis, OR

2:15 PM – 2:30 PM - Break

2:30 PM – 3:15 PM - Device Basics
Angie Rock, CCRP
Welch Allyn

3:15 PM – 3:30 PM Closing Comments
Alysia Cox
Oregon Health & Science University

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Ottawa, Ontario Canada SoCRA Chapter News

Wednesday, January 20, 2010
5:00 PM – 6:00 PM

Location: The Ottawa Hospital - Riverside Campus in the Amphitheatre, Lower Level (LL)

Topic: “Conducting Clinical Trials in Tough Economic Times”

The topic will be the Kidney Research Centre’s poster presentation at the annual SoCRA conference held in Nashville Sept. 25th to 27th, , 2009.

This poster presentation will demonstrate how The Kidney Research Centre (KRC) maintained an innovative group of research professionals during an enormous growth spurt in today’s tough economic times. We will detail the obstacles encountered as well as the resolutions developed when moving from an all Registered Nurse (RN) staff to a diverse staff that includes, well educated, non-nursing coordinators, student interns and university students.

Presneted by:
Judy Cheesman, RN, C NephC, CCRP

Room directions: In the main building take the “service” elevator to the SD level, then turn right. Go to the end of the hall, turn left. It is the 1st room on the left.

Parking: On site parking available – hourly rate

1 Continuing Education Credit Hour may be claimed for attendance at this presentation. Certificates of attendance will be available at the completion of the event.

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@ottawahospital.on.ca

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Pennsylvania / Delaware Valley SoCRA Chapter News

The revitalized Pennsylvania/Delaware Valley SoCRA Chapter is pleased to announce its Februray chapter meeting. All are welcome to attend our education program, no membership required: “Monitoring & Preparations for Sponsor Audits for Study Sites”

DATE: Wednesday, February 17th, 2010

TIME: 4:30-5:30 PM

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

Note: the Lankenau Hospital 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.

TOPIC: “Monitoring & Preparations for Sponsor Audits for Study Sites”

FEATURE PRESENTER:
Sheri Kuss, CCRA
*US Clinical Research Unit Senior Training Manager: Sanofi-Aventis

OBJECTIVES:

  • Understand why the sponsor audits clinical investigator sites
  • Learn tips for the preparation, conduct, and follow-up of a sponsor audit.
  • Learn what the hot topics for clinical investigator audits are and how to minimize them.

ABOUT OUR SPEAKERS:
Sheri Kuss, CCRA has over 16 years in the CRO, Pharmaceutical, and Device industry. She has held positions in Clinical Research including CRA, Project management, Operations, and Training as well as positions in Quality Assurance auditing clinical investigators, sponsor personnel/departments, CROs, study documentation, and systems. She has hosted, prepared, and coordinated FDA regulatory inspections at sponsor and clinical investigator sites. Sheri is currently is a Senior Training Manager working within Qualitative Operations at Sanofi-Aventis' US Clinical Research Unit.

CREDIT HOURS: SoCRA members may claim up to 1.0 SoCRA CEUs for SoCRA recertification.

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

QUESTIONS: Chapter Chair Maria Hendricks, MSN, RN, CCRP: hendricksma@mlhs.org

SAVE THE DATE: 2010 UPCOMING MEETING SCHEDULE:

  • March: TBD

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:

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 the Annenberg Conference Building that is located to the left of the Front entrance of the Hospital. To locate Conference parking area, follow the Conference Parking signs and proceed to the back (past parking lot B and the Employee Parking Lot) to the Roof top area indicated as Conference Parking.

Lot A and Lot B Parking: **Charges apply**. Note: Lots A & B parking areas are the closest to the conference center. Parking Lot A, flanks the Annenberg Conference Building. Charges are the responsibility of the attendee.

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Tennessee, Greater Nashville Regional SoCRA Chapter News

States: Middle Tennessee/Greater Nashville, Western Kentucky

Thursday, February 25, 12-1PM

Room 415 Light Hall

Featured Topic:
Writing Abstracts/Developing Posters

Ms. Wujcik will provide learners with the basic tools needed for developing abstracts and posters. Key questions for consideration are: How do I select a topic? What are the parts of an abstract and/or poster? What are the steps involved in developing the abstract/poster?

Speaker:
Debbie Wujcik, RN, PhD.
Director of Clinical Trials at Meharry

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.

Disclosure Statement: All course directors, planners, and speakers indicated no financial relationships to disclose.

Commercial Support: This educational activity received no commercial support.

Members and non-members welcome. Please bring your lunch.

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

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Tennessee, Mid-South SoCRA Chapter News

When: June 10, 2009, 1:30 – 2:30 PM

“Key Elements of Research Compliance”

3.0 CEU SoCRA hours

Location: St. Jude Children’s Research Hospital (SJCRH), Auditorium (Patient Care Center)

  • 8:00 – 8:30 am: Registration and Sign- In (Continental Breakfast)
  • 8:30 am: Welcome
    Nancy West, RN, BSN, CCRP, Chair MidSouth Chapter of SoCRA
  • 8:35 - 9:30 am: HIPAA and Clinical Research
    Morris Landau, JD, Privacy and Security Compliance Officer, Office of Ethics & Compliance, St Jude
  • 9:30 – 10:30 am: Research Misbehavior
    Sharon Post, JD, Chief Compliance Officer, Director, Office of Ethics & Compliance, St. Jude
  • 10:30 – 10:40 am: Break
  • 10:40 – 11:30 am: You’ve Been Warned…Warning Letters From the FDA
    Laura B. Cummins, JD, Manager, Contract Administration Office of Clinical Research, UT Medical Group, Inc.

Everyone welcomed and there is no fee to attend!

Contact Information:

Nancy West: nancy.west@stjude.org or 901.595.6018

Yvette Montague: yavette.montague@stjude.org or 901.595.6018

Driving Direction to SJCRH, Memphis, TN:

Traveling West:

  1. I-40 E into Memphis.
  2. Exit 1B on Danny Thomas Blvd.
  3. Turn right on Alabama Ave.
  4. Turn right on N. Lauderdale.

Traveling East :

  1. I-40 W into Memphis.
  2. Exit 1C on Danny Thomas Blvd.
  3. Turn right on Alabama Ave.
  4. Turn right on N. Lauderdale.

Traveling North:

  1. I-55 N into Memphis.
  2. Exit right onto I-240 W.
  3. Exit I-40 W.
  4. Turn right on Exit IC on Danny Thomas Blvd.
  5. Turn right on Alabama Ave.
  6. Turn right on N. Lauderdale.

Traveling South:

  1. I-55 S to I-40 E.
  2. Exit 1B on Danny Thomas Blvd.
  3. Turn right on Alabama Ave.
  4. Turn right on N. Lauderdale.

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Texas, Greater Houston/Galveston SoCRA Chapter News

Tuesday, March 9th, 10:00AM-12:00PM

Room 069E (near Luby's) on the main Baylor campus

(One Baylor Plaza, Houston, TX 77030)

Featured Speaker and Topic: "Informed Consent Workshop"

Presented by: The Research Compliance Services, Office of Research

Sponsorship: Jointly sponsored by Research Compliance Services of Baylor College of Medicine and the Society of Clinical Research Associates.

Disclosure Statement: All course directors, planners, and speakers indicated no financial relationships to disclose.

Commercial Support: This educational activity received no commercial support.

Members and non-members welcome.

Seating is limited so please RSVP to researchcomplianceservices@bcm.edu

SoCRA has approved this program for 2 continuing education contact hour for members.

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Texas, Greater San Antonio SoCRA Chapter News

SoCRA San Antonio Chapter Meeting CANCELLED
Due to the weather and scheduling conflicts, the San Antonio Chapter Meeting originally scheduled for December 2 at 5:30 PM - 7:00 PM has been postponed.
An announcement with a new date in January will be sent once the meeting is scheduled.

Date: December 2, 2009

Time: 5:30PM-7PM

  • 5:30 PM – Refreshments and Networking
  • 6:00 PM – Presentation “The Informed Consent Process”
  • 7:00 PM – Chapter Meeting (We will be discussing chapter committee position opportunities as well as future meetings and events) - Open to all attendees.

Speaker:
Marianne Tadros, CCRP
Site Manager
Discovery Clinical Trials

Title of the program:
“The Informed Consent Process” -
We will explore the Informed Consent Process as well as some potential pitfalls in obtaining consent. We will also review case reports of informed consent processes to learn GCP policies.

Location of Meeting:
Synergyst Research
10999 I-10W San Antonio Suite 860
San Antonio, TX 78230

Synergyst Research is located on the corner of I-10 and Huebner in the Chase Building. Free visitor parking is located at the front of the building.

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

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

Please RSVP by November 27, 2009!

For more information and to RSVP please contact the San Antonio Chapter Chair:
Marianne Tadros
210-447-2084
SA.SoCRA@gmail.com

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Texas, West SoCRA Chapter News

February 9 , 2010

12:00-1:00 PM CST

TOPIC: Clinical Research Associates and Their Patients: A Multi-Faceted Relationship

SPEAKER:
Susan Hendrick, Ph.D.
Chair, Dept. of Psychology, Texas Tech University
Adjunct Professor, Dept. of Internal Medicine, Division of Oncology/Hematology, Texas Tech University School of Medicine
Professor, Dept. of Human Development and Family Studies, Texas Tech

SUMMARY:
This one-hour in-service presentation will address the formal role relationship between the Clinical Research Associate and the patient and how that role can quickly become more personal and complex. Research and clinical material from the interdisciplinary Close Relationships literature will be used to help the attendees better understand their unique role with patients and families.

OBJECTIVES:

  • Understand that the role expected when beginning as a Clinical Research Associate is not necessarily the role that can emerge.
  • Learn concepts from the Close Relationships literature that will increase understanding of patients, close others, and the dynamics that may emerge, as well as why those dynamics emerge.
  • Learn to differentiate normal psychological distress from psychopathology and how to differentially address the two.
  • Understand the advantages and appropriateness of psychological consultation and referral for study patients and their families.

LOCATIONS:

  • Lubbock – ACB 220 (Academic Classroom Building – located at front of HSC on 4th and Indiana)
  • El Paso – 235
  • Amarillo – 4717
  • Odessa – 1C12

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

Please RSVP by January 18, 2010: terry.fountain@umchealthsystem.com

No food will be provided but attendees may bring their own lunch.

*1 Continuing Education Credit hours for SoCRA CCRP Renewal will be awarded.

Meetings are open to members and non-members.

Please share this announcement with your colleagues.

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Tokyo, Japan SoCRA Chapter News

JAPAN CHAPTER SEMINAR ANNOUNCEMENT

Japan SoCRA Chapter and NPO CORE are pleased to announce the educational seminar for CRPs on Saturday, March 20, 2010 in Tokyo. Donna Headlee, RN, BSN, CCRP from the United States and past president of SoCRA will be our speaker. Donna will discuss concepts related to developing and adapting SOPs for an effective SOP program. She will use examples from her experiences to illustrate concepts.

Date: Saturday, March 20, 2010

Time: 18:00 - 19:00 (after the CCRP Exam)

Location:

Kitasato University, School of Pharmaceutical Sciences
Room 1202 of the First building, 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:

17:30 - 18:00 Registration

18:00 - 19:00 Lecture and Discussion

Language: Japanese only

CCRP credit: 3.0 CE

Participation fee: free

Japanese information: www.crsu.org/SoCRA_Japan/

Advanced registration: Please email to SoCRAJapan_Committee@umin.ac.jp including your name, affiliation, by March 12, 2010.

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).

Please see the announcement in Japanese.

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Toronto, Canada SoCRA Chapter News (Greater Toronto)

"Ethical Issues in End Of Life Research"

Speaker:
Blair Henry, Ethicist Sunnybrook Health Sciences Centre

Date: Thursday, Feb 25, 2010

Time: 6:00PM-7:30PM

Location:
Princess Margaret Hospital
PMH Auditorium 6-604
610 University Avenue, TO, ON

Please bring your refreshments

RSVP:

susanna.sellmann@uhnresearch.on.ca

biljana.gillmeister@sickkids.ca

If you plan to attend videoconference at CREDIT VALLEY HOSPITAL

Contact: Tabassum Tahir: TZahir@cvh.on.ca

SoCRA CE credit: 1 hour

GTA SoCRA Chapter contact: Susanna Sellmann

Please share this announcement with your colleagues.

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Utah/Idaho SoCRA Chapter News

We are pleased to announce the first meeting of the SoCRA Utah / Idaho Chapter. Please join us for this opportunity for continuing education and professional development.

The Huntsman Cancer Institute and University of Utah IRB has invited the SoCRA Utah / Idaho Chapter to participate in a webinar offered by FDANews

The meeting will be held: March 17, 2010 from 8:30 – 10:30 AM

Huntsman Cancer Institute Auditorium
2000 Circle of Hope, 6th Floor
Salt Lake City, UT 84112

Speaker: Charles H. Pierce, MD, PhD, FCP, CPI

Topic: “Adverse Event Reporting Compliance – The Key to Safe Drug Development.”

A Continuing Education certificate of attendance will be issued to each participant by FDANews.

SoCRA will recognize this program’s attendance certificate for 2 hours of CE credit for SoCRA CCRP (Certified Clinical Research Professional) re-certification requirements.

A Chapter organizational meeting will follow the Webinar to discuss participation/future meetings/venues.

R.S.V.P to: Gina Gregovich via email: gina.gregovich@hci.utah.edu

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Vancouver, Canada SoCRA Chapter News

Vancouver SoCRA Chapter is pleased to announce the 4th Vancouver Island Clinical Research Education Symposium:

Date: Friday, November 27, 2009

Time: 0830-1430

Location:
Royal Jubilee Hospital
Begbie Hall, Woodward Room 124
2192 Richmond Ave, Victoria, BC

Registration:
Please register by November 18, 2009 - seating limited
Email your contact details, position, and affiliation to: Erin Cherban: gcpconsultants@shaw.ca

Presentation Topics and Speakers

8:30-9:00 Registration

9:15-10:00 Health Canada’s Clinical Trial Inspection Program
Sandra Jarvis, MSc, Drug Specialist- Health Canada

10:00-10:15 Health Break

10:15-11:00 Devil is in the Details - Using Technology in Collaborating for Best Practices
Donna Benson, BSc. MA, CCRC, CEO Medical Arts, Health Research Group

11:00-11:45 Globalized Clinical Research Environment Driven By Cost, Speed and Quality
Darren Cowan-Bittner, Regional Team Leader, Pfizer Canada Inc

12:00-1:00 Lunch

13:00-14:30 Optimizing Monitor & Research Coordinator Interactions:

Presentation and Audience Participation
Hannelore Vanetta, CRA
Jodie Chapple, CRA from PRA International
Noreen Lounsbury, BN, CCRC, Manager, Victoria Heart Institute Foundation
Peggy Leonard, RN, CCRC, Vancouver Island Health Authority

**To facilitate discussions, please email Anika Patel (anika.patel@viha.ca) any questions you may have for the speakers by November 18, 2009

Full day attendees will receive 3.75 CE hours toward SoCRA re-certification

Morning presentations will accrue 2.25 CE hours toward SoCRA re-certification

Afternoon presentations will accrue 1.50 CE hours toward SoCRA re-certification

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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)

Wednesday, March 10, 2010

Time:
5:30 PM Meet and Greet
6:00 PM Start of presentation

Presentation: “Reporting of Adverse Events”

Presenter: Maria F. Malone, CCRP

Objectives:

  • The importance of consistent & systematic data collection in clinical trials both within sites, and across multiple sites
  • The methods that result in good data collection
  • How, What, and Where to report the adverse events

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

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."

Room: Desert Center Floor 3E

RSVP: zelle45@aol.com

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:

Note: With ongoing construction of the new Montrose Parkway, the entrance to Kaiser Permanente has moved and is no longer on E. Jefferson. The new 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.

2010 Meeting schedule

  • March 10 Desert Center 3E 5:30 PM
  • April 14 Desert Center 3E 5:30 PM
  • May 12 Desert Center 3E 5:30 PM
  • June 9 Desert Center 3E 5:30 PM
  • July 14 Desert Center 3E 5:30 PM
  • August 11 Desert Center 3E 5:30 PM
  • September 8 Desert Center 3E 5:30 PM
  • October 13 Desert Center 3E 5:30 PM
  • November 10 Desert Center 3E 5:30 PM
  • December 8 Desert Center 3E 5:30 PM

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Wisconsin SoCRA Chapter News

Back to the Basics- IRB, Ethics, and Research Compliance

Date: Saturday September 19, 2009

Place:
Mid-State Technical College
Marshfield Campus
2600 W 5th Street
Marshfield, Wisconsin
www.mstc.edu/marshfield.htm

Please park in the back parking lot. Signs will be posted

Sponsored by:
Aspirus Wausau Hospital
Ray C. Haselby, DO
Mid-State Technical College
Marshfield Clinic Research Foundation

PROGRAM

  • Are Lytic Bacteriophages against Staphylococcus Aureus Found in the Anterior Nares of Humans?
    Vijay H. Aswani, MD, PhD
  • Today's Insider Trading
    Suspect May Wear a Lab Coat
    Nelson Wahlstrom
  • "Adverse Events, Unanticipated Problems,& Anticipated Headaches: An Overview of the New FDA and OHRP Guidances”
    Linda Jaros, B.A CIP
  • “A Day in Clinical Research: A Case Study”
    Ryan Spellecy, Ph. D
  • How informed are you?
    Informed Consent and Health Literacy
    Lori Scheller
  • Genetics and Medicine
    Dr. James Weber

LEARNING OBJECTIVE:

The Attendee should be able to:

  • Recognize how insider trading laws apply to clinical research;
  • Describe An Overview of the New FDA and OHRP Guidances; “Describe Informed Consent and Health Literacy conflicts;
  • and Describe what the ethical issues are between Genetics and Medicine.

FURTHER INFORMATION:

Autumn B Deedon, CCRP
deedon.autumn@mcrf.mfldclin.edu
Phone: 715-389-5001

Mary Spindler LPN, CCRP
spindler.mary@marshfieldclinic.edu
Phone: 715-387-9444

Wendy Foth BS, CCRP
foth.wendy@marshfieldclinic.edu
715-389-4470

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