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Chapter News 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 NewsDate: Thursday, April 18, 2013 Time: 2:00 pm - 3:00 pm Topic: Clinical Trials.gov Registration and Reporting Objectives of the presentation are:
Speakers: CEU: One hour CEU credit is offered for this session for SoCRA members Location: Parking: 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. Arizona (Phoenix) Valley of the Sun SoCRA Chapter NewsThe 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 Location: 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. Speaker: Presentation: Overview of December 2012 FDA Guidance for Industry on Safety Reporting Objectives:
CEC Available: 1 Credit for SoCRA Members. Only SoCRA members will receive a certificate of attendance. Questions: Planning to Attend? Please RSVP: bvolosin@gmail.com Light dinner sponsored by Medix will be provided. Please bring a friend and spread the word! Arkansas SoCRA Chapter NewsThe Arkansas SoCRA Chapter in conjunction with the University of Arkansas for Medical Sciences presents: "ClinicalTrials.gov - How to Register Your Trial" on April 24, 2013 "Developing a Research Protocol" on April 25, 2013 Title: ClinicalTrials.gov - How to Register Your Trial Time: 11:00 am-12:30 pm Locations: University of Arkansas for Medical Sciences - College of Public Health - Room G220 Names and Titles of Speakers: Tracy L. Gatlin Objectives:
Directions and Parking Information: University of Arkansas for Medical Sciences From Interstate 630, take the Pine/Cedar Street Exit. Head north on Pine Street until you reach Markham Street. Turn left onto Markham Street. 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 $0.75 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 CEU's available: 1.5 (for SoCRA members) Questions: Please contact Amy Jenkins (501-686-5939; ajjenkins@uams.edu) or Lyndsey Avery (501-686-5190; lgavery@uams.edu). RSVP: SoCRA members and non-members welcome! Please share this announcement with your colleagues. Title: Developing a Research Protocol Time: 12:00 pm-2:00 pm Locations: University of Arkansas for Medical Sciences - College of Public Health - Room G230 Names and Titles of Speakers: David Avery, CCRP Objectives:
Directions and Parking Information: University of Arkansas for Medical Sciences From Interstate 630, take the Pine/Cedar Street Exit. Head north on Pine Street until you reach Markham Street. Turn left onto Markham Street. 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 $0.75 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 CEU's available: 1.5 (for SoCRA members) Questions: Please contact Amy Jenkins (501-686-5939; ajjenkins@uams.edu) or Lyndsey Avery (501-686-5190; lgavery@uams.edu). RSVP: SoCRA members and non-members welcome! Please share this announcement with your colleagues. Brazil SoCRA Chapter News2nd Brazil SoCRA Chapter Meeting (in conjunction with PharmaDeal) Date: November 27, 2012 Time: 9:00 - 12:00 PM Place: Parking: Rua Casa do Ator, 975 Speaker:
Topic: Objectives:
08:00 - 08:30 08:30 - 09:00 09:00 - 09:45 10:30 - 12:00 CEC Available: Cost: Free admission. (All members and non-members are welcome) Please RSVP to: socra@pharmadeal.com.br Please share this announcement with your colleagues. California (Northern CA) SoCRA Chapter NewsDate: Thursday, May 16, 2013 Time: 12:00 PM - 1:00 PM 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/ Speaker: Judy Stone, MD Blogger, Scientific American Blog Network Topics: The Changing Scene for Physician Investigators Program Objectives: At the conclusion of the program, attendees should be able to:
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) Denise Owensby (Vice Chair) *SoCRA members are credited with 1 SoCRA Continuing Education Unit (CEU). Please share this meeting announcement with your colleagues. California (Orange County) SoCRA Chapter NewsDate: November 9, 2012 Time: 5:45-6:45 pm Topic: Site Management Challenges: A Barrier to Good Clinical Trial Conduct "The challenges encountered in Trial Management include logistical, accountability, and performance issues. These challenges negatively impact clinical trial conduct and run contrary to Good Clinical Practice. If these issues are not appropriately addressed, the sponsor may exercise the discretion to terminate the study which can be costly for the clinical trial center." Speaker: Location: 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 California (San Diego) SoCRA Chapter NewsDate: February 27, 2013 Wednesday Time: 6:00- 7:00 pm Place: Speaker: Brenda Keith RN, MN, AOCNS, Senior Clinical Coordinator, Genentech Topic: The Fundamentals of Cancer
CE: One hour CEU credit is offered for attending this session for SoCRA members. SoCRA members receive Certificates of Attendance RSVP: California (San Francisco Bay Area) SoCRA Chapter NewsDear Colleague, We would like to inform you that the San Fransisco, CA / Bay Area Chapter Chair has stepped down from their position and take this opportunity to reach out to the region to see if anyone is interested in taking over the responsibilities for the Chapter. SoCRA Chapters are intended to offer a forum for members to meet, network and obtain continuing education towards their SoCRA CCRP Certification. We do ask that the chair be CCRP certified for at least two year to ensure they have a good understanding of GCP and SoCRA. If you are interested in this opportunity, please contact me at 800-762 7292 or brent.williamson@socra.org. We can review our policies and the process of operating a chapter with you. There is currently one volunteer who is interested in Co-Chairing the position with another individual. You can learn more about SoCRA Chapters by clicking here. California (Southern/Greater Los Angeles Area) SoCRA Chapter NewsDate: Thursday, May 9, 2013 Time: Noon - 1:00 pm Place: Speakers: Marie Jackson, PhD, MBA Susan Hmwe, MBBS, MSHS, PhD Candidate Topic: "Overview of Good Clinical Practices " Learning Objectives:
Directions: For Directions, please visit: For Parking and Conference Room Location, please visit: Cost: Free admission (all members and non-members are welcome) CE: SoCRA members will be credited with 1.0 Continuing Education Units (CEU) For questions please contact: California (Sylmar) SoCRA Chapter NewsWe are pleased to announce the first kick off meeting for the California (Sylmar) SoCRA Chapter: Date and Time: Thursday, May 16, 2013 from 12:00-1:00 Meeting Location: Speaker: Gretchen began her career in healthcare administration and consulting over 25 years ago. Prior to joining St. Jude Medical 5 years ago, she spent 8 years as a Senior Manager in Healthcare consulting assisting clients with operational improvements and strategic relationships. She also served as VP of Clinical Research and Reimbursement in a medical device start-up company. Gretchen joined St. Jude Medical as a Clinical Study Manager and eventually developed the contracting and payment department at the Neuromodulation Division. She accepted her current position as a Director of Clinical Research Operations for Implantable Electronic Systems Division in November 2012. Presentation Title: Research Seminar Series - "Planning and Negotiating Clinical Study Budgets" Program Objectives:
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 Mariah Tackett at mtackett@sjm.com to RSVP. California (South Bay - LA to San Diego Area) SoCRA Chapter NewsFrom 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 Alicia Martin-Santiago/Research Inquiry Coordinator Tarek Dessouky, M.D.,DIS, MBA, MPH Looking forward to meeting you all! Colorado SoCRA Chapter NewsThe 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: February 16, 2012 Time: 2-3pm. Location: Names of speakers:
Title: Strange Germs, New Plagues, Weird Bacteria... Oh My! Dr. Barron will cover MRSA, flu - seasonal, H1N1, bird flu, West Nile Virus, SARS and TB. Directions and parking information: The campus is located at 1665 Aurora Court, Aurora, CO 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
Connecticut SoCRA Chapter NewsWe are pleased to announce another educational seminar hosted by the Connecticut Chapter of the Society of Clinical Research Associates (SoCRA): Date: Wednesday February 27, 2013, 12:00 - 1 p.m.
Location: Seminar Theme: Budget Development and Negotiation for the Investigative Site Presented by: Brief Description: Learning Objectives:
SoCRA designates this educational activity for a maximum of 1.0 Continuing Education Credits for SoCRA CE. Please RSVP by May 17 to Susanne Morrill, CCRP: smorril@harthosp.org; For more information contact Susanne at 860 545-1588. Please feel free to bring your own lunch, food will not be provided. Florida (Central) SoCRA Chapter NewsWe are pleased to announce the first Central Florida Chapter SoCRA Meeting Saturday February 11, 2012
Covance Clinical Research Unit Speaker: David Subich, M.D. acting medical director- Covance CRU, Daytona Beach Objectives:
Directions: 95 south "Exit 265 toward Holly Hill/Daytona turn right onto Williamson Boulevard/ CR 4009. Turn left onto Mason Avenue/CR-430 plenty of parking-Front entrance look for the Covance sign "off of Fentress Avenue" the entrance door states "Covance East Entrance" CE: SoCRA members will receive one CE credit per hour of presentation which includes 15 minute question and answer session Contact person: Maria F. Malone c: 301-956-6774 RSVP to: mariamalone@rocketmail.com **Only SoCRA members receive Certificates of Attendance. Please share this announcement with your colleagues. SoCRA has sent this email for educational purposes only. Florida (South) SoCRA Chapter NewsDate: February 21, 2013 Time: 6:30 - 8:00 PM Location: Speaker: Topic:
RSVP: Lorraine.hickson@holy-cross.com Parking: Parking available at main hospital CE: 1.5 CEU's available for SoCRA members Florida/Suncoast SoCRA Chapter NewsSoCRA Suncoast Chapter Greetings to all SoCRA members in the Suncoast Chapter area! It is time to plan our quarterly Chapter meeting. April 29, 2012 marked our 2 year Anniversary as a Chapter. In keeping with our Chapter requirements we need to have 2 to 3 meetings before the end of 2012. As you may remember, we have 2 Speakers from the FDA who have agreed to do a 2 hour Educational Program for our Chapter on IND's and NDA's along with the basics on SAE Reporting. This is an outstanding opportunity we do not want to miss. We need to locate and secure a meeting forum that will accommodate seating and parking for up to 50 individuals. The time frame is either the week of July 16 or the week of August 6, in the late afternoon to early evening. I expect this Program to have a large turnout. Over the next 2 weeks I urge all of you to please ask your employer if they would like host our educational program and let me know by June 22. After our next Educational Program we will have a 30 minutes Chapter meeting. Please email me at dmimo@tampabay.rr.com. I look forward to seeing all of you soon. Debra Mimo, RN, CRC, CCRP Please share this announcement with your colleagues. Georgia SoCRA Chapter NewsSaturday, January 15, 2011 Place: Agenda:
Speaker: Topic: Clinical Trial Disclosure Learning Objectives:
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 Great Lakes SoCRA Chapter News - Michigan/Ohio/WisconsinChapter Chairperson: Halifax, Nova Scotia, Canada SoCRA Chapter NewsSoCRA Halifax Chapter Meeting Date: Tuesday October 16, 2012 noon-1pm Time: noon- 1:00 pm Place: Speakers: Mary Kate Needler, Program Manager, Research Quality Topic: Developing & Using Standard Operating Procedures Objectives: What are SOPs, who needs them, and why are they important? Pick up practical tips for developing and using SOPs in your research. One hour CEU credit is offered for attending this session for SoCRA members. **Certificates of Attendance will be issued for SoCRA members only RSVP: Upcoming Meetings:
Idaho SoCRA Chapter NewsTuesday May 28, 2013 Riverside Hotel (ballroom)-2900 Chinden Blvd. Boise Idaho 83714 6:00-7:30 p.m. FDA Regulations Vs. ICH GCP Standards-What does it mean to be GCP Compliant? Mia Gussie, CCRP, CIP, Founder, REACH Research Alliance This session will explore the differences between FDA regulations & ICH GCP standards and the challenges of being a GCP compliant institution Open discussions will be encouraged. Objectives: 6:00-7:00PM To gain an understanding of each regulatory agency and their scope. 7:00-7:30PM SOCRA Members Planning and Organization - Non-SOCRA members will not need to attend There is a meeting preceding the SoCRA Chapter meeting. This event will be held in conjunction with "Accelerating the Commercialization of Research" a presentation sponsored by The CORE. All SoCRA members are welcome to attend. This presentation will be held at the same location and will begin at 4:00pm. Please go to http://www.thecoreidaho.com/ for more detailed information. This presentation is not part of the SoCRA chapter meeting and will not be included with the SoCRA certificate of attendance. Please contact Mia Gussie if you have any questions: mia@reachra.com or 303.921.9188 Hors d'oeuvres will be provided Please share this announcement with your colleagues. Illinois/Indiana/Kentucky/Ohio (Crossroads) Chapter NewsThe Crossroads Chapter of SoCRA presents: The Monitoring Visit Objectives:
Presented by: Date: Wednesday, April 22, 2013 Agenda: Place: Parking: 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. Indiana (South) SoCRA Chapter NewsThe Southern Indiana Chapter of SoCRA presents: "Source Documents Tell The Story" Presented by: November 7, 2012
Place: Cancer Center of Indiana Please RSVP to: Joslin Diabetes Research This program has been awarded 1.5 Continuing Education Unit(CEU) for SoCRA Members. Kingston, Ontario Canada SoCRA Chapter NewsThe Kingston SoCRA Chapter proudly presents: "Business Research in Healthcare" Presenter: Objectives:
Date: Wednesday, May 15, 2013 Time: 11:55 AM - 1:00 PM Location: RSVP: SoCRA members may claim 1 hour of continuing education units (CEC)*** Only SoCRA members recieve Certificates of Attendance Maine SoCRA Chapter NewsThe 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: Maryland SoCRA Chapter NewsBaltimore Area Chapter Date: Wednesday, May 22, 2013 Time:
Location: Location: 720 Rutland Ave, Turner Room: West Room RSVP: Please RSVP to: swehage@gmail.com Presenter: Presentation: Compliance Monitoring Program Manager, Johns Hopkins School of Medicine Learning Objectives: By the end of the lecture, the attendee will be able to:
Credits Available: 1 CE credit for SoCRA members Parking: Park in the Rutland Garage (1800 E. Madison St) See H2 on campus map (below) or visit this weblink. Location: Madison Street at Rutland Avenue Entrances: 1800 Madison Street (there is a covered bridge connected to the hospital, which can be accessed on the 5th floor of the garage. This bridge leads to the 3rd floor of the Carnegie Building. The following rates are applicable in all parking garages on the East Baltimore campus.
Driving Directions: The Johns Hopkins Hospital Park in the Orleans Street Garage. Valet Parking is available at the Hospital's main entrance on Orleans Street; the Outpatient Center (Outpatient Center circle); and the Weinberg Building on Jefferson Street (Sidney Kimmel Cancer Center). From Washington, D.C., Virginia and the I-95 access at BWI Airport Take I-95 North to Exit 53 (I-395 North) into downtown Baltimore. Hospital Parking (Orleans Garage): From Broadway, turn RIGHT onto Orleans Street. From Philadelphia, New York and Northeastern Baltimore Suburbs Take I-95 South to Baltimore; merge onto I-895 South. Hospital Parking (Orleans Garage): Continue on US-40 West/Pulaski Highway (turns into Orleans Street) approximately 3 miles to N. Wolfe Street. From York, Central Pennsylvania and Northern Baltimore Suburbs Take I-83 South into Baltimore. Hospital Parking (Orleans Garage): From Broadway, turn RIGHT onto Orleans Street. From Annapolis and Maryland's Eastern Shore From Route 50, take I-97 toward Baltimore and follow I-97 to the Baltimore Beltway (I-695) toward Towson. Hospital Parking (Orleans Garage): From Broadway, turn RIGHT onto Orleans Street. Frederick and Western Maryland Take I-70 East. Hospital Parking (Orleans Garage): From Broadway, turn RIGHT onto Orleans Street. Please share this announcement with your colleagues. Massachusetts SoCRA Chapter NewsDate: Wednesday, January 30, 2013 Time: 5:00pm- 6:00pm Location: Speaker: Speaker Affiliation: Topic: Navigating the Mobile Tidal Wave in Healthcare Objectives:
Credits: SoCRA members may claim up to one hour of CEU (members may only claim actual time spent in the educational event). Certificates of attendance will be available at the completion of the event for SoCRA members. Questions: Please contact, Alyssa K. Gateman, MPH CCRP 617-632-3731or agateman@partners.org Massachusetts (Western) SoCRA Chapter NewsSoCRA Western Massachusetts Chapter is pleased to announce its first meeting. Date: May 8, 2013 Time: 10:30-11:30 AM Location: Speaker: Topic: Fraud in Research Objectives: By participating in this continuing education program, the attendee should be able to:
All faculty participating in continuing education programs sponsored by Baystate Health are expected to disclose to the program audience any real or apparent conflicts of interest related to the content of their presentation. None of the members of the faculty or planning committee have commercial relationships with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Credits: SoCRA designates this education activity for a maximum of 1.0 Continuing Education Credits for SoCRA Members.. Questions: Michigan - Saginaw Bay Chapter NewsThe 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: Featured Topic: Location: Contact information and R.S.V.P. Michigan (Southeastern) SoCRA Chapter NewsYou are currently invited to the presentation sponsored by the Southeastern Michigan SoCRA Chapter: When: "Improving Efficiency in the Management of Investigator Initiated Multi-Centered Trials in an Academic Setting" Purpose: To improve efficiency by reducing time spent on management of multi-centered clinical trials through the creation of standardized workflow checklists and toolkits Presented by: Melissa Mietzel, MS, CCRP from the University of Michigan Directions: www.med.umich.edu/cvc/pat_vis/around_maps.html All attendants coming from off campus should park at the Taubman Parking Structure - Deck A. The Cardiovascular Center Parking Structure - Deck C is only for CVC patients and/or their families. All others will be redirected to the Taubman Parking Structure - Deck A. RSVP: CTO-SOCRA_chapter@med.umich.edu Members and non-members welcome. SoCRA has approved this program for 1 continuing education contact hour for members. We look forward to seeing you all there! Please share this announcement with your colleagues. Minnesota North Central Regional (Minnesota) SoCRA Chapter NewsLocation: Date and Time: Presenter: Title: Auditing - An Exchange of Information Learning Objectives: At the end of this presentation, attendees should know and understand:
Continuing Education Credits: 1 CE Credit for SoCRA members. Fee: This program is free of charge to all. Please RSVP to: Minnesota Southeast (SEMN) SoCRA Chapter News (MN/WI/IA)The SEMN SoCRA Chapter Meeting on Tuesday, March 19, 2013
Presenter: Title: "Implementing a Successful Research Regulatory Support Program in an Academic Medical Center: It's About Creating the Culture " Objectives:
6:00 - 6:30 pm Annual Conference Take Aways Objectives: Discuss tips, tools, and lessons learned through conference presentations Presenters: 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:
Iowa/Nebraska/South Dakota (Central Plains) SoCRA Chapter NewsThe SoCRA Central Plains Area Chapter presents a SoCRA Educational Opportunity When: Host site: Site Liaisons: Please contact Jenny Kucera at jikucera@unmc.edu or Amy Keyes at amykeyes@creighton.edu for further instructions on joining/attending this live stream meeting. Guest Speakers:
Title: Ethical Guidelines for Contraception in Research Objectives:
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. New Jersey (Northern) SoCRA Chapter NewsThe Northern New Jersey Chapter in conjunction with the John Theurer Cancer Center at Hackensack University Medical Center invites you to the Northern New Jersey Chapter SoCRA Meeting Date: February 15, 2013 Time: 12:00PM-1:15PM Location: JTCC's George and June Croonquist Conference Room (Room 1) Topic: "Drug Development in 2013" Speaker: Program Objectives: At the conclusion of the program, attendees should be able to:
Free Admission- All SoCRA members and non-members are welcome* *SoCRA members receive up to 1 hour of SoCRA Continuing Education Credit RSVP: Claire Dimler (201.996.5834) Please share this announcement with your colleagues. New Mexico SoCRA Chapter NewsDate: Wed., April 10, 2013 Time: 6-7:00pm Location: Guest Lecturer: Topic: The Changing Landscape in Clinical Research Accelerated by Digital Technologies Overview of talk: A unified technology platform is replacing the long-standing approach of conducting paper-based clinical studies. The benefit appears to extend to all stakeholders--sharing information on a real-time basis allowing for better decision making across the board from early-stage planning such as protocol development to regulatory submission and publication of clinical data. Rather than technology assisting in the traditional CRO approach the new model is that technology is streamlining the process for testing new drugs and devices. One of the biggest problems with the old approach is that there are numerous inefficiencies in maintaining a system that is compartmentalized and where there is a lack of transparency and communication. Objectives:
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 2013 Chapter Meetings
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: New York Hudson Valley SoCRA Chapter NewsNew 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:
Thursday, February 16, 2012 - NY Hudson Valley SoCRA Chapter Meeting Presentation Topic &Schedule:
Title of Presentation: Research Seminar Series - "Planning and Preparation for a Clinical Trial" Topic: This Presentation will include slides with discussion followed by an interactive session, which will entail participation by the audience The key learning objectives will be:
About Janet E. Holwell, CCRC, CCRA: Janet began her career as a clinical research coordinator in academia over 30 years ago. Prior to transitioning to industry 13 years ago, she managed the clinical pharmacology unit in dermatology at NY Presbyterian Medical Center - Columbia University, overseeing all operations. She was also an instructor in good clinical practice (GCP) and helped develop the first GCP program in an academic institution while at Columbia. Janet came to Pfizer through the Pharmacia acquisition. Prior to her current position as a Clinical Quality Lead, she held positions as a clinical research associate, territory development specialist, trainer, and regional study lead. She is an active member of the Association of Clinical Research Professionals (ACRP), having served on their board of trustees and various forums. She previous served as co-chair of the CRA forum. She was a founding member, past and now current president of the New York Metropolitan Chapter. Accreditation "Continuing Education" for Participation in Janet E. Holwell's 2-hour Presentation - 2 CEU = 2 Contact Hours. The NY Hudson Valley SoCRA Chapter offers Continuing Education (2-CEUs) for SoCRA members who attend this Presentation. Continuing Education Credit will be assigned commensurate with the extent of the SoCRA Attendee's participation in this activity. Attendance will be recorded and a "Certificate of Attendance" will be distributed to "Members" of SoCRA. Location and Address of February 16th Presentation: 757 3rd Avenue, 2nd Floor, Suite 210, Glass Conference Room, Office located between East 47th and 48th Street in the Aerotek Scientific, LLC, New York City Office in proximity to Grand Central Station NY, New York 10017 - *** This Manhattan 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 (see directions below). Cost: "FreeAdmission" to the Presentation (open to all SoCRA Members, Non-members, all Medical, Health and Research Professionals). Must RSVP TO: admin@howard-centuryclinicalresearch.com or 914-573-1710 When arriving for the SoCRA Chapter Meeting/Presentation, please go directly to the 2nd Floor, to Suite 210. The Presentation will be held in the Conference Room of Aerotek Scientific's NYC Office. For assistance regarding the location of the meeting, contact Sarah Jones, CIR: 212-320-8704 or sajones@aerotek.com *** 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 will begin after the networking social. Discussion on chapter activities, future chapter meetings, networking opportunities, sharing career opportunities in Clinical Research, the SoCRA CCRP Certification Exam at New York Hospital Queens on April 6, 2012 and formation of Study Groups for the CCRP exam and attendance at SoCRA National events. Must contact Crystal to RSVP. Please call or e-mail to confirm attendance at lunch: 914-573-1710 or admin@howard-centuryclinicalresearch.com). Directions to February 16th NY Hudson Valley SoCRA Chapter Meeting New York City Location: Office is located in proximity to Grand Central Station. Transportation: By Plane: JFK http://www.panynj.gov/airports/jfk.html LaGuardia Airports (New York) www.panynj.gov/airports/laguardia.html By Train: Metro-North Train, Grand Central Station (Manhattan) New York City. Take Metro North to Grand Central Station *87 East 42nd Street), then can take a taxi from the taxi stand or follow "by bus" or "by foot" instructions. Frequent Metro-North trains from local stops along the Harlem, Hudson and New Haven Connecticut Lines. For more information on train schedules and fares, contact: 212-532-4900 or www.mta.info Path Train from New Jersey to 33rd Street Westside Manhattan: http://www.panynj.gov/port-authority-ny-nj.html near Amtrak, NJ Transit, MTA Subway B/D/F/M/N/Q/R - LIRR, West 33rd Street take a yellow taxi from Taxi Stand or subway, E train from West 34th street to Lexington Avenue/53rd Street, then walk 6 blocks to 757 3rd Ave (between 47th - 48th Street) By Subway: subway E train from Westside of Manhattan at 34th street to Lexington Avenue/East 53rd Street, then walk 6 blocks to 757 3rd Ave (47th Street) or MTA B/D/F/M/N/Q/R for more detailed subway directions call: 212-532-4900 or www.mta.info By Bus: Greyhound, Trailways, Peter Pan, NJ Transit, etc., in the Port Authority Bus Terminal, Westside of Manhattan in Times Square: www.panynj.gov/bus-terminals or contact: 1-800-221-9903 or 212-435-7000 or for Trailways bus http://www.trailwaysny.com/ or call: 800-776-7548. Local NYC BUS: By Bus from Grand Central, take the local M42 Crosstown bus two stops to 3rd Ave and then walk to 757 3rd Ave (47th Street). From Penn Station, walk to West 32nd Street, 7th Avenue and take the Q32 Bus "Jackson HTS Northern-81 via Roosevelt" to Madison Ave, East 47th Street and walk to 757 3rd Avenue By Taxi: There are taxi stands in front of Grand Central Station, Port Authority Bus Terminal, Penn Station or can "flag" a Taxi throughout Manhattan. By "Foot:" From Grand Central Station, head southeast on East 42nd Street toward Park Avenue, walk 5 (long) blocks, then turn left onto 3rd Avenue. Destination will be on the right By Amtrak and Long Island Railroad: Travel from Upstate New York, Albany via Amtrak and those in Long Island, Queens, Brooklyn can take the Long Island Railroad (LIRR) to "Penn Station." Contact Amtrak: 800-872-7245 or www.amtrak.com. LIRR: From Long Island, Queens, Brooklyn www.mta.info/lirr/ to New York Penn Station (West 33rd Street), take a yellow taxi from Taxi Stand or subway, E train from West 34th street to Lexington Avenue/53rd Street, then walk 6 blocks to 757 3rd Ave (between 47th - 48th Street) By Car: this chapter meeting is on the Eastside of Manhattan in proximity to the FDR Drive. For travel directions from Albany, New York City, the Hudson Valley, New Jersey or Connecticut, please enter directions in MapQuest, use a GPS or follow website directions: www.aerotek.com Parking: There is parking on the street (pay by meter) around the office. Parking Garages are located throughout Manhattan. www.quikparkgarages.com/parking_locations.aspx RSVP: Crystal Howard-Century, BS, MA, MS, ABD, EdD (candidate) Please share this announcement with your colleagues. New York State SoCRA Chapter NewsSpring Program Date: Time: Place: Agenda: 8:30-8:50 a.m. Registration 8:50 - 9:00 a.m. Welcome and Introduction: Kathi Durdon, MA, CCRP, SoCRA NYS Chapter Chair, Manager, Clinical Operations, Welch Allyn 9:00 - 10:00 a.m. Informed Consent: Past Present and Future Dr. Gary L Chadwick, PharmD, MPH, CIP, Abstract: Informed consent is a relatively new concept, both in medicine and research. This presentation will trace informed consent from its earliest sprouts in scandal through its current regulatory and social conventions and will end with some speculation about possible future directions. 10:00 - 11:00 a.m. Risk Management in Clinical Trials Abstract: This presentation aims to provide information to clinical research professionals when setting up a risk management (RM) plan. Adapting the Committee of Sponsoring Organizations of the Treadway Commission (COSO) model can help any organization to develop effective control strategies. 11:00 - 12:00 p.m. Humanized SCID Mice: Bridging Bench and Bedside Jennifer F. Moffat, PhD, Associate Professor, Department of Microbiology and Immunology, SUNY Upstate Medical University Abstract: Humanized mouse models are an essential aspect of translational studiesthat bridge medicinal chemistry and vaccine candidates with human clinical trials for new antiviral drugs and vaccines. The NIH has an integrated system, which includes both academic and industry labs, that supports translational projects all the way through FDA approval. 12:00 - 12:45 p.m. Lunch 12:45 - 1:45 p.m. The History of Pediatric ALL: How we have Reached the CurrentSurvival Rates Dr. Andrea Dvorak Abstract: The goal of this talk is to review the research that has led to the good outcomes that we currently have achieved in the treatment of Pediatric Acute Lymphoblastic Leukemia. I will also explore the current research and where the treatment is headed. 1:45 - 2:45 p.m. Nosocomial Infection and Why it is Important to Research Donna Williams, RN, CCRP, Clinical Research Associate, Welch Allyn Abstract: Nosocomial infection is a hot topic today with so much focus on the cost of healthcare and moving patients in and out of a hospitals as soon as possible. Research data supports those decisions. There are many different forms of research involved in this process. Our role as patients, nurses, doctors and research professionals can contribute to the overall outcome if we are aware of the impact. 2:45 - 3:00 p.m. Break 3:00 - 3:30 p.m. Moving from a Clinical Research Hospital Setting to Industry Janice Riley, RN, Clinical Research Associate, Welch Allyn, Syracuse, NY Abstract:A personal look at one nurse's transition from the bedside to clinical research and finally a manufacturing based research setting. The path, the potholes and the payoff. 3:30 - 4:30 p.m. Evidence Based Nursing in Practice at Crouse Hospital Martiel Stoecker RN, CNM, DNP, OB CNS-Crouse Hospital, Michael Allain,RN, CNS, Intensive Care Unit and Emergency Department, Crouse Hospitaland Ellen Owens, RN, BS, MLS, Crouse Hospital Library Abstract: An overview of the history, concepts and process of evidence based nursing. Identification of current strategies for researching studies that have been conducted in controlled circumstances that provide strong evidence to supportpractice decisions. Understanding of how EBN is implemented, evaluated, andsustained at the bedside, with examples in practice at Crouse Hospital. 4:30 - 4:45 p.m. Program Q&A - 15 minutes SoCRA Members may be credited for (up to) 6.75 hours Continuing Education Credit Hours. Each participant should claim only those hours of credit that he/she actually spent in the educational activity. Only SoCRA members will recive SoCRA certificates of attendance. There is no registration fee for this program. Catering Cost (Beverages and Lunch): $40.00 Payable to "Eurest Dining Services" Please send Catering Payment/RSVP directly to Eurest/The Lodge by May 10, 2013* to: Lauren Hoffman *Attendees may send payment for food and beverage by check payable to "Eurest Dining Services" to be received by May 10 (in order to have final count for food) or you can also pay by credit card, please call Lauren at 315-291-3700 Program Contact: Kathi Durdon, 315-685-2637, Kathi.durdon@welchallyn.com Please share this announcement with your colleagues. New York (Western) SoCRA Chapter NewsWestern New York State Chapter Fall Program Date: Saturday, November 12, 2011 Place: Objectives of the program:
CE: SoCRA continuing education = 4.25 credit hours for SoCRA Members Schedule of Events 8:00 am 8:30 -8:45 8:45 - 9:45 9:45 - 10:45 10:45 - 11:00 11:00 - 12:00 11:45 - 12:45 12:45 - 1:00 Program Conclusion Suggested Hotel: Return the form via e-mail by November 07, 2011 to: Please share this announcement with your colleagues. North Carolina (East) SoCRA Chapter NewsThe APRIL 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, 01 April 2012, from 6:00 to 7:00 PM. RTP Location: Quintiles Inc., Bradford Building Wilmington Remote Location: Betty H. Cameron Women's and Children's Hospital (CWCH) Pinehurst Remote Location: FirstHealth of the Carolinas OUR TOPIC: Unblinded Monitoring Programs - Design and Education SPEAKER: Mary K.D. D'Rozario, MSCR, CCRP, RAC, CCRA, President, Clinical Research Performance, Inc. ABSTRACT: Expanded research in biologics and other novel therapies will increase the need for unblinded monitoring programs. This presentation will focus on the management and monitoring of clinical studies which require unblinded site staff and site monitoring. Study design will be discussed with a consideration toward site staffing structures. Appropriate documentation of unblinded staffing delegation, source document requirements, and monitoring considerations will be discussed. Management of unblinded monitoring at the sponsor and CRO will also be reviewed. ABOUT OUR SPEAKER: Mary D'Rozario has a Master's Degree in Clinical Research Organization and Management from Drexel University College of Medicine, is presently an MBA student at NCSU, and holds the designations CCRP, RAC and CCRA. Ms. D'Rozario founded Clinical Research Performance, Inc. after more than 10 years of experience at Contract Research Organizations in data management, site budgets and contracts, site startup, site monitoring, and study management. Clinical Research Performance focuses on providing consulting to physician-owned sites and also provides services to companies developing products for the clinical research industry. -If you have any questions, please contact Mary D'Rozario at mary.drozario@crplink.com or (919) 890-5513. SoCRA members may claim 1.0 CE credit hour. SoCRA members will receive Certificates of Attendance. The RTP SoCRA Chapter Meeting Quintiles, Inc. Bradford Building Rm. 6346 Contact: Mary D'Rozario, (919) 890-5513, mary.drozario@crplink.com Wilmington Remote Site Betty H. Cameron Women's and Children's Hospital (CWCH) just around the corner from the phone: 910.343.2641 email: anne.patterson@nhrmc.org Pinehurst: FirstHealth of the Carolinas North Carolina (Mid Carolina – Charlotte) SoCRA Chapter NewsMid Carolina SoCRA Chapter Meeting Date: Wednesday, March 20, 2013 Time: 6:00 to 7:30 PM Topic: Unblinded Monitoring Programs - Design and Education Objectives of the presentation are:
Speaker: Mary D'Rozario CEU: One hour CEU credit is offered for SoCRA members only Location: Enter the first floor from the parking deck and take the Hemby Elevator (elevator near the cafeteria) to the Ground Floor. Turn left out of the elevator and the multipurpose room will be in front of you. Parking: Enter Visitor's Parking Garage from Hawthorne Lane Left of Presbyterian Hospital front. Parking is Free Cost: Free admission. All members and non-members welcome RSVP:
Information:
North Carolina (Winston-Salem/Northwest) SoCRA Chapter NewsThe Northwest NC (Winston-Salem) SoCRA Chapter is pleased to invite you . . . Event: Educational Opportunity Date: Thursday, March 14, 2013 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: Unblinded Monitoring Programs - Design and Education Presenter: Mary D'Rozario has a Master's Degree in Clinical Research Organization and Management from Drexel University College of Medicine, is presently an MBA student at NCSU, and holds the designations CCRP, RAC and CCRA. Ms. D'Rozario founded Clinical Research Performance, Inc. after more than 10 years of experience at Contract Research Organizations in data management, site budgets and contracts, site startup, site monitoring, and study management. Clinical Research Performance focuses on providing consulting to physician-owned sites and also provides services to companies developing products for the clinical research industry. Overview: Location: Map of Downtown Winston-Salem: Click on the following link 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 WFBMC campus may use the shuttle marked "Research Park". SoCRA CEUs: SoCRA Certified Clinical Research Professionals may claim up to one hour. SoCRA members will receive a certificate of attendance. Contact: Carrie C. Williams, CCWillia@WakeHealth.edu, 336-716-6321 We look forward to seeing you there! Upcoming Educational Event: Ohio "Northeast" SoCRA Chapter NewsDate: Thursday, May 2 Time:
Location: Come be a part of the revival of the Society of Clinical Research Associates (SoCRA) Northeast Ohio Chapter by joining us for a meet-and-greet (5:15-5:30), followed by presentations of local experts in the field (5:30-6:30). Topic: Guest Speakers:
Objectives: Objectives for Investigator-Initiated Protocols
Objectives for Investigator-initiated IND study
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. Parking: Parking is available for a fee in the E. 100th Street Garage located directly across the street from the Lerner Education Wing. RSVP: Please contact Amy Yamokoski, MA, CCRP, NE Ohio SoCRA Chapter Chairperson, at 216-445-6457 or yamokoa@ccf.org to RSVP or with any questions about this event. Oklahoma SoCRA Chapter NewsDear Colleague, You are invited to our next Oklahoma SoCRA Chapter meeting: When: Wednesday, May 8th Where: OUHSC Robert Bird Library Topic: “SOPs: Putting the Pieces together” Synopsis: How to write an SOP was the topic of most interest for the OKC SoCRA membership according to our February Survey. SOPs are required by sponsors and regulatory agencies to demonstrate sites are compliant with the ICH GCP guidelines and national regulatory regulations. SOPs are defined in the IHC GCP as "detailed, written instructions to achieve uniformity of the performance of a specific function". While they can serve as useful tools there are pitfalls in writing them. This presentation will present the rationale for having SOPs, who should be involved in writing them, how to write them, and what to include in SOPs with an emphasis that sites remember to be compliant with ICH GCP guidelines, federal and local regulations . An interactive practice writing a simple SOP to inculcate what was presented will conclude the presentation. Presented by: RSVP to : 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:
Oregon SoCRA Chapter NewsProgram to be announced. Ottawa, Ontario Canada SoCRA Chapter NewsWednesday, November 28, 2012 4:30 pm - 5:30 pm Topic: Division 5: Are you compliant? Presented by:
Objectives: At the end of the presentation:
Location: 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 Information: Co-Chairs of the SoCRA Ottawa Chapter: Brenda Bradley, RN CCRP Or Judy Cheesman, RN, C NephC, CCRP Pennsylvania / Delaware Valley SoCRA Chapter NewsThe Pennsylvania/Delaware Valley SoCRA Chapter is pleased to announce our next meeting. All are welcome to attend our education program, no membership required. DATE: Thursday January 24, 2013 (Rescheduled from October 2012) MEETING AGENDA:
LOCATION: TOPICS: "Successful Management of FDA IND Studies" FEATURE PRESENTER: Ann N. Sieber
ABOUT OUR PRESENTER: Ann N. Sieber is the Co-Manager of the Office of the Human Research and Director, Research Compliance & Quality Improvement at the Perelman School of Medicine at the University of Pennsylvania. Ms. Sieber has an exceptional record of developing and enhancing research compliance programs within large academic medical centers. Her areas of expertise include US and Global Regulatory Affairs, Federal and State Regulations, HIPAA privacy, and Conflict of Interest compliance. OBJECTIVES: This talk aims to provide an overview of the IND regulations and their practical application at the site level. Specific program objectives include
CREDIT HOURS: SoCRA members may claim up to 1.5 SoCRA CEU for SoCRA recertification. SoCRA members will receive a certificate of attendance. The Office of Human Research is an approved provider of continuing nursing education by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. This activity is designated for 1.5 Contact Hours. ATTENDANCE: Program is FREE and is open to both SoCRA & Non-SoCRA members. Registration is not required. QUESTIONS: Contact Colleen Pellegrini, BA, CCRP, Chapter Chair at colleenccrp@gmail.com. DIRECTIONS: This meeting will be held in the BRB (Biomedical Research Building 2) Auditorium, Ground Floor, 421 Curie Boulevard, Philadelphia, PA 19104 at the University of Pennsylvania. View Campus Map - type in "BRB" in search box. Public Transportation The BRB is a 10 minute walk from the University City station (SEPTA Regional Rail). To map your trip or to find out about possible delays, visit the SEPTA site. SEPTA Regional Rail: The Airport, Marcus Hook-Wilmington, Media-Elwyn and most Glenside-Jenkintown, Warminster and West Trenton trains provide direct service to the University City Station. From other Regional Rail lines, transfer free to the Airport, Marcus Hook-Wilmington, Media-Elwyn and most Glenside-Jenkintown, Warminster and West Trenton trains at 30th Street or Market East stations. Your train ticket is your transfer. SEPTA City Trains and Trolleys: The SEPTA Market/Frankford Blue Line (the elevated train/subway) stops at 34th and Market Sts. The BRB is a 10-15 minute walk from there. All SEPTA Subway/Surface Green Line trolleys except the Number 10 stop at 37th and Spruce streets; it is less than a 10 minute walk to the BRB. Loop Through University City (LUCY): The LUCY Gold Loop takes passengers from 30th Street Station and 34th and Market Streets to Curie Blvd (in front of the BRB) and then onto Penn Presbyterian Medical Center. The Gold Loop shuttle runs every 10 minutes during peak times (7 a.m. to 9 a.m. and 4 p.m. to 6 p.m.) and every 30 minutes from 9 a.m. to 4 p.m. LUCY is $2.00 or a SEPTA token for the public and is free with a SEPTA pass or ID from the University of Pennsylvania, University of Pennsylvania Health System, Drexel University, Children's Hospital of Philadelphia and the VA Medical Center. Driving Directions: Visit Google Maps for driving directions or View Penn Medicine Driving Directions. PARKING: **Charges apply** and are the responsibility of the attendee. Please note that the available parking garages are several blocks from the BRB. Self -parking is available at Lot 7, next to Penn Tower, for a flat rate of $20 per day. Lot 7 is located on Convention Avenue across from the University City train station. View Penn Parking Map. Self-park may also be available at the Penn Tower Parking Garage; valet parking is available at the Perelman Center for Advanced Medicine. Parking at both the Penn Tower and the Perelman Center are primarily reserved for patients and their families, with limited parking for campus visitors. Pennsylvania Harrisburg/Hershey SoCRA Chapter NewsThe Harrisburg/Hershey SoCRA Chapter is pleased to announce our next meeting. All are welcome to attend our education program, no membership required. Date: Wednesday, May 9th, 2012 Time: 5:00-6:30 PM Penn State Hershey Medical Center TOPICS: "Crucial Conversations to Achieve Compliance
FEATURE PRESENTER: Christina L. Gilchrist, PhD, CRA, Director of Research, WellSpan Health ABOUT OUR SPEAKER: Christy Gilchrist is the WellSpan Health Director of Research, located in York Hospital, where she oversees the operational management of administrative and fiscal functions related to the healthcare system's research program. Her areas of expertise include research design, statistical design and analysis, program evaluation, student assessment, regulatory compliance, human subjects protections, and grants and contracts research administration. CREDIT HOURS: SoCRA members may claim up to 1.0 SoCRA CEU for SoCRA recertification. SoCRA members receive Certificates of Attendance ATTENDANCE: Program is FREE and is open to both SoCRA & Non-SoCRA members. RSVP/Questions: Directions: (see 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. Pennsylvania University City SoCRA Chapter NewsThe SoCRA Pennsylvania - University City Chapter in conjunction with the Office of Human Research, Perelman School of Medicine at the University of Pennsylvania,is pleased to announce our next meeting. All are welcome to attend our education program, no membership required: "Informed Consent Forms fromthe Perspective of an IRB Community Member" Thursday November 29, 2012 Meeting Agenda: 9:00 - 10:15 Feature Presenter : Objectives: This talk aims to provide insight into the informed consent form (ICF) from the perspective of a community IRB member. Specific objectives include:
About the Speaker: Jeffrey Revello, DPM, volunteers as a Scientific Community Member for the Thomas Jefferson University IRB. He also serves as a Scientific Member on the Chesapeake Research Review IRB. In these roles, he analyzes ICFs for readability, adherence to the required elements of consent, protected populations, and legally authorized surrogates. Dr. Revello holds a Bachelor of Science from S.U.N.Y. at Stony Brook and a Doctorate of Podiatric Medicine from New York College of Podiatric Medicine. Attendance: Program is FREE and is open to both SoCRA & Non-SoCRA members. Registration: Please RSVP by Monday August 13th to Colleen Pellegrini, BA, CCRP, Chapter Chair at colleenccrp@gmail.com. Credit Hours: SoCRA members may claim up to 1.5 SoCRA CEU for SoCRA recertification. SoCRA members will receive a certificate of attendance. The Office of Human Research is an approved provider of continuing nursing education by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. This activity is designated for 1.5 Contact Hours. Questions: ContactColleen Pellegrini, BA, CCRP, Chapter Chair at colleenccrp@gmail.com Directions: This meeting will be held in the BRB (Biomedical Research Building 2), 14th floor lounge, 421 Curie Boulevard, Philadelphia, PA 19104 at the University of Pennsylvania. View Campus Map - type in "BRB" in search box. Public Transportation: The BRB is a 10 minute walk from the University City station (SEPTA Regional Rail). To map your trip or to find out about possible delays, visit the SEPTA site. SEPTA Regional Rail: The Airport, Marcus Hook-Wilmington, Media-Elwyn and most Glenside-Jenkintown, Warminster and West Trenton trains provide direct service to the University City Station. From other Regional Rail lines, transfer free to the Airport, Marcus Hook-Wilmington, Media-Elwyn and most Glenside-Jenkintown, Warminster and West Trenton trains at 30th Street or Market East stations. Your train ticket is your transfer. SEPTA City Trains and Trolleys: The SEPTA Market/Frankford Blue Line (the elevated train/subway) stops at 34th and Market Sts. The BRB is a 10-15 minute walk from there. All SEPTA Subway/Surface Green Line trolleys except the Number 10 stop at 37th and Spruce streets; it is less than a 10 minute walk to the BRB. Loop Through University City (LUCY): The LUCY Gold Loop takes passengers from 30th Street Station and 34th and Market Streets to Curie Blvd (in front of the BRB) and then onto Penn Presbyterian Medical Center. The Gold Loop shuttle runs every 10 minutes during peak times (7 a.m. to 9 a.m. and 4 p.m. to 6 p.m.) and every 30 minutes from 9 a.m. to 4 p.m. LUCY is $2.00 or a SEPTA token for the public and is free with a SEPTA pass or ID from the University of Pennsylvania, University of Pennsylvania Health System, Drexel University, Children's Hospital of Philadelphia and the VA Medical Center. PARKING: **Charges apply** and are the responsibility of the attendee. Please note that the available parking garages are several blocks from the BRB. Self -parking is available at Lot 7, next to Penn Tower, for a flat rate of $20 per day. Lot 7 is located on Convention Avenue across from the University City train station. View Penn Parking Map Self-park may also be available at the Penn Tower Parking Garage; valet parking is available at the Perelman Center for Advanced Medicine. Parking at both the Penn Tower and the Perelman Center are primarily reserved for patients and their families, with limited parking for campus visitors. Please share this announcement with your colleagues. South Carolina Upstate Hub City SoCRA Chapter NewsDate: Monday, April 29, 2013 Time: 6:00 PM - 8:00PM Topic: Informed Consent for Adults and Children under South Carolina Law Objectives of the presentation are: To understand the law of consent for medical procedures in South Carolina Speaker: Steve Williams, JD One of lead attorneys for South Carolina's largest acute care hospital system. Specializing in clinical research compliance, physician acquisitions and transactions, physician employment issues, patient care issues, bioethics issues, integration of service lines and delivery of care, healthcare policy issues for the hospital system, and counsel regarding system communications and publications. CEU: One hour CEU credit is offered for this session for SoCRA members Location: Marsha and Jimmy Gibbs Cancer Center Auditorium Parking: Cancer Center Parking Area Cost: Free Admission. All members and non-members welcome. Please RSVP for refreshment-planning reasons only. A light supper is planned. RSVP: Morgan Gable, RN, CCRP, OCN at mgable@gibbscc.org or 864-560-7579 Please share this announcement with your colleagues. We are anticipating an enthusiastic turnout to discuss the future of our chapter. Tennessee, Greater Nashville Regional SoCRA Chapter NewsThe Greater Nashville Regional SoCRA Chapter will offer the following Program: "Investigational Device Exemptions: What Level of Oversight is Required for Your Human Subjects Device Research?" Speaker: Date/Time: Place: Overview: After this session participants should be able to:
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 in accordance with the Essentials Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Vanderbilt School of Medicine and the Society of Clinical Research Associates. Vanderbilt School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. Vanderbilt School of Medicine designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the 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. Please bring your lunch. For directions, please contact wendy.lloyd@vanderbilt.edu. SoCRA has approved this program for 1.0 continuing education contact hour for members. Tennessee, Greater Smoky Mountain Regional SoCRA Chapter NewsThe Greater Smoky Mountain Regional SoCra Chapter Is proud to Present: April 25, 2013 Speaker: Place: Time: Program Objectives will be: After this session participants should be able to:
Members and non-members welcome. For Directions and RSVP, please contact Brenda Wear at wear_brenda@yahoo.com or at 865-924-2891. SoCRA has approved this program for 1.0 continuing education contact hours for SoCRA members. Please share this announcement with your colleagues. Food and Beverages will be available for purchase. Please share this announcement with your colleagues. Tennessee, Mid-South SoCRA Chapter NewsTransitioning to an Electronic Data/Document Management System in the Clinical Trials Process: Benefits and Challenges Location: Date: Wednesday, May 1, 2013 Time: Panelists:
Moderator: Janie Gardner, MS, CCRP, CIM Objectives: At the end of this session, attendees will be able to:
Contact /RSVP: Continuing Education: SoCRA has designated this educational activity for a maximum of 1.0 CE credit. Certificates are awarded to SoCRA members. Please share this announcement with your colleagues. Texas, Central SoCRA Chapter NewsWe are pleased to announce an educational opportunity hosted by the Central Texas SoCRA chapter. Date: Monday, December 10, 2012 from 12:00 noon until 1:00 pm Location: Topic: Objectives: Describe the Care Transitions Intervention project at Scott & White Memorial Hospital
Presenter: CE: 1.00 SoCRA CEUs will be awarded for SoCRA Members Only SoCRA members will receive Certificates of Attendance Texas, Dallas-Fort Worth SoCRA Chapter News16 MAY 2013 @ 6:00 PM Texas Health Fort Worth Presentation Title: Legal Implications of Research Presenter: Cathy Dykes MS RN CCRC CCRP By the end of the lecture, the attendee will be able to:
Credit Available:
RSVP: Cathy Dykes 817-250-7860 Texas, Greater Houston/Galveston SoCRA Chapter NewsThe Greater Houston/Galveston SoCRA Chapter will be hosting an educational conference on April 20, 2013 at Hermann Conference Center, Memorial Hermann - Texas Medical Center, 6411 Fannin, Houston TX 77030. Program Schedule: 9:00 - 10:00" 10:00 - 11:00: 11:00 - 11:15 Break 11:15 - 12:15 "Clinical Research Risks from an Institutional Site Perspective" by Cheryl Chanaud, PhD, CCRP 12:15 - 1:15 Lunch 1:15 - 2:15 "HIPAA in Research" by Christina Solis, J.D. 2:15 - 3:15 "DSMBs" by Martha Mims, MD, PhD 3:15 - 3:30 Break 3:30 - 4:30 "Site Study Budget Preparation and Negotiation" by Linda C. Higgins, CCRP 4:30 - 5:00 Q&A regarding SoCRA Chapter SoCRA Members will have the opportunity to earn 6 CEUs. REGISTRATION IS REQUIRED DUE TO SPACE LIMITATIONS! Please provide your name and e-mail address to Aryn Knight at apolk@bcm.edu or Linda C. Higgins at lhiggins@bcm.edu by APRIL 1st. Free parking will be provided at MH Medical Plaza, 6400 Fannin St, Houston, TX. A sign, "Event", will direct everyone to park in the basement. Please pull a ticket when you arrive and upon leaving the parking garage the arm will automatically go up. Please see http://mhmp.com/directions-parking for directions to the building. Directions to Hermann Conference Center from MH Medical Plaza parking garage: Take elevator to the 2nd level. Turn right pass "Zen & Now Boutique", keep walking, turn left to cross the sky bridge. Go all the way down, turn left and then a quick right, keep going to the escalators. Go down escalators, turn left pass Hermann Children's elevators, go down escalators to the bottom floor. Hermann Conference Center is right there. Lunch will not be provided. You may bring your lunch or there are restaurants and cafeterias available. Please share this announcement with your colleagues. Texas, Greater San Antonio SoCRA Chapter NewsDate: Tuesday, April 30, 2013 Time: 12:30-1:30 pm
Title of the program: "Preparing Research and Medical Staff for an FDA Inspection" Speakers: Objectives of the presentation:
Location of Meeting: Directions: 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 August 23, 2012 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 Texas, West SoCRA Chapter NewsDate/Time: Thursday, March 7, 2013, 12:00 CST* Topic: Lies, More Lies, and Statistics Speakers: Phillip Watkins Objectives: Upon completion of this presentation, the participants will be able to:
Locations:
For further information: Terry Fountain, CCRP, 806-775-8590 Please RSVP: 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. Tokyo, Japan SoCRA Chapter NewsDate: October 13, 2012 Time: 13:00 - 17:30 (12:30 - Registration) Location: Pharmaceutical Sciences Research Bldg 2F, University of Tokyo, Tokyo, JAPAN Address: 7-3-1, Hongo Bunkyo-ku, Tokyo Japan Directions / Map: www.u-tokyo.ac.jp/en/about/documents/accessmap_E.pdf www.u-tokyo.ac.jp/en/about/documents/Hongo_CampusMap_E.pdf Program: 13:00 - 13:05 Opening 13:05 - 14:25 Session 1: ICH-GCP 14:25 - 15:25 Session 2: Ethical Guidelines for Clinical Research 15:25 - 15:40 Break 15:40 - 17:10 Session 3: Code of Federal Regulations (CFR) 17:10-17:30 Announce of examination for CCRP 17:30 Closing Language: Japanese only CCRP credit: 4.0 CE Participation fee: - for SoCRA member : FREE - for NON SoCRA member: 3000JPY for JSCTR member / 4000JPY for NON JSCTR member Japanese information: www.j-sctr.org/seminar/index.html Advanced registration (by October 5, 2012 ) - for SoCRA member : Please email SoCRAJapan_Committee@umin.ac.jp including your name, affiliation - for NON SoCRA member: go online at www.j-sctr.org/seminar/index.html (JSCTR web page) SoCRA Toronto, Canada SoCRA Chapter News (Greater Toronto)SOCIETY OF CLINICAL RESEARCH ASSOCIATES Greater Toronto Area Chapter presents: Clinical Research guided by GCP: comparing good clinical practices between Canada and a Cancer Research Institute in Northern India Speaker: Learning objectives:
1 hr CE for SoCRA members Date: Thursday, May 16th, 2013 Time: 5:30pm-7:00 pm Location: RSVP: Robert.Halford@uhn.ca Videoconferencing is available via the Ontario TeleHealth Network If you plan to attend videoconference at CREDIT VALLEY HOSPITAL RSVP: Anne Abraham: Anne.Abraham@trilliumhealthpartners.ca If you plan to attend via videoconference at Hotel Dieu Hospital, Kingston RSVP: Jenna Ekborn: ekbornj@queensu.ca New videoconference sites welcome. Utah SoCRA Chapter NewsDate: Friday, September 9, 2011 Time: 9:00 a.m. to 11:00 a.m Location: Room: HSEB 2600 Title: Clean Data and Complex Trials: Can this Marriage be Saved? Speakers:
Brief Program Description: Interactive discussion on clinical trials data in multicenter research. 9:00-10:45 Presentation, 10:45-11:00 Discussion. Program Objectives:
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. Vancouver, Canada SoCRA Chapter NewsDate: Friday, June 15, 2012 Time: 8:30am-11:30am Topic: Clinical Trials in BC Presentations & Speakers:
Objectives of the presentations are:
3.0 CEUs: Three hours of CEU credits are offered for this session for SoCRA members Location: Royal Columbian Hospital Directions & Parking/Skytrain Information Please visit the following website for further details: www.fraserhealth.ca/find_us/locations/our_locations?site_id=1790 Cost: Free admission. All members and non-members welcome RSVP:To register, email camille.viray@fraserhealth.ca with your name, title, department and place of work. Use subject line: RSVP - Day 5 More Information: Erin Cherban, Vancouver Chapter Chairperson Please share this announcement with your colleagues. Vancouver Island, Canada SoCRA Chapter NewsWe 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: Date: December 3, 2010 Time: 0815-1300 Location: Royal Jubilee Hospital Meeting Room: Woodward Room, 124l Contact person: SoCRA Chapter Chair, Anika Patel To Register: 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:
The learning objectives will be to:
8:15 - 8:45 Registration and Coffee 8:45 - 9:15 Welcome & Introductions 9:15 - 10:00 Derogate Data or Data Devine 10:00 - 10:45 What We Do and Why We Do it: A Behind the Scenes Look at Clinical Data Management 10:45 - 11:00 Health Break 11:00 - 11:45 Data Collection and Queries: the Good, the Bad and How to Avoid the Ugly 11:45-12:00 Questions and Discussion 12:00-13:00 Networking Lunch Virginia, Roanoke SoCRA Chapter NewsThe Roanoke Valley SoCRA Chapter is pleased to announce the next scheduled meeting: Date: Wednesday March 13, 2013 Time: 1:00-2:30 PM Location: Guest Speaker: Topic: "The Symbiotic Relationship between Clinical and Basic Research: The Value of Collaboration among Clinicians and Basic Scientists in the Advancement of the Biomedical Sciences." 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:
Virginia (Southeastern) SoCRA Chapter NewsThe Southeastern Virginia Chapter will present the following educational program on Friday, May 17, 2013 from 12:00PM - 1:30PM in the Brickhouse Auditorium of Sentara Norfolk General Hospital. CE: SoCRA members will recieve 1.5 CEUs. Certificate of Attendance will be given to SoCRA members. Speaker: Title of talk: Bias in Clinical Trials (with Emphasis on Site-Level) Learning Objectives:
Contact person for questions/ RSVP: Autumn Scibelli, CCRP, Chapter Chair Directions to Brickhouse Auditorium, Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, VA 23507 (www.sentara.com): From North Suffolk / Smithfield
From Hampton / Newport News / Williamsburg (via Monitor-Merrimac Bridge Tunnel)
From Hampton / Newport News / Williamsburg (via Hampton Roads Bridge Tunnel)
Vermont SoCRA Chapter NewsDate: Wednesday, March 31, 2010 Time: 12:00-1:00 EST Title of Program: Speaker Name: Ellen Travis, FNP, MSN Location: 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
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:
For more information contact the Vermont Chapter Chair: Washington SoCRA Chapter NewsDate: Thursday, March 7, 2013 Time: 5:00 PM - 6:00 PM Speaker: Lead Auditor and Assistant Project Manager for the Coalition of Cancer Cooperative Groups Topic: "Introduction to Medidata Rave® as a model for Electronic Data Capture (EDC) " SWOG, a national multi-site cancer clinical trials cooperative group, has implemented Medidata Rave® as their primary electronic data capture (EDC) solution for trials beginning in 2012. Using their experience as an example, attendees will learn about the different features that Rave® offers, how studies built in Rave® are presented to site personnel, and how understanding these EDC processes may benefit your practice whether or not you are affiliated with SWOG. Using Rave® for EDC
Building studies in Rave®
CEU: SoCRA members may claim up to 1.0 SoCRA CEU for Location: RSVP: Merle Witter, CCRP mtwitter@comcast.net Parking: Metered parking is available on the street and there Driving Directions: From Interstate 5 southbound
From Interstate 5 northbound
Washington D.C. "National Capital Area" SoCRA Chapter News
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