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New: Chapter Development Highlights (PDF)

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

Chapters are listed alphabetically, by state/country.

Arizona (Phoenix) Valley of the Sun SoCRA Chapter News

MEETING ANNOUNCEMENT

Tuesday, March, 30, 2010

6:00– 8:30 PM

Location:
Medicis Pharmaceutical Corporation
Tonopah Conference Room
7720 North Dobson Road
Scottsdale, AZ 85256

Speaker:
Jessica Myers, CCRP, is a Regulatory Compliance Associate for Clinical Research Advantage. Prior to her current position, Ms. Myers worked for Hill Top Research in the positions of Study Coordinator and Quality Assurance Auditor. She specializes in the creation, execution, and maintenance of regulatory documentation required in clinical trials. She has a B.S. in Molecular Biosciences/Biotechnology and has been a member of SoCRA since 2007.

Topics and Objectives: The topics presented will review 21 CFR information as well as the practical application of the regulations within a clinical trial.

Informed Consent – From Discussion to Documentation

  • Understand and apply FDA regulations in the Informed Consent discussion
  • Meeting FDA requirements when documenting Informed Consent

Adverse Events – The In’s and Out’s of Reporting

  • Understand reporting requirements from the regulations, the IRB, and the protocol
  • Learn some tips on the collection and documentation of information

Pizza will be provided during the meeting for an optional $5 per person.

CEC Available: 2 Hours

RSVP:
Please RSVP to: Shaun O’Conor oconors@msn.com or 480-600-6816.

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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 March meeting of the Northern California Chapter of SoCRA, the Society of Clinical Research Associates.

Topic: Nuremberg: Tyranny on Trial (History Channel Documentary)

Speaker:
Rayanne Hildreth, CCRP Sr. Clinical Research Coordinator, UC Davis Clinical and Translational Science Center

Date and Time: Tuesday, April 20, 2010 , 12:00-1:00PM

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

Cost: FREE admission (All members and nonmembers welcome)

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

For more Information: Please contact the following individuals:

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

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

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: Friday, July 23, 2010

Time: 5:45-6:45 PM

Topic: Patient Recruitment Strategies for Industry

"This presentation will include the generation and implementation of the recruitment plan, study center, and research community involvement. The applicable regulatory guidelines will be discussed. How a sponsor/CRO can plan for recruitment success and support site recruitment will also be addressed."

Speaker:
Janice Sidorick, MPH
President & CEO of Janix, LLC
Contract Research Organization

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

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

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

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

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

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California (San Diego) SoCRA Chapter News

Meeting Announcement

Date: June 23, 2010 Wednesday

Time: 6:00 - 7:00 PM

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

Speaker: Jonathan Mack, PhD, RN, NP, West Wireless Health Institute

Topic: Wireless Health Technology and Emerging Trends: What is Coming and How CRC/CRA Can Prepare

Jonathan Mack is a Post Doctoral Fellow at the West Wireless Health Institute whose research focus is Healthcare informatics and Clinical application of wireless technology. Dr Mack will be sharing the interests and developments at the West Wireless Institute and discuss the potential impact on the future clinical trials.

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: June 22, 2010

Time: 12:00-1:00 PM. Please bring your own lunch.

Agenda: Regulations and IRB Review

Alison and Ita will present a brief overview of the Federal Regulations and how they pertain to the operations of COMIRB.

CE: (1 SoCRA CEU) will be offered.

Speakers:
Alison Lakin, COMIRB Director and Ita Leitner, COMIRB Exempt/ Expedited Coordinator

Location: University of Colorado Denver, Anschutz Campus, building- Education 2 North - P28-1102

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

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

Area map and Fitzsimons campus map

Area Map

Fitzsimons Campus Map

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Connecticut SoCRA Chapter News 

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

Date:
Wednesday, August 4, 2010
5:30pm Registration and Dinner provided
6:00pm Presentation and Discussion

Location:
Flemings Steakhouse
44 South Main Street
West Hartford, CT 06107

Seminar Theme: Stroke Disease Awareness and Secondary Risk Reduction

Presented by:
Cindy Meng, PharmD
Cardiovascular Medical Liaison
Medical Affairs, Sanofi-Aventis

Objectives:

  • Review the epidemiology, classification, and clinical presentation of ischemic stroke.
  • Identify patients at risk for ischemic stroke.
  • Explain atherothrombosis and the cross-risk associated with stroke.
  • Review the 2008 AHA/ASA guidelines for secondary stroke reduction and clinical treatment guidelines for hypertension, hypercholesterolemia and diabetes.
  • Identify The Joint commission stroke center quality measures.
  • Discuss stroke center quality improvement initiatives.

CE: *Qualifies for 1 Continuing Education Credit hour for SoCRA CCRP Renewal.

Please Pre-Register by e-mailing Cherie Bilbie, CCRP at cbilbie@harthosp.org or Bertha Robbins, CCRP at brobbin@ccmckids.org by July 29th For more information contact Cherie at (860) 545-0088 or Bertha at (860) 545-9523.

Parking options include:

  • Garage parking in the Memorial or Isham Garage
  • Street parking is available around the restaurant that is both free and metered
    depending on where it is located

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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/Suncoast SoCRA Chapter News 

Date: Thursday, June 24, 2010

Time: 5-7 PM

Location:
All Children’s Hospital
Outpatient Care Center (Conference Room A, 1st Floor)
601 5th Street South, St.
Petersburg, FL, 33701

Speakers:
Frances Hamblin, RN, BSN, CCRP Clinical Research Manager -
Pediatric Oncology at All Children’s Hospital
& Jennifer Flanary, RN, BSN, Hematology/Oncology Research Coordinator- All
Children’s Hospital

Title of Program:
One Size Does Not Fit All: Special Considerations in Coordinating Pediatric Clinical Research

Goals of Educational Offering:

  • Review regulatory requirements for conducting pediatric clinical research
  • Discuss ethics of including children in research
  • Learn who can provide consent for the child and when assent is required
  • Present case studies

All individuals interested in this educational offering are welcome.
There will be 1 (one) CEU provided for this Program for SoCRA members.

Questions about the meeting? Contact Debra Mimo, RN at dmimo@tampabay.rr.com with any questions.

Questions about the location? Contact Frances Hamblin, RN at 727-767-2423

Please RSVP to Debra Mimo at 813-317-0788 or dmimo@tampabay.rr.com.

We look forward to seeing you there!

DIRECTIONS

From St. Petersburg/Tampa:

  1. Take I-275 south. Exit at I-175.
  2. Exit at 6th Street South and make a right.
  3. Make your first left at 6th Avenue South.
  4. Make the first right at 5th Street South.
  5. The parking garage is located just behind the Outpatient Care Center. Parking is free.
  6. Conference Room A is located on the first floor of the Outpatient Care Center. It is the last conference room on the left.

From Sarasota/Bradenton:

  1. Take I-275 north. Exit at I-175.
  2. Exit at 6th Street South and make a right.
  3. Make your first left at 6th Avenue South.
  4. Make the first right at 5th Street South.
  5. The parking garage is located just behind the Outpatient Care Center. Parking is free.
  6. Conference Room A is located on the first floor of the Outpatient Care Center. It is the last conference room on the left.

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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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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: July 26, 2010

No Cost Please RSVP to get a printed certificate for your CE.

Doors open: 6:00 p.m. for Networking

Presentation: 6:30 p.m. - 7:30 p.m. (one hour of CE)

Speaker:
Anne N. Martien, MBA, CCRP, CRCP
Regulatory Specialist, Center for Cardiac and Vascular Research

Topic:
Protocol Design for Clinical Trials
The content and design of a protocol will be evaluated. Steps in the process will be defined. Errors to avoid will be discussed. Then we will learn from each other through a group discussion on protocol writing and lessons learned.

Location:
Enoch Pratt 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: 1.0 hour of CE is available for SoCRA members.
Certificates of attendance will be provided.

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

Seating: 80 participant room capacity

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 way, please call or e-mail Anne Martien.

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Massachusetts SoCRA Chapter News

Date: Wednesday, July 14, 2010 Cancelled

Time: 5:00pm- 6:00pm

Location:
Dana-Farber Cancer Institute
20 Overland Street, 3rd Floor
Red Sox A & B Conference Room

Topic: Human Subject Protections

Speaker: Michele Russell-Einhorn, JD, Senior Director Office for Human Research
Studies

Speaker Affiliation: Dana-Farber Cancer Institute

Overview: Discuss the protection of human subjects which are in place for clinical research trials thru the review of history, current regulations and examples of non-compliance. Specifically, the roles and responsibilities of IRB's, the elements of consent and pertinent FDA regulations will be reviewed.

Objectives:

  • Briefly review scientific review process
  • Review regulatory issues involved in the protection of human subjects in research to ensure adequate substantive review, consistency and thoroughness of IRB review and approval and continuing oversight of research involving human subjects.

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

Please share this announcement with your colleagues.

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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)

The SEMN SoCRA Chapter Meeting on Tuesday, July 27, 2010

  • 5:00 - 5:30 PM Gathering/Networking
  • 5:30 - 7:00 PM
    Mark Wentworth, CCRP
    Senior Regulatory Specialist
    Mayo Clinic Office of Research Regulatory Support
    Rochester, MN

Title: “Overview of Good Clinical Practice Guidelines for Research”

Objectives:

  • State the origin of the ICH guidelines for Good Clinical Practice
  • List the Federal Regulations related to clinical research
  • Define the purpose of the ICH guidelines for GCP in clinical research
  • Recognize the responsibilities of clinical researchers

1.5 CEUs offered

Location:
Geffen Auditorium, Subway level of the Gonda Building, Mayo Clinic Rochester Campus.
Parking is available at City and Mayo ramps
No RSVP required

Inquiries can be directed to:

Lori Bratvold at bratvold.lori@mayo.edu

Linda Knowlton at lindalung2000@yahoo.com

Tammy Neseth at neseth.tammy@mayo.edu

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 a SoCRA Educational Opportunity.

Title: Criteria for IRB Approval

Guest Speaker:
Bruce Gordon, MD, FAAP
Chairman, UNMC Institutional Review Board
Chairman, Joint Pediatric Institutional Review Board
Professor
Pediatric Hematology/Oncology & Stem Cell Transplantation
University of Nebraska Medical Center

Objectives:

  • Understand the ethical requirements for research involving human subjects
  • Understand the characteristics of research harms and benefits
  • Understand the Regulatory criteria for approval by an IRB

When:
Wednesday, July 21, 2010
12:00 - 1:00 p.m.

Where:

Host site: University of Nebraska Medical Center, Omaha, NE

Location: MSC 1005

Videoconference site:
Sanford Medical Center, Sioux Falls, SD

Location:
Carlson Conference Room
And
University of Nebraska Medical Center, Omaha, NE
Location: MSC 2018

See directions below for both facilities.

Teleconferencing may be available upon request. RSVP – 4 days in advance.

Please contact Mary Morris to reserve your video or telephone connection
memorris@unmc.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 Creighton University, Criss Building, Room 252

Located on the SE corner of Burt St. and Wareham Pkwy (approx. 28th and Burt).
Please use link for campus map and more specific directions:
www.creighton.edu/maps/

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: Wed., July 14, 2010

Time: 6-7:00pm

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

Guest Lecturer:
Rebecca Wahler, MS, Privacy Officer
LCF Research
Albuquerque, NM

Topic: HIPAA: What has changed, a brief review of the changes between HIPAA and the ARRA updates

Content: The presentation will address the specific changes to HIPAA in regards to Breach Notification requirements, fines for Breaches, and impact on Business Associates.

Objectives:
1. Basic understanding of what is a Breach under the HITECH Act
2. Basic understanding of tiered penalty system for Breaches
3. Basic awareness of how to evaluate own risk in regards to unintended Breaches

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

One hour of SoCRA Continuing Education Credit is available.

Mark your calendars for the remaining 2010 Chapter Meetings
October 13, 2010

Directions:

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

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

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

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New York Hudson Valley SoCRA Chapter News

New York Hudson Valley SOCRA Chapter - Southern 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

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

Thursday, June 17, 2010

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

RSVP: Kathi Durdon (durdonk@welchallyn.com, FAX 315-217-0408)

Agenda:

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

9:15 - 10:15 a.m. "Infection Prevention and Control - My Experience in Haiti"
Susan (Sue) Dubay, MPA, BSN, RN, Senior Manager, CM&S, Welch Allyn
On January 12, 2010, a 7.0 magnitude earthquake hit just 10 miles west of Port-au-Prince Haiti a city with 2 million inhabitants with 80% living under the poverty line. This major disaster was viewed by many over the airways and internet. While many saw the devastation through the media, some had the privilege of traveling to the area to assist with medical relief. The discussion will take you through personal experience in Haiti sharing the clinical challenges that were faced with infection prevention and control in a area that was challenged with having the most basic of needs.

10:15 - 11:15 a.m. Evidence-based practice: Theory and application
Dr. Lynda J. Dimitroff, PhD, BSN, RN, CHES and Dr. Lynn W. Nichols, PhD, RN
Department of Nursing Research & Evidence-Based Practice Rochester General Hospital
Evidence-based practice (EBP) is the integration of high quality and relevant research, clinical expertise, and patient values. EBP creates an opportunity for healthcare providers to stop and assess what they are doing, why they are doing it, and to decide if there is a better way to complete the process. The goal of EBP is to improve quality of patient care, ensure better patient outcomes, and improve both patient and staff satisfaction.

EBP may be applied to clinical settings in a variety of ways including pathways, protocols, policies, procedures, and practice changes. EBP is a way to evaluate our practice and to make sure that it is research-based, clinically up-to-date, and best practice for our patients. In an effort to successfully implement EBP, healthcare providers must be able to identify the clinical problem, search for the best evidence, critically appraise the evidence, synthesize and apply the evidence, and evaluate the outcomes.
This session will provide an opportunity to understand the importance and benefits of EBP and explore the barriers to implementing EBP. In addition, we will look the steps involved in the EBP process as well as applying EBP to a clinical setting.

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

11:30 - 12:00 p.m. "Proper Technique for BP Management"
Donna Williams, RN, CCRP, Clinical Research Associate, Welch Allyn
Blood pressure measurements are often taken inaccurately. This session will review the necessary steps to assure blood pressure is taken appropriately, whether in patient care or in the conduct of research.

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

1:00 - 2:00 p.m. "Conflicts of Interest in Physician-Industry Relations: Has the Pendulum Swung Too Far?"
Nancy Nussmeier, MD, Professor and Chair, Department of Anesthesiology, SUNY Upstate Medical University
A recent NEJM article discussed the congressional mandates to reformphysician-industry relations with key changes beingmade to policies at various academic medical centers, professionalsocieties, and companies. The Institute of Medicine defined a conflict of interest as "a set of circumstancesthat creates a risk that professional judgment or actions regardinga primary interest will be unduly influenced by a secondaryinterest." The primary interests of concern include "promotingand protecting the integrity of research, the welfare of patients,and the quality of medical education." Secondary interests "mayinclude not only financial gain but also the desire for professionaladvancement, recognition for personal achievement, and favorsto friends and family or to students and colleagues." But has reform come at a price? This presentation will discuss how Conflicts of Interest have or may have lasting effects on the conduct of research between academia and industry.

2:00 - 3:00 p.m. "Towards Ethical Conduct of Research: Focus on Publishing"
Martha F. Nelson, RN MS MPA, Program Manager, United Health Services Hospitals, Inc., Office of Clinical Trials
This presentation will offer considerations on ethical authorship practices, provide tips on the publication submission process. Dr. David Resnick at NIH describes the following ethical considerations, "First, norms promote the aims of research, such as knowledge, truth, and avoidance of error. Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work, such as trust, accountability, mutual respect, and fairness. This and additional considerations will be discussed.

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

3:15 - 4:15 p.m. "To Be A Study Site or Not To Be, These Are The Questions!"
Robert A. Dracker, MD, MHA, MBA, CPI, Owner and Medical Director at Summerwood Pediatrics, Liverpool, NY; Medical Director, SyraMed Sciences
This presentation will review the pertinent issues which should be considered by the Prinicipal Investigator and the clinical research staff with regards to the relative value of the study under consideration, the right site "fit" relative to the study site facilities and resources and what final value there is in participating with any particular study. Understanding the dynamics of the sudy sponsor, the research administrator and the research site assets, both with regards to personnel and facilities is significant for any clinical researcher, regardless of their level of experience.

4:15 - 4:30 p.m. Program Discussion

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

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

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North Carolina (East) SoCRA Chapter News

This month's chapter meeting will feature Dr. Amber Barnes, Regulatory Scientist, Cato Research. Dr. Barnes will be speaking on "Informed Consent Content & Process Requirements"

DATE: August 2, 2010

OUR TOPIC: Informed Consent Content & Process Requirements

SPEAKER: Amber Barnes, PhD, RAC, Regulatory Scientist, Cato Research

SUMMARY:

Dr. Barnes' presentation will focus on the elements of the informed consent document, and the components of the process. Industry specific scenarios will be presented to reinforce important concepts, for example: evaluating and documenting capacity to consent, voluntariness, HIPAA authorization, withdrawal of consent, and more. Discussions will also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.

Upon completion of this presentation, the participants will:

  • Examine required content of the ICF
  • Define the informed consent process per regulations and best practices
  • Clearly define who and what determines if consent has been adequately executed
  • Review elements that must be included in an authorization for use and disclosure of protected health information

ABOUT OUR SPEAKER:

Dr. Amber Barnes is a RAC-certified regulatory scientist with over 6 years of research experience and over 3 years of industry experience. As a former graduate of Meredith College (B.S., Molecular Biology and Chemistry) and Wake Forest University School of Medicine (Ph.D., Molecular Medicine) she performed pharmaceutical research in the field of gynecologic oncology. Currently, Dr. Barnes serves as a regulatory scientist on clinical trials, safety monitor in adverse event reporting, and a project manager at Cato Research, a full-service CRO.

CREDIT HOURS: This program offers 1.0 SoCRA CEUs

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 Cato Research

CATO is located at 4364 S. Alston Ave. (Westpark Corporate Center) All attendees should park and enter through the back of the building. The meeting will be held in the 3rd floor Auditorium, from 6:00-7:00 PM . Please sign in at the reception desk and take the elevator to the 3rd floor. Exit the elevator to your left and follow the arrows to the Auditorium. Upon entering the Auditorium, please sign the SoCRA attendance sheet.

Directions to Cato Research From Raleigh/RDU Airport to Cato Research:

  1. Take Interstate 40 WEST (toward Chapel Hill) to Exit 278 (Apex 55/54)
  2. Drive straight through the traffic light, over the railroad tracks, into WESTPARK CORPORATE CENTER
  3. (The Waffle House will be on the left and the Comfort Inn will be on the right)
  4. Drive around to the back of the office building to locate parking

Directions from Greensboro/Chapel Hill to Cato Research:

  1. Take Interstate 40 EAST toward Durham/Raleigh to EXIT 278 (Apex 55/54)
  2. Drive under the bridge to your left and turn RIGHT at the next traffic light
  3. Drive over the railroad tracks, into WESTPARK CORPORATE CENTER
  4. (The Waffle House will be on the left and the Comfort Inn will be on the right)
  5. Drive around to the back of the office building to locate parking

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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: Tuesday May 25, 2010

Time:

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

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

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

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

Guest Speakers:

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

Objectives:

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

SoCRA CEUs: 1.0

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

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

DRIVING DIRECTIONS:

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

From North

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

From South

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

From West

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

From East

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

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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, April 28, 2010

5:00 PM – 6:00 PM

Location: The Children’s Hospital of Eastern Ontario. Research Institute 1 Room R154

Topic: “Jeopardy – Research Documentation”

Test your GCP knowledge on source documentation in an interactive setting. Group participation in a Jeopardy game with Hostess Sheila Ledoux!!

Presneted by:
Sheila Ledoux RN CCRC
Research Education & Documentation Coordinator
CHEO Clinical Research Unit

Room directions: Follow signs to the Foundation Office then down the hall.

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

DATE: Wednesday, May 12th, 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: “Strategies in Processing, Negotiating, and Executing the Clinical Trial Agreement”

FEATURE PRESENTER:

  • Ronald Polizzi
    Associate Director, Contracts in the Office of Research Administration:
    Thomas Jefferson University

    Ronald Polizzi is the Associate Director, Contracts in the Office of Research Administration at Thomas Jefferson University. His current responsibilities are to predominantly negotiate and process research contracts, clinical trial agreements, and confidentiality agreements for the university’s research function. Mr. Polizzi has been in Research Administration for over 16 years and held many positions at varying universities. He received his MBA from Monmouth College and is a Certified Research Administrator. He is well versed in research administration, contract negotiation, scientific integrity and the responsible conduct of research.
  • Brian Kuhlmann
    Clinical Trials Budget Specialist in the Office of Research Administration:
    Thomas Jefferson University

    Brian Kuhlmann is a Clinical Trials Budget Specialist in the Office of Research Administration at Thomas Jefferson University. His current responsibilities include Medicare coverage analyses for qualified clinical trials and review and negotiation of clinical trials budgets. Mr. Kuhlmann has been in clinical research administration for the past three years, after several years in the consulting industry. He received his MBA from the University of Iowa, Tippie School of Management.

OBJECTIVES:

  • Discuss what are some of the difficult terms and why does the negotiation just seem to drag out
  • Discuss what indemnification and subject injury language should be included to adequately protect the institution and enrolled subjects
  • Review how to budget based on sound accounting principles, billing compliance, and an accurate analysis of the protocol
  • Provide tips on negotiating and establishing payment schedules

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 Drexel University Online for their support of this program, including light refreshments during the meeting.

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

DIRECTIONS:

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

Driving Directions:

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

Public Transportation

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

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

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

PARKING: 2 Options:

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

Wednesday, July 28, 2010

Room 898B Preston Research Building
Vanderbilt University Medical Center

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

12-1 PM

Featured Topic:
Recruit, Retain, Record: Keeping Tract of Participants, Data and Samples in Large-Scale Research Studies

Some research questions can only be answered using large scale, population-based research studies. However, keeping track of participants, their data and samples can be daunting. After this presentation, participants should be able to:

  • Describe multiple recruitment and retention techniques for research studies and understand the related personnel, time and financial costs.
  • Understand and incorporate methods for collecting, tracking and storing various types of biological samples.
  • Understand issues of consent, privacy and researcher responsibility related to collection, storage and analysis of biological samples.

Speaker:
Sandra Deming, PhD MPH

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

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

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

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

Members and non-members welcome.

Please bring your lunch.

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

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

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Tennessee, Mid-South SoCRA Chapter News

"Conference on Clinical Research"

Thursday, June 17, 2010

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

Agenda:

7:30 a.m. Registration

8:00 a.m. Welcome

8:15 a.m. FDA Regulations in Clinical Trials
K. Gary Barnette, Ph.D.
Vice-President, Clinical R&D Strategy, GTX

  • Describe what the FDA expects in a pharmaceutical clinical trial
  • Describe how pre-IND meetings and the FDA meeting process assist the research goal
  • Discuss how the IRB regulations and FDA's mechanisms assure compliance
  • Give some examples on the FDA actions taken when clinical research study fails to meet federal regulations

9:15 a.m. Ethics in Clinical Research
Javier Kane, M.D.
Chair, St. Jude Ethics Committee and Director, Division of Palliative and End-of- Life Care, St. Jude Children's Research Hospital

  • Learn about the concept of personhood and the rights of human research subjects.
  • Learn to identify ethical dilemmas and the foundational principles to guide decision making.
  • Review important case examples and a method for ethical deliberation in difficult situations.

10:15 a.m. Networking Break

10:45 a.m. Differences between Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs): A Practical Review
Sandra Williamson
Director, Regulatory Affairs, Medtronic Spinal and Biologics
To compare and contrast IND and IDE submissions:

  • Investigator Brochure in an IND v. Report of Prior Investigations in an IDE.
  • Form 1572 is required for IND but not for IDE.
  • Investigator Site Agreements are required for IDE but not IND.

11:45 a.m. Closing Remarks

Registration Deadline: The deadline to register is Thursday, June 10, 2010.

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

Target Audience: The Conference is designed for principal investigators, clinical research coordinators, clinical research associates, site monitors, and other professionals working in the field of clinical research.

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

For more information, please contact Hani Rashed, M.D. at 901-595-5782 or hani.rashed@stjude.org or Alisa M. Firehock at 901-448-6977 or alisa.firehock@tctn.org.

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Texas, Greater Houston/Galveston SoCRA Chapter News

Thursday, April 15, 2010, 12-1 pm

The Greater Houston Chapter in conjunction with BCM Research Compliance Services would like to invite you to the
Clinical Research Educational Session (CReEd):

“Genomic Data Repositories and Informed Consent”

Thursday, April 15, 2010, 12-1 pm
Room 301A in the Cullen Building (Bertner Street entrance) of the main Baylor campus

Presenter:

Amy L. McGuire, JD, PhD
Associate Professor of Medicine & Medical Ethics
Associate Director of Research
Center for Medical Ethics & Health Policy

Brown Bag Lunch

If you have any questions, please contact researchcomplianceservices@bcm.edu.

No reservations are necessary. We look forward to seeing you on Thursday.

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.

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

Please share this announcement with your colleagues.

Sponsorship: Jointly sponsored by the Society of Clinical Research Associates and The Methodist Hospital Research Institute.

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.

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

June 3, 2010, 12:00 CST*

Topic: “The Consent Process in Research”
Part 2: Common Informed Consent Mistakes

Speaker:
Chad Copeland, M.Ed., M.P.A.
Research Compliance Officer
Texas Tech Health Sciences Center. Lubbock, Texas

Objectives:

Upon completion of this presentation the participants will:

  • Be familiar with specific mistakes often found in regulatory audits.
  • Be familiar with common informed consent errors that could stop or discard research.
  • Be able to be prepared for an IRB, Sponsor, or Federal research audit.

Locations:

  • Lubbock – ACB 220 (Academic Classroom Building – located at front of HSC on 4th and Indiana)
  • El Paso – 235 (*11:00 AM)
  • Amarillo – 4720
  • Odessa – 2C91

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

Please RSVP by May 14, 2010:terry.fountain@umchealthsystem.com

Feel free to bring 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

June

July

The June Japan SoCRA Chapter Meeting

Title 1: Changed points of RECIST ver.1.1 from ver.1.0 and CTCAE ver.4.0 from ver.3.0

Title 2: Design of cancer clinical trials and recent topics of treatment in lung, gastro-intestinal and breast cancers

Date: June 20, 2010

Time: 13:00 - 16:10

Location:
Institute of Biomedical Research and Innovation, 4th Floor Training Room
2-2,Minatojima-Minamimachi Chuo-ku、Kobe Japan

Directions / map: www.ibri-kobe.org/english/foundation.html#3

Program:

12:30 - 13:00
Registration

13:00 - 14:30
Title 1: Changed points of RECIST ver.1.1 from ver.1.0 and CTCAE ver.4.0 from ver.3.0

Speaker: Takashi Nishimura, MD

Speaker affiliation: Kyoto - Katsura Hospital, Department of Respiratory Medicine

Dr. Nishimura will explain new version of the Response Evaluation Criteria in Solid Tumors (RECIST) and the Common Terminology Criteria for Adverse Events (CTCAE), especially the different points between the new versions and the old. The latest RECIST in Japanese is going to be released soon and a booklet about the latest CTCAE in Japanese was released a few months ago. So it is time for CRPs in oncology to understand them in detail and how they will make our daily practices different.

14:30-14:40
Break

14:40-16:10
Title 2: Design of cancer clinical trials and recent topics of treatment in lung, gastro-intestinal and breast cancers

Speaker: Nobuyuki Katakami, MD & PhD

Speaker affiliation:

  • Director Department of Clinical Trial, Institute of Biomedical Research & Innovation
  • Oncology Chief．Division of Pulmonary Medicine, Kobe City Medical Center General Hospital

Dr. Katakami will give a lecture on the design of clinical trials in oncology. In addition, he will introduce the latest therapy of lung, gastro-intestinal and breast cancers. It is very important to study recent trends of therapies and research in these fields.

Language: Japanese only

CCRP credit: 3.0 CE

Participation fee: free (SoCRA member and candidate for membership)

Japanese information: www.crsu.org/SoCRA_Japan/

Advanced registration: Please email SoCRAJapan_Committee@umin.ac.jp including your name, affiliation, by June 11, 2010

Please see the announcement in Japanese.

The July Japan SoCRA Chapter Meeting

Title1: Design of oncology clinical trials

Title2: RECIST ver. 1.1 differences from ver. 1.0

Title3: CTCAE v4.0 differences from v3.0

Date: July 31, 2010

Time: 13:00 - 16:40

Location: meeting place: National Cancer Center Tokyo, JAPAN

Address: 5-1-1, Tsukiji Chuo-ku, Tokyo Japan

Directions / map: www.ncc.go.jp/en/about/access.html#ncc

Program:

12:30 -13:00 Registration

13:00 - 14:30 Title1: Design of oncology clinical trials

Speaker: Haruhiko Fukuda
Speaker affiliation: Center for Cancer Control and Information
Services, National Cancer Center
Dr. Fukuda will give us lecture about the design of oncology clinical trials. He is going to cover basic topics, which are easy to understand for CRPs. It must be beneficial to understand protocol more.

14:30-14:40 Break

14:40-15:40 Title2: RECIST ver. 1.1 differences from ver. 1.0

Speaker: Hirokazu Watanabe
Speaker affiliation: National Cancer Center Hospital
Dr. Watanabe will introduce the new version of Response Evaluation Criteria in Solid Tumors. Its Japanese version is going to release soon, so it's time to get familiar with it. He will stress on changed points from previous version.

15:40-16:40 Title3: CTCAE v4.0 differences from v3.0

Speaker: Masashi Ando
Speaker affiliation: National Cancer Center Hospital
Dr. Ando will explain about the new version of Common Terminology Criteria for Adverse Events, especially revised points. If there are questions through experiences in use, please feel free to ask him.

Language: Japanese only

CCRP credit: 3.5CE

Participation fee: free - SoCRA member and candidate for membership

Japanese information: www.crsu.org/SoCRA_Japan/

Advanced registration: Please email SoCRAJapan_Committee@umin.ac.jp including your name, affiliation, by July 21, 2010.

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Toronto, Canada SoCRA Chapter News (Greater Toronto)

"Biospecimen Management"

Speaker:
Anne Eisenhauer, BSc., MSc.
Princess Margaret Hospital Correlative Studies Program

Date: Thursday, Jun 17 2010

Time: 6:00pm-7:30pm

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

Objectives:

  • Understanding why biospecimens are collected in clinical trials
  • Understanding the importance of biospecimen management
  • Best practices from biopspecimen collection to disposal

RSVP:
susanna.sellmann@uhnresearch.on.ca
If you plan to attend videoconference at CREDIT VALLEY HOSPITAL
Contact: Tabassum Tahir: TZahir@cvh.on.ca

SoCRA CE credit: 1 hour

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, June 18, 8:00 am to 1:15 pm

Location: Royal Columbian Hospital, Sherbrooke Centre, Lounge, 260 Sherbrooke Street, New Westminster, BC

Directions & Parking Information:
www.med.ubc.ca/faculty_staff/faculty_development/program/workshop_venues/rch_sherbrooke_hospital.htm

Agenda and Speakers:

8:00-8:30 Sign-in & Breakfast

8:35-9:05 Building Clinical Research Infrastructure and Harmonizing Practices in B.C, Heather Harris-Harper, British Columbia Clinical Research Infrastructure Network Coordinator, Genome BC

  • Structural changes taking place within the BC Health Authorities coupled with sustained research funding at federal and provincial levels are providing an ideal opportunity to integrate the outcomes of biomedical research at the heart of the healthcare delivery system in B.C. The main research-intensive health centres, the health authorities and UBC medical school have created the BC Clinical Research Infrastructure Network (BCCRIN), an umbrella organization with a vision to integrate clinical research capabilities throughout B.C.
  • The BCCRIN will drive the development of a harmonized and coordinated network promoting clinical research and clinical trial activity that will transform the B.C. landscape in this regard. It is well established that patients treated in environments strong in clinical research have improved clinical outcomes and B.C. is poised to position itself as a vibrant centre for these activities over the next decade.

9:05-9:50 What the Canadian Medical Protective Association (CMPA) Wants Clinical Investigators to Know, Dr. Robert Rivington, Senior Medical Officer, Physician Consulting Services

  • An explanation of how the CMPA is allowed to assist physicians who engage in clinical research.
  • CMPA’s general information on clinical research contracts.

10:05-10:50 Global Competitiveness, Darren Cowan-Bittner, Regional Team Leader-Western Canada, Clinical Research, Pfizer Canada Inc.

  • This presentation will explain how competitive Canada is on the global market and will provide insight into the current state of pharmaceutical company studies in general.

10:50-11:20 The Role of the Data Safety Monitoring Boards, Ruth Milner, Ph.D, Senior Consultant, Clinical Research Support Unit, Child and Family Research Institute, Children’s and Women’s Hospital

  • Learn more about the role of the Data Safety Monitoring Board and how they influence the clinical studies that you participate in.

11:20-12:05 Recruitment and Office for Human Research Protections (OHRP) Update, Jeffrey Toward, PhD, Continuing Review Manager, Office of Research Ethics, University of British Columbia

  • Recruitment within the local institutions will be discussed and questions will be answered.
  • An update about the OHRP review will be provided.

Lunch will be provided.

Questions: Email Erin Cherban, Vancouver SoCRA Chapter chairperson at gcpconsultants@shaw.ca

To register: Email camille.viray@fraserhealth.ca and specify DERS-061810 in the subject line

SoCRA CEU’s: This program offers 3.25 hours of Society of Clinical Research Associates (SoCRA - www.SoCRA.org) CEU credit

Please share this announcement with your colleagues.

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Vancouver Island, Canada SoCRA Chapter News

We are pleased to announce the first meeting of the SoCRA Vancouver Island Chapter, May 28, 2010, at the Royal Jubilee Hospital, Begbie Hall, 2192 Richmond Road, Victoria, BC V8R 1J8.

Topic: 5th Vancouver Island Clinical Research Educational Symposium

Date: May 28, 2010

Time: 0815-1500

Location: Royal Jubilee Hospital

Meeting Room: Woodward Room, Begbie Hall

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

To Register:
Email to: Anika.Patel@viha.ca
Register by May 19, 2010 ** Seating limited and fills up quickly!

Up to 4.5 SoCRA CEUs will be awarded

Topics to be discussed include:

  • 0845-0915 Welcoming Comments and Continuing Education
  • 0915-1000 From Protocol to Site Selection: The Role of Feasibility Assessments in Clinical Trial Planning
    Jacqui Whiteway, PhD, Senior Clinical Research Scientist, PRA International
    What factors are involved in the decision to proceed with a clinical trial and how does site selection fit in? Hear directly from a Feasibility Specialist about the many important decisions that are made behind the scenes before a clinical trial is implemented.
  • 1015-1100 Do Trial Sites Need Standard Operating Procedures?
    Rosalie Chartrand-Rodrigue, Head, Clinical Quality & Compliance, Vifor Pharma
  • SOPs are an important part of ensuring the quality, efficiency and consistency of clinical trial conduct at a site. Learn from a Regulatory Specialist about which SOPs are essential, what has to be in them and if there are regional differences in these requirements.
  • 1100-1145 A Day in the Lifecycle of a Safety Report
    Gillian Winstanley, MSc, Senior Mgr, Clinical Trial Safety Operations, Amgen Canada
  • Sites, CRAs and REBs are directly involved in the review and processing of individual safety reports. Sponsors have different ways of managing the Process but all have the same goal of ensuring effective and timely communication of safety information. Learn from an industry Safety Specialist about what actually happens to an individual SAE report once it leaves a site and why.
  • 1145-1200 Open Panel Discussion
  • 1300-1500 GCP Update: Advanced Refresher, Workshop and Q&A
    Rosalie Chartrand-Rodrigue, Head, Clinical Quality & Compliance, Vifor Pharma

We are pleased to offer an intermediate to advanced level GCP upgrade training session and workshop conducted by a Regulatory Specialist! The session will close with a Q & A session for attendees to raise actual GCP compliance questions based on their own experience, so come prepared with your questions!

Please share this announcement with your colleagues.

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Virginia (Southeastern) SoCRA Chapter News

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

Date: June 22, 2010

Time: 10:00 - ll:30 AM

Place: The Roper Auditorium located in Lewis Hall Campus of Eastern VA Medical School in Norfolk, VA.

Speaker: Commander Sherry Secrist , FDA, Baltimore District

Topic: "FDA Conduct of Clinical Investigator Inspections"

Objectives: Commander Secrist's will discuss:

  • Clinical Investigators' Responsibilities
  • What to expect during an FDA inspection
  • Common deficiencies (observations)
  • Possible outcomes of FDA inspections
  • Tips for a successful study
  • Preparing for site visit

CEUs: This presentation will provide 1.5 CEUs


RSVP: Please email requests for additional information and/or your RSVP to Susan Perkins at PerkinSR@evms.edu. You may also call 757-668-6416.

Parking is available in the Medical Center's Main Visitor's Parking lot. Campus visitors must take a ticket on entry that must be presented on exit to calculate payment based on $1 per hour charge (to a maximum of $8).

Link to: Campus Map

Driving directions to campus.

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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, July 14, 2010

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

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

Room: Desert Center Floor 3E

Presentation: Implications of Genetics and Genomics on Research and Practice

Presenter: Kathleen Calzone, MSN, RN, APNG, FAAN

Objectives:

  • Describe the basic genetic and genomic underpinnings of health and illness
  • List three developments in genetics and genomics that influence therapeutic interventions and research
  • Identify four implications of genetic and genomic information for research and practice

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."

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

  • 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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SOCRA.  The Society of Clinical Research Associates  •  530 West Butler Avenue, Suite 109, Chalfont, PA 18914 USA  •  (800) SoCRA92 or 215-822-8644