The Society of Clinical Research Associates, Inc. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.

10,500 Members; 5,629 Certified Clinical Research Professionals "CCRP"; 28+ educational programs in 2008; 72 examination sites; and the 17th Annual Conference will be held in Vancouver, British Columbia - September 26-28, 2008.

The express aim of SoCRA is to provide training and continuing education for clinical research professionals and to establish and maintain an international certification program for clinical research professionals.

New FDA Guidance for Industry Computerized Systems Used in Clinical Investigations

The FDA published the new guidance document for electronic records, "Guidance for Industry Computerized Systems Used in Clinical Investigations." Click Here (PDF).

New Canada Travel Passport Requirement

USA Today News (PDF)

Pending Passport Applications:

If you have applied and have not yet received your passport because of delays:

1. Visit the website www.travel.state.gov.
2. Follow the directions and print out the confirmation form that states that you have applied.

Taking this form along with your picture ID (driver’s license) will meet the passport requirements for Canada, Mexico, Bermuda or countries in the Caribbean region.

Member Benefit - BioResearch Compliance Alert

SOCRA members get 50% off a new subscription to BioResearch Compliance Alert through the end of this year - just $295 per year (plus $40 if outside of U.S.). This publication focuses on GCP and GLP compliance, covering both OHRP and FDA issues. You also will receive FREE our weekly news update, listing new clinical trials and trial new updates, plus OHRP, FDA and other human subject protection and patient monitoring news.
Here's a link to the weekly news update: www.fdainfo.com/bimoonline/bico012506.htm.
Just call FDAInfo at (800) 776-5105 to subscribe, or email FDAInfo at Service@FDAINFO.com

Member Benefit - Drexel eLearning Tuition Discount

As a member of SoCRA, you are eligible to receive a 10-25% reduction off the regular on-campus tuition rate at Drexel University when you take courses online. As an added benefit, spouses of SoCRA members are also eligible to receive the same tuition reduction for Drexel's online programs through this educational collaboration. Pursuing a degree has never been easier, or more affordable!

Delivered fully online, Drexel's programs are highly interactive and are designed for working professionals seeking to earn a degree or additional certification. The online programs follow the same high academic standards and lead to the same quality degrees as on-campus, with no commuting or career interruption.

To learn more about this collaboration and Drexel’s online programs, please call the program Director, William L. Hirschhorn, at (610) 292-9525 or e-mail WHL23@drexel.edu.

To qualify for these reduced tuition rates, members and their spouses should use "SOCRA" as your affiliation code when you complete an application.

Topics in Focus:

Device Clinical Trials - Regulatory Considerations by Michael E. Marcarelli, Pharm.D. (412 KB PDF)

Past Topics in Focus Articles

SoCRA Education Calendar Highlights

The Society of Clinical Research Associates is pleased to highlight our SoCRA Education Calendar with you.

The SoCRA Certification Prep Course (CPC) is being offered in:
Vancouver, BC, Canada in September 2008.

The Prep Course is a one-day preparation and review course for the CCRP (Certified Clinical Research Professional) designation.

The SoCRA Clinical Site Management Workshop - designed for the site coordinator, research associate, study nurse, and site manager - will be held in:
Albuquerque, NM in October 2008.

This program addresses all of the functions of the research site related to CFR and ICH Good Clinical Practices.

The SoCRA Monitoring Workshop will be held in:
Philadelphia, PA in October 2008.

This two-day program truly helps both coordinators and monitors to understand the responsibilities and activities required of the research monitor.

The SoCRA Clinical Science Course (CSC) is being offered in:
Scottsdale, AZ in November 2008.

The Clinical Science Course is a five-day program (two modules for your choice), presenting a clinical research orientation and stressing; in module 1: CFR and ICH GCP, Planning and Budgeting, AE reporting, IRB operations, Source Document Management and Research Ethics; and in module 2: Anatomy and Physiology, Cell Biology, Genetics, Lab Science, and Statistics and Epidemiology.

The SoCRA FDA Clinical Trial Requirements Conference will be held in:
Kansas City, MO in November 2008.

This conference on the FDA's clinical trial requirements is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities, and authority of the FDA, and to facilitate interaction with FDA representatives.

The SoCRA Clinical Investigator Workshop will be held in:
Clearwater Beach, FL in December 2008.

This program addresses all of the functions of the clinical investigator and the HIPAA requirements.

The SoCRA Standard Operating Procedures (SOPs) Development and Implementation Workshop will be held in: Ft. Lauderdale, FL in February 2009.

This program for Senior Clinical Research Professionals will introduce, explain, and discuss concepts and current issues in the development and implementation of SOPs for the investigational site.

The SoCRA Legal, Ethical and Practical Considerations in Protecting Human Research Participants will be held in: Denver, CO in April 2009.

This program is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities and authority of the FDA and OHRP Department of Health and Human Services.

The SoCRA Device Research Workshop will be held in:
Chicago, IL in May 2009.

This 2-day Device Research program for Clinical Research Professionals will introduce, explain, and discuss fundamental concepts and current issues relating to research subject protection and development and marketing of MEDICAL DEVICES in the current regulatory environment.

The SoCRA Advanced Site Management: Finance Workshop will be held in:
Philadelphia in October 2009.

This program is designed to assist Site Managers, Site Coordinators and Research Associates in improving their skills and their understanding of the practical financial and business tasks related to clinical research.

The SoCRA Certification Program

The SoCRA Certification program offers the designation "Certified Clinical Research Professional" to eligible researchers. Click the calendar for the examination schedule!

The SoCRA Classifieds

The SoCRA Classifieds offer listings of organizations seeking clinical researchers.

SoCRA's 17th Annual Conference in September, 2008