14,558 + Members; 9,627 + Certified Clinical Research Professionals "CCRP"; 40 + educational programs in 2013; 93 examination sites, in 2012. The 22nd Annual Conference will be held in New Orleans, LA – September 27-29, 2013 - at the Sheraton New Orleans Hotel.

Our mission is to provide training, continuing education, and an internationally recognized certification program that promote quality clinical research to protect the welfare of research participants and improve global health.

SoCRA 2013 Election Results

Click here to view the SoCRA 2013 Election Results.

AAHRPP’s Standard I.7.A.

Click Here for AAHRPP’s clarification of their Standard I.7.A. pertaining to IRB approval of protocols for Phase 1 trials, specifically the issue of whether an IRB can approve advertising, recruiting, and screening procedures to begin prior to the end of the 30-day FDA review period or prior notification from FDA.

Revised FDA Compliance Program Guidance Manual

We feel that you should be advised that FDA has issued (March 11, 2011) a revised Compliance Program Guidance Manual (CPGM) for FDA Staff, for inspections of Sponsors, Contract Research Organizations and Monitors (CP 7348.810). By reading this guidance, you will understand exactly what the FDA investigator will be seeking to verify. The guidance will help you to assure that your own practices, policies and procedures address all of the areas noted in Part 3 – Inspectional. Part 3 involves evaluation of the sponsor’s/CRO’s/monitor’s practices and procedures in order for FDA Investigators to determine compliance with applicable regulations.

SoCRA’s Clinical Research conferences and workshops all address the regulations, guidance and practices involved in clinical trials through lecture, case studies, and discussion.

SoCRA Annual Conference
FDA Clinical Trial Requirements
Site Management Workshops
Clinical Research Monitoring Workshops
Clinical Investigator Conference

FDA Requires New Informed Consent Elements

The Food and Drug Administration (FDA) is amending the current informed consent regulations (21 CFR Part 50) to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

This rule is effective March 7, 2011. The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date. See section III of the document for an additional explanation of the compliance date and required implementation of this final rule. See Federal Register: Informed Consent Elements for all details relating to this final rule.

SoCRA 2010 Salary Survey

Click Here for the 2010 Survey Results!

Click Here for the 2004/5 Survey Results.

SoCRA Chapter Links for Non-English Speaking Members

Updated 2011 Edition of the “International Compilation of Human Research Protections”

Click Here

In addition to numerous additions and updates to the 2010 Edition provided by in-country contact persons, the 2011 Edition features a new sub-section on the laws, regulations, and guidelines on medical device research, which is found in the “Drugs and Devices” section, and the laws, regulations, and/or guidelines for five new countries: Belarus, Grenada, Pakistan, Rwanda, and Tunisia.

Form FDA 1572 May 2010 Guidance

Click Here

New FDA Guidance on Investigator Responsibilities

FDA has issued final guidance on "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects." Click Here

New FDA Guidance on Regulations for Registration of IRBs

This guidance is intended to assist institutional review boards (IRBs) in complying with the new requirement for IRB registration. (See 74 FR 2358 (Jan. 15, 2009)). This requirement is an amendment to Part 56, Institutional Review Boards, (21 CFR 56.106), that requires each IRB in the United States (U.S.) that reviews FDA-regulated studies to register. IRB registration information is entered into an Internet-based registration system maintained by the Department of Health and Human Services (HHS).
Click Here (PDF).

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).

SoCRA Offers CNE and CME for Conferences, Seminars, and Workshops; CPE

Some boards of pharmacy accept CME to satisfy CPE; pharmacists should check with their local board of pharmacy regarding policy.

SoCRA offers CNE (Continuing Nurse Education) and CME (Continuing Medical Education) for all conferences, seminars and workshops.

• CNE for Nurses: SoCRA is approved as a provider of Continuing Nurse Education by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.
• CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Online Courses - Please Click Here.

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

	FDA Clinical Trial Requirements Seattle, WA May, 2013 Atlanta, GA November, 2013
	Conducting Clinical Trials in Canada Toronto, ON, Canada May, 2013
	Certification Prep Course Toronto, ON Canada June, 2013 Baltimore, MD August, 2013
	Advanced Site Mgt: Finance Vancouver, BC, Canada June, 2013 San Diego, CA December, 2013
	SOP Workshop Toronto, ON CANADA June, 2013
	Monitoring Workshop Vancouver BC June, 2013
	Clinical Site Management Philadelphia, PA July, 2013 Orlando, FL November, 2013
	Clinical Science Course Denver, CO July, 2013 Las Vegas, NV October, 2013
	Harnessing Social Media to Advance Clinical Research Philadelphia, PA August, 2013
	Project Management Las Vegas, NV October, 2013
	Clinical Investigator Workshop Tampa, FL December, 2013
	Clinical Trial Management Systems (CTMS) Conference for Clinical Research Programs TBD
	Legal, Ethical and Practical Considerations in Protecting Human Research Participants TBD
	Device Research Conference TBD

The SoCRA Classifieds

The SoCRA Classifieds offer listings of organizations seeking clinical researchers.

Topics in Focus:

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

Past Topics in Focus Articles

The SoCRA Certification Program

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

New! NCI Promotional Tools Increase Awareness of Clinical Trials

The National Cancer Institute (NCI) announces the availability of two new patient education posters and a pin to increase awareness about clinical trials. Their purpose is to begin the discussion with cancer patients that a trial may be a reasonable option in the continuum of their cancer care. To get more information about the NCI posters and pins, call the National Cancer Institute’s Cancer Information Service toll-free at 1-800-4-CANCER or visit www.cancer.gov. To order posters directly, please click: POSTERS and for pins, please click: PINS.

Member Benefit: No-cost Basic GCP and Research Protections On-line Education

SoCRA offers no-cost basic GCP and Research Protections on-line education.

SoCRA has joined The Collaborative Institutional Training Program (CITI) to offer SoCRA members free entry-level Basic Courses in the Protection of Human Research Subjects including Biomedical Focus, Social and Behavioral Focus, and Refresher Courses, as well as the basic course on GCP (Good Clinical Practice course).

Click Here for information about CITI.

Click Here to register for courses. Under “Participating Institutions” - click on “Society of Clinical Research Associates (SoCRA)”

Those wishing to accrue CME by taking these programs should read on. Click Here to find out more! 

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 and immediate family members 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! SoCRA-related online programs include MS in Clinical Research Organization and Management, MSN in Clinical Trials Research and well as shorter certificate programs. Additional discounted programs include undergraduate and graduate programs in business, human resources, nursing, engineering, information systems, education and health sciences.

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 visit the SoCRA partner page at www.drexel.com/socra or contact the SoCRA partnership liaison, Jolynn Howell, at 215-571-4190, Jolynn.Howell@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.