Sites Comment on FDA Draft Guidance Documents through SCRS

FOR IMMEDIATE RELEASE
January 24, 2013
Rockville, MD

Sites Comment on FDA Draft Guidance Documents through SCRS

Rockville, MD – January 24, 2013 –The Society for Clinical Research Sites (SCRS) is committed to its first pledge that through SCRS sites will have and share their voice for the benefit of the entire clinical research enterprise.  SCRS responded on behalf of its almost 300 site members from over 12 countries with the site’s perspective on the two recently issued FDA Draft Guidance Documents:

Guidance for IRBs, Clinical Investigators and Sponsors IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed &; Guidance for Industry: Electronic Source Data in Clinical Investigations.

Christine Pierre, President of SCRS, says, “SCRS was founded to represent the global site community and to be actively involved in the dialogue surrounding the clinical research enterprise.  This is a monumental first step for the site community to have collectively contributed to the important discussion surrounding both of these documents.  We are excited that SCRS could facilitate process and look forward to being available to other industry stake holders looking to strengthen their position by ensuring the site’s view point is considered.”

Mark Lacy of Benchmark Research and Chair of the Public Policy Committee of SCRS says “through SCRS sites now have a community and leadership to help ensure the sites are contributing to the dialogue that usually impacts the sites operations.”

About SCRS

SCRS is the trade association representing the global clinical research sites.  Through the society, sites will become active partners in industry-wide dialogues focused on improving the clinical research enterprise.  SCRS has a mission of advocating on behalf of its members, connecting sites and other stakeholders to build a purposeful community, educating sites and the industry to create a foundation for informed action, and mentoring sites to help sustain and build a strong site foundation.  Membership in SCRS is open to clinical research sites and companies that sponsor or support the work conducted at sites.  Visit www.myscrs.org.

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Contact
Denise Davis, Event and Communication Coordinator
Society for Clinical Research Sites
410.696.5080
denise.davis@myscrs.org