Jamie:

The FDA issued a draft guidance document on 1572's in 2008... reference for detailed information http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf

Specifically, the guidance provides clarification, by stating it should include in the 1572 any individual who is directly involved in the treatment or evaluation or research subjects or who make a direct and significant contribution to the data.  Furthermore, a specific pharmacist that is compounding the drug or monitoring compliance probably SHOULD be listed. Likewise, a coordinator that is only transcribing data and maintaining regulatory files does not need to be listed, BUT a coordinator that is obtaining consent, collecting and evaluating study data SHOULD be listed.

-Dusty

Dusty Layton, BS, CIP
Director, Research Compliance and Assurance
University of South Alabama
CSAB 128
Mobile, AL 36688
251-460-6625

>>> Jamie Kauwell <xxxxxx@GEISINGER.EDU> 6/9/2009 1:28 PM >>>
Hi All,
Can you tell me who you include on your 1572? We were not including coordinators on our 1572 and lately our sponsors are telling us we must include coordinators.

Thank you,
Jamie

Jamie Kauwell MHA CCRC
Administrative Research Coordinator
Geisinger Center for Clinical Studies
Henry Hood Center for Health Research
100 N. Academy Ave
Danville, PA  17822-4400
Phone# 570-214-9405
Fax# 570-271-6944
xxxxxx@geisinger.edu

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