Clinicaltrials.gov was created by FDAMA in 1997 and went live in 2000. From the Act (my emphasis): "A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life threatening diseases and conditions under regulations promulgated pursuant to section 505(i) of the Federal Food, Drug, and Cosmetic Act, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials,
a description of the location of trial sites, and
a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public."
For me, this has always been interpreted to mean that a general location of the site (city, state) was all that was needed if there was a point of contact, which often is the Sponsor or CRO. The reference to individual site status is in the context of recruitment status. The practice you describe is perfectly acceptable.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 25-Feb-2022 17:37
From: Anonymous Member
Subject: ClinicalTrials.gov Study Record: Clinical Site Information
This message was posted by a user wishing to remain anonymous
Do the applicable regulation(s) specify what participating site information must be included in a ClinicalTrials.gov study record? I noted that 42 CFR 11.28(a)(2) makes reference to "individual site status", but I can't find the specified site details (required by the Protocol Registration and Results System [PRS]) in the regulations. These site details include facility name, city, and country in addition to site contact name, phone number, and e-mail address.
It seems to me that these details fulfill the spirit of the law (FDAAA 801) and regulations...to inform the public.
Some sponsors/responsible parties do not include site details in a study record for various reasons. Others include generic site numbers (e.g., "Site Number 101") with city/state/country and provide for all sites only a central contact number and e-mail address of a sponsor representative (not individual site contact details). Is this acceptable? It does not appear to be fully compliant with PRS information.
Thank you in advance for your input.