FDA has made some big changes in the final version of their Frequently Asked Questions (FAQ), Statement of the Investigator (Form FDA 1572) Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (May 2010). The FAQ states that research coordinators (study coordinators) should “usually be listed in Section #6 of the 1572.” This is a significant change from the draft FAQ Information Sheet Guidance that came out in July 2008. Many clinical sites do not list study coordinators on the FDA 1572. It means that most study coordinators will need to file financial disclosure information. It will be a significant change in the way FDA inspects clinical sites. Specifically the FAQ document states:
“Generally, a research coordinator has a greater role in performing critical study functions and making direct and significant contributions to the study data. For example, a research coordinator often recruits subjects, collects and evaluates study data, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572.”
You can review this in Section 33, page 14 of the Final FAQ on FDA 1572s. This is a big change from the July 2008 draft FAQ:
“If a research coordinator is performing critical study functions and collecting and evaluating study data, the coordinator should be listed on Block #6.”
This is a very significant difference and not just because they changed “Block #6” to “Section #6.” FDA is saying that a study coordinator “generally” performs critical study functions. And FDA says that recruiting subjects is one of those functions. Obtaining informed consent, although not stated in the FAQ, is also regarding as a critical function. FDA made that clear in a Warning Letter issued October 1, 2008. The Warning Letter states:“Study coordinators who administered the informed consent, determined subject eligibility and dispensed study drug were not listed on the Form FDA 1572, Statement of Investigator, for protocols (b)(4) and (b)(4). By performing these significant study activities, the study coordinators should have been listed on the Form FDA 1572s as subinvestigators.”
Although the 1572 FAQ, like all FDA Guidance Documents, states that it “Contains Nonbinding Recommendations,” the Warning Letter makes it crystal clear that “nonbinding” only goes so far. My advice?
Put your study coordinators on the 1572 pronto.
UPDATE: Remember that the FAQ does not need a CV for subinvestigators, just financial disclosure. It’s in the FAQ
UPDATE 6 January 2011: Two Important New GCP Documents:
There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)
There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:
“Sec. 50.25 Elements of informed consent.
* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”
Another update: Read an updated version of this article in
Applied Clinical Trials
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For some reason WordPress isn’t showing comments for this post:
Just discovered your blog and find it rather helpful. Our site is looking at the new 1572 guidance and will be implementing changes soon. I am not happy with the guidance for Sub-Investigators (VII, Section #6, #31) because it still leaves the interpretation wide open as to who provides “direct and significant contribution to the data.” We do oncology research and the nature of the care and treatment of these patients means that dozens of staff are involved. An auditor could intrepret that each of those staff members has a significant contribution to the “data.” I am not comfortable that Section #6, #32 protects us.
I know the Delegation of Authority log was never an official FDA document but it seemed a much more efficient means of informing Sponsors of who was conducting procedures for their studies. For me the 1572 should be reserved for those who make the decisions that a clinical trial is appropriate for given research subjects and for whom financial (or other) incentive could bias the enrollment and outcome of a trial . In our situation, that would be the physians who order the treatment for their patients. Staff assist in that process, but a study coordinator is never the one who decides that a treatment is appropriate. What brought about the need to expand the definition of who is a “sub-investigator?”
Thanks for your comment:
I basically agree with you about the study delegation log. It was in the guidance “Investigator Responsibilities” (October 2009) and I thought that it was a good vehicle for this type of situation. I do not have a clue why this has been emphasized at this time. Please make sure you look at section 32 of the FAQ where it addresses residents:
“Concerning staff residents on rotation, it may be difficult to prospectively identify those individuals who might perform specified protocol procedures or collect clinical data. Specific names of the rotational staff do not have to be listed in Section #6. Instead, to successfully address this scenario, the names of rotational individuals and the procedures they are expected to perform should be included in the clinical study records.”
This paragraph is at the top of page 14 in the FAQ.