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FDA is saying that a study coordinator "generally" performs critical functions, such as subject recruitment.
The Form FDA 1572, Statement of the Investigator, is a basic contract between a clinical investigator and the FDA. It is required in allclinical trials conducted under an Investigational New Drug application. It has also been the source of numerous discussions about exactly who belongs inSection 6 as a subinvestigator. Now, FDA is making it clear.
FDA has made some big changes in the final version of the Information Sheet Guidance for Sponsors, Clinical Investigators, andIRBs—Frequently Asked Questions—Statement of the Investigator (Form FDA 1572), released in May. The FAQ states that study coordinators should"usually be listed in Section #6 of the 1572." This is a significant change from the July 2008 draft FAQ. Many sites do not list studycoordinators on the FDA 1572, which means that most coordinators will need to file financial disclosure information. It will be a significant change inthe way FDA inspects sites.
Specifically, the FAQ document states: "Generally, a research coordinator has a greater role in performing critical study functions andmaking direct and significant contributions to the study data. For example, a research coordinator often recruits subjects, collects and evaluates studydata, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572."
This is a big change from the draft FAQ that says: "If a research coordinator is performing critical study functions and collecting andevaluating study data, the coordinator should be listed on Block #6." This is also a very significant difference, and not just because they changedBlock #6 to Section #6.
FDA is saying that a study coordinator "generally" performs critical functions, and that recruiting subjects is one of them.Obtaining informed consent, although not stated in the FAQ, is also regarded as a critical function. FDA made that clear in a Warning Letter issued byCDER to an investigator in October 2008: "Study coordinators who administered the informed consent, determined subject eligibility, and dispensedstudy drugs were not listed on the Form FDA 1572, Statement of Investigator, for protocols (b)(4) and (b)(4). By performing these significant studyactivities, the study coordinators should have been listed on the Form FDA 1572s as subinvestigators."
There are other helpful pieces of information in the FAQ. For example, it asks in Section 24: "Are CVs required to be signed anddated?" The answer: "No...The investigator's dated signature on the 1572 is sufficient to attest to the accuracy of the CV or otherstatement of qualifications submitted with the 1572." This should reduce tensions between sites and CRAs who sometimes think that a signed CV isnecessary every year.
In Section 34 it asks: "Is a statement of qualifications (CV) required for subinvestigators?" The answer? "No. The regulationsat 21 CFR 312.53(c)(1)(viii) require only that subinvestigators' names be listed in Section #6 of the 1572." This lessens the burden ofcollecting additional CVs from subinvestigators that you may be adding to the FDA 1572. However, you will still want to document their qualifications.And FDA states in Section 35 that they want financial disclosure from subinvestigators listed in Section #6 of the 1572.
A final important note: If a study coordinator is performing critical study functions and is listed on the 1572, they need to understand theregulatory responsibilities listed on the 1572 that they are now assuming.
Carl Anderson Regulatory Compliance Consultant Carl A. Anderson, LLC