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The Form FDA 1572, Statement of the Investigator, is a basic contract between a clinical investigator and the FDA. It is required in all clinical trials conducted under an Investigational New Drug application. It has also been the source of numerous discussions about exactly who belongs in Section 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, and IRBs—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 study coordinators on the FDA 1572, which means that most coordinators will need to file financial disclosure information. It will be a significant change in the way FDA inspects 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."
This is a big change from the draft FAQ that says: "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 also a very significant difference, and not just because they changed Block #6 to Section #6.
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