Fda 1572”:

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The following content appears as a section within the FDA document called, “INSTRUCTIONS FOR FILLING OUT FORM
FDA 1572”:
FIELD 6: NAMES OF SUBINVESTIGATORS
21 CFR 312.3(b) states: “In the event an investigation is conducted by a team of individuals, the investigator is the
responsible leader of the team. ‘Subinvestigator` includes any other individual member of that team.” 21 CFR
312.53(c)(1)(viii) requires the investigator to provide “a list of the names of the subinvestigators (e.g., research fellows,
residents) who will be assisting the investigator in the conduct of the investigation(s).”
The purpose of Field 6 is to capture information about individuals who, as part of an investigative team, will assist the
investigator and make a direct and significant contribution to the data. The decision to list an individual in Field 6 depends
on his/her level of responsibility (i.e., whether he/she is performing significant clinical investigation-related duties). In
general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of
data, that person should be listed on the Form FDA 1572. For example, if the protocol notes that each subject needs to
visit a specified internist who will perform a full physical to qualify subjects for the clinical investigation, that internist
should be listed in Field 6.
Hospital staff, including nurses, residents, or fellows and office staff who provide ancillary or intermittent care but
who do not make a direct and significant contribution to the clinical data, do not need to be listed individually.
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Question: Using the above information from the FDA, along with the information covered during Unit 2 about the
detailed content covered within the ACRP CCRC Examination, in general, should a Clinical Research Coordinator (Study
Coordinator) be required to be listed in Field 6 of the Form FDA 1572? You will need to provide detailed support for your
response.

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