Instructions For Filling Out Form Fda 1572 - Statement Of Investigator (Page 2 of 3) in pdf

If a laboratory is sending samples to satellite or other contract labs for additional testing, it is only necessary

to list the primary laboratory, provided that laboratory can trace the samples to each of the satellite and/or

contract labs where the tests were performed.

Use the Continuation Page if additional space is needed.

Field 5: NAME AND ADDRESS OF THE INSTITUTIONAL REVIEW BOARD (IRB) THAT IS RESPONSIBLE

FOR REVIEW AND APPROVAL OF THE STUDY(IES)

Use the Continuation Page if additional space is needed.

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.

Use the Continuation Page if additional space is needed.

Field 7: NAME AND CODE NUMBER, IF ANY, OF THE PROTOCOL(S) IN THE IND FOR THE STUDY(IES)

TO BE CONDUCTED BY THE INVESTIGATOR

List the names and code numbers (if any) of all the protocols under the IND that will be conducted by the

investigator signing the Form FDA 1572. A code number is an identifying number assigned by the sponsor.

Field 8: PROVIDE THE FOLLOWING CLINICAL PROTOCOL INFORMATION

Note: Only one box may be selected.

For a combined Phase 1/2 investigation, check only the second box.

For a Phase 4 post marketing clinical trial, check only the second box, and state in Field 7 that the study is a

Phase 4 study.

Field 9: COMMITMENTS

Field 9 contains important commitments that the investigator agrees to by signing the form. The investigator

should sign the form only after being given enough information to be informed about the clinical investigation

and to understand the commitments described in Field 9. Having enough information about the study typically

means that the investigator has received copies of, has read, and understands the protocol and investigator’s

brochure (if required), and is familiar with the regulations governing the conduct of clinical studies.

Field 10: DATE

Enter the date that the form is signed by the investigator.

FORM FDA 1572 SUPPLEMENT (7/13) – FORM INSTRUCTIONS

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Instructions For Filling Out Form Fda 1572 - Statement Of Investigator Page 2