FDA Form 1572

Question 1:

I had the following two questions regarding the completion of the FDA form 1572:

In case of a protocol amendment: does each participating clinical investigator needs to re-sign a new version, including the titel of the amended protocol?

In case a sub-investigator listed on the FDA 1572 form does not longer participate in the particular study, is a new form without the name of this sub-investigator needs to be signed?

Answer 1:

Your questions to CDER DRUGINFO about updating a Form FDA-1572 (1572) were forwarded to me for a response. You specifically ask if a 1572 must be updated each time a protocol is amended and when a sub-investigator is no longer affiliated with the study.

The 1572 has two important functions. First of all, the 1572 is intended to provide the sponsor with information about the clinical site and investigator qualifications that will enable the sponsor to establish and document that the investigator and site are qualified to conduct the study. The second important purpose of the 1572 is to obtain the clinical investigator's commitment that he/she will conduct the study in accordance with the approved protocol, and will comply with all of the requirements for conducting such studies as set forth in 21 CFR 312, 50, and 56.

Many people are don't realize that the 1572 itself is not required to be submitted to FDA, although in practice, sponsors often submit the 1572 to the IND as an efficient means to provide the information required under 21 CFR 312.23 (a) (6) (iii) (b):

"(b) The name and address and a statement of the qualifications (curriculum vitae or other statement of qualifications) of each investigator, and the name of each subinvestigator (e.g., research fellow, resident) working under the supervision of the investigator; the name and address of the research facilities to be used; and the name and address of each reviewing Institutional Review Board."

As you are probably aware, the sponsor is required to file an amendment to the IND under 312.30 when certain changes are made, including changes in a protocol (that would significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the study (21 CFR 312.30(b)), or the addition of a new investigator (21 CFR 312.30(c)), in which case the sponsor must submit the same information as described above (21 CFR 312.23(a) (6) (iii) (b)). Again a sponsor may elect to provide the 1572 for a new investigator as a means to report this information.

Beyond reporting a new investigator (and the subinvestigators under them) as required by 312.30, I'm not aware of any specific requirement to revise the 1572 when a subinvestigator leaves the study.

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