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Replace Data into the Sponsorship Commitment Form

Replace Data into the Sponsorship Commitment Form and eSign it in minutes

Aug 6th, 2022

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Got questions?

Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

Who can use FDP template?

Specifically, the templates must be used between FDP member institutions when the federal award is from a federal awarding agency member of FDP. Use of the templates is also highly encouraged between FDP member institutions when the federal award is from a non-FDP member federal awarding agency.

What is the difference between FDA 1571 and 1572?

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

What is an example of a Subaward?

A subaward may be provided through any form of legal agreement, including an agreement that the pass-through entity considers a contract. An example of a subaward would be a territory being awarded federal funds from a Department of Justice mandatory grant to increase housing assistance for victims.

How long does the sponsor have to keep clinical trial records?

Research Records must be maintained a minimum of three years after the research is completed and the study closed with the IRB. Records may need to be kept longer if other requirements apply. Researchers must comply with the longest applicable standard as described above.

How to fill out 1571 form?

Include the following information on Form FDA 1571: Contact information and mailing address of the sponsor (or sponsor-investigator) IND number, if it has been issued. Serial number (see below) The name(s) of the drug/biologic and the indication being studied. The contents of the submission.

What is an FDP template?

The FDP Subaward templates were designed to expedite review among FDP member institutions under federal assistance awards (i.e., grants and cooperative agreements) supporting a public purpose.

What is the Subaward Amendment?

Amendments to the subaward, such as time extensions, rebudgeting or fund changes are accomplished by an amendment to the subaward. Some changes, such as scope of work or PI may require sponsor approval before an amendment can be issued.

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