AAHRPP Sponsored Research Contract Requirements

New Contract Checklist

Contract Execution Date
Sponsor Name
Principal Investigator
Protocol Number
Protocol Title
Standard & Current Version of CT CRADA / Y / N / If NO complete information below
Check boxes certifying requirements are satisfied and state article/section of contract where statement can be found

 The Organization has a written agreement with the sponsor that the Organization will use procedures that protect research participants.

Article/Section: ______

 The organization has a written agreement with the sponsor that addresses medical care for research participants with a research-related injury.

Article/Section: ______

 In studies where sponsorsbear responsibility for monitoring of theresearch, the Organization has a writtenplan with the sponsor that the sponsorpromptly reports to the Organization findingsthat could affect the safety of participants ortheir willingness to continue participation,influence the conduct of the study, or alterthe IRB’s approval to continue the study.

Article/Section: ______

 In studies in which contracts or other funding agreements require the sponsor to send data and safety monitoring plans and reports to the VA facility, the Organization has written agreement that specifies the time frame for providing routine and urgent data and safety monitoring reports to the Syracuse VA Medical Center as indicated in the data and safety monitoring plan approved by the IRB.

Article/Section: ______

 Before initiating research, the Organization has a written agreement with the sponsor about plans fordisseminating findings from the researchand the roles that investigators andsponsors will play in publication ordisclosure of results.

Article/Section: ______

 When participant safety or medical care could be directly affected by study results (open or closed study): the Organization has addressed in the written agreement with the Sponsor how results will be communicated to the researcher or the Syracuse VA Medical Center when those findings directly affect subject safety.

Thewritten agreement specifies a time frame after closure of the study during which the sponsor will communicate such findings (e.g., two years), when appropriate, based on the appropriate timeframe for the study.

Article/Section: ______

______
Executive Director, CNYRCDate

______

ACOS/ResearchDate

Syracuse VAMC R&D Form

Version 11/2011

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