Prior approval by NIGMS is required before initiating CTR post-award projects (Pilot, Developmental, and/or Multi-Site Collaborative Projects) that are supported with NIGMS CTR funds, regardless of whether the research involves human subjects (HS) or vertebrate animals (VA). All instructions outlined in the “Post-Award Program Requirements for Pilot/Developmental/Multi-Site Collaborative Projects” section of the NOFO applicable to your application must be followed.

Failure to submit the required documentation and obtain prior approval before initiating a post-award project may result in compliance enforcement actions. The Authorized Organization Representative (AOR) will receive confirmation from NIGMS that the required documentation has been received. NIGMS staff will provide feedback within 30 calendar days of submission. Once all required documentation and/or any additional requested information has been received and reviewed, the NIGMS Grants Management Specialist (GMS) will issue an approval email to the AOR, copying all relevant parties.

Notes:

• CTR post-award projects that are not supported with NIGMS CTR funds do not require prior approval, regardless of the type of research.
• In accordance with NOT-OD-26-032, here are ways to determine whether your project is a Clinical Trial, Basic Experimental Studies Involving Humans (BESH), or an Observational Studies Involving Humans.

Addendum and Streamlined Submission Process

NIGMS is streamlining the required documentation and submission process for post-award projects. To support this effort, NIGMS provides an Addendum, in a suggested format, that contains the information required for submission. A fully completed Addendum table constitutes a simplified and strongly encouraged method for ensuring compliance with NOFO requirements.

Updated CTR Post-Award Project Addendum

Notes for Addendum:

• Instructions for each column within the Addendum are available by hovering over the column title. Instructions will appear as a yellow note. 
• When submitting the Addendum, please do not change the column names or their order. 

• Awardees submitting multiple projects at the same time should use one addendum. If additional projects are submitted at a later date, awardees should use a new addendum. 

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Submission Requirements

For projects involving HS or VA research:

• In accordance with NOT-OD-26-026, all required documents, including the Addendum, when applicable, must be submitted through the eRA Commons Prior Approval Module, effective February 20, 2026.
• If an Addendum is included, awardees must also email the Addendum to the Grants Management Specialist (GMS) and the Program Officer (PO) assigned to the parent award, with the complete grant number included in the subject line.

Comments and questions about this Process?

Please contact your assigned Program Officer with any questions.