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Does your CCTS pilot involve human subjects?
- Acquire IRB approval as soon as possible
- If you proposed an NIH-defined clinical trial:
- Notify NCATS of your project and its regulatory approval via an NIH Prior Approval. This NIH Prior Approval is equivalent to completing “Just-in-Time” requests for additional information before a grant will be awarded. The requested information is submitted to NCATS using an NCATS Addendum that is submitted as part of a PHS Human Subjects and Clinical Trials Information study record.
- NCATS Human Subjects Addendum Instructions
- PHS Human Subjects and Clinical Trials Information Form
- Annotated Form (see pages 31-37)
- Video Instructions (6 minutes)
- PHS Human Subjects and Clinical Trails Information Attachments
- Your Human Subject Research protocol,
- If you proposed an NIH-defined clinical trial:
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Does your study involve vertebrate animals?
- – Acquire IACUC approval as soon as possible.
- – Notify NCATS of your project and its regulatory approval via an NIH Prior Approval. This NIH Prior Approval is equivalent to completing “Just-in-Time” requests for additional information before a grant will be awarded. The requested information is submitted to NCATS using an NCATS Addendum.
- NCATS Vertebrate Animal Addendum