This supplement, along with an RNI submission in Hutch IRB, is used to report new information, such as a noncompliance event or an unanticipated problem involving risks to subjects or others, about an approved study or active research to the IRB.
HRP-255 - FORM - Reportable New Information (RNI) Supplement
Document Details
| Version | Effective Date | Change Notes |
|---|---|---|
| 4.00 | 1/1/2025 | Updates related to new short form translation process. |
| 3.00 | 3/4/2024 | - |
| 2.00 | 6/5/2023 | Added Investigator Statement and Signature block. |
| 1.01 | 5/1/2023 | Minor correction of a typo. |
| 1.00 | 2/27/2023 | New form to support Hutch IRB. Replaces Expedited Reporting Form for Unanticipated Problems or Noncompliance (0203) |