During recent audits a deficiency has been noted in how teams submitting eProtocol modifications note what changes are included in the modification. This has resulted in IRB Approval Letters with no mention of what was approved, which makes monitoring and auditing studies more time-consuming.
The IRB provides a text field on the Obligations page of the eProtocol application. This text field will be printed on the IRB Approval Letter after the word “Includes:” As a best practice, please utilize this text field when preparing IRB submissions to denote the following items:
- List of all files attached during the modification (Sections 13, 14 & 16). Use the following naming convention: document name and number (i.e. protocol #, IB #, ICF, etc.), version number (if available), and date.
- Personnel changes (include whether added or removed)
- If an ICF was attached, include statement about who will be re-consented
- Re-consenting might be required for patients on active treatment or follow up.
- Re-consenting under the following circumstances is not required:
- — Changes to the study team not the PI.
- — Typographical errors noted in the consent document unless the error significantly changes the intent of the sentence.
- For an initial application, include statement if short form consent process or wavier of authorization for chart review were submitted
- If additional documents are attached during an IRB comment cycle, update the text field on the Obligations page.
If you have any concerns or questions about preparing eProtocol applications, please consider attending one of the monthly CCTO Orientation Session 3 courses hosted by CCTO Regulatory staff (STARS code: CCTO-0003). You may also submit a request for regulatory services through the new REDCap intake system, and a CCTO Regulatory specialist can prepare the IRB application or modification on your behalf.