SOP Update
05.31.2023
Modification to the CIRB SOP’s Unanticipated Problems and/or Serious or Continuing Noncompliance and Translation Policies
MEMORANDUM TO FILE
To: CIRB Regulatory File
From: Jenny Morris MS, MBA, CIP
Director of Central Operations; NCI CIRB Operations Office
Date: May 31, 2023
Subject: Modification to the CIRB SOP’s Unanticipated Problems and/or Serious or Continuing Noncompliance and Translation Policies
An updated version of the CIRB SOPs is now available on the CIRB website.
If you have any questions regarding the changes to the SOPs, contact the CIRB Helpdesk.
An overview of the changes to the SOPs is detailed below.
Unanticipated Problems and/or Serious or Continuing Noncompliance Policies
- Section 8.14 – Made editorial changes throughout.
- Section 10.0 – Made editorial changes throughout.
- Section 10.2.5.3.1. – Specified that events will be reported using IRBManager.
- Section 10.2.7.2.2 – Specified that the Chair, Vice Chair, or designee may assign the preliminary review to a CIRB Operations Office staff member who will present their review during the convened CIRB meeting.
- Section 10.3.6.3 - Specified that the Chair, Vice Chair, or designee may assign the preliminary review to a CIRB Operations Office staff member who will present their review during the convened CIRB meeting.
- Section 10.6.2.4 – Added “All applicable Federalwide Assurances (FWA)” to the list of information that should be included in the submission.
- Section 10.6.3.5 – Added “All applicable Federalwide Assurances (FWA)” to the list of information that should be included in the submission.
Translation Policies
- Section 5.9.9 – Updated to clarify for consent forms, PROs, and other patient-facing document translations. Updated to include different types and reviews of the different types of translations based on type of document, source of document, and source of translation.
- Section 7.8 – Clarification to the expectations for use of the Spanish consent forms provided on the CTSU website.
- Section 7.8.3 – The section Translation of Participant Direct Instruments has been removed with the information being incorporated into section 5.9.9.
Changes to this policy as noted above are effective immediately.