When To Use NCI CIRB, IRBManager, and CTSU Websites
The NCI CIRB website is the how-to information tool for the CIRB users. The website provides information for local institutional staff, network staff, and members of the individual CIRB Boards, as well as the general public.
Local institutional staff will find helpful Quickguides that explain how the CIRB works, how to enroll in the CIRB, basic information about using IRBManager, and how to complete and submit the required worksheets using IRBManager. Worksheet Quickguides include:
- 1 - Annual Signatory Institution Worksheet
- 2 - Annual PI Worksheet
- 3 - Study-Specific Worksheet
- 3_5 - Change of PI Worksheet
- 4 - Study Closure or Transfer of Study Review
- 5 - Unanticipated Problem and/or Noncompliance Worksheet
- 6 - Requesting an Assent Waiver Worksheet
- 7 - Notification of Incarcerated Participant Worksheet
Network staff will find Quickguides that explain how to complete the CIRB applications for submitting Recruitment Material, Initial New Studies, Amendments, and Continuing Reviews, the types of documents posted to the CTSU website, and CIRB meeting schedules for the four Boards.
Existing CIRB Board members, as well as those who may be interested in becoming a Board member, can find CIRB Standard Operating Procedures, an overview of the CIRB process, and CIRB meeting schedules.
IRBManager is where the work is performed by local Signatory Institution staff. Quickguides for navigating IRBManager are available as a reference. Local Signatory Institution staff use IRBManager for local Signatory Institution submissions of worksheets to receive CIRB approval. Each Signatory Institution has a unique User Dashboard in IRBManager. This User Dashboard allows all CIRB-rostered staff to view all worksheets, whether completed or in-process, submitted under the Signatory Institutions.
For most users, access to IRBManager is controlled through the individual Signatory Institution CIRB Roster in CTSU’s Roster Update Management System (RUMS) and Cancer Therapy Evaluation Program - Identity and Access Management (CTEP-IAM) system. All Signatory Institution staff (PIs, research staff, support staff, etc.) that require access to IRBManager or CTSU should have an active CTEP-IAM account and be listed on the Person Roster in RUMS. All Component or Affiliate Institutions covered by the Signatory Institution should be listed on the Institution Roster in RUMS. The designated RUMS Update Person(s) at each Signatory Institution is responsible for maintaining both the Person and Institution Rosters for the Signatory Institution.
The Clinical Trial Supports Unit (CTSU) website is where Network and local Signatory Institution staff can view study-level determinations made by the CIRB as well as CIRB-approved study documents. The CTSU website also includes access to RUMS and CTEP-IAM.