CIRB Unified Document Posting

Dear CIRB Stakeholders,

As part of ongoing quality improvement efforts, the CIRB Operations Office has made changes to the document posting process in order to improve timeliness as well as centralize the location of CIRB-approved study documents.  These changes eliminate the 24-48 hour lag time between study activation and document posting, as well as limiting duplicative and inconsistent posts.


CIRB Unified Document Posting

As of Friday, December 15, 2017, all CIRB-approved study documents, including the protocol, consent form(s), amendment and continuing review memorandums, and CIRB approval letters, will be posted only to the CIRB Documents tab of the CTSU website.  Other pages and websites on which these documents were previously posted will now link to the CTSU CIRB Documents tab.


Other changes that may impact you include:

•    Initial and Amendment Activation Acknowledgements
CIRB acknowledgements for the initial and amendment activations will be posted to the CTSU website under the CIRB Updates tab associated with that event. The posting will include the date of the activation.

•    Study Status Change Notices
Notices regarding study status changes, including re-activation, closure to accrual, and temporary closure to accrual, will be posted under the Supporting Documents tab of the CTSU website. The CIRB will only acknowledge these status changes if they are associated with significant new findings or if they may impact a participant’s willingness to continue in the study.  Routine activities that are conducted per protocol will not be acknowledged by the CIRB.

•    Continuing Review
Supporting documents, such as Data Safety Monitoring Board (DSMB) reports and study summaries associated with the CIRB’s continuing review, will be posted under the Supporting Documents tab of the CTSU website.  


Please contact the CIRB Helpdesk at or at 1-888-657-3711 with questions or for further information.  As always, we welcome your comments and suggestions. As we receive feedback on this process, we will be posting frequently asked questions (FAQs) on the CIRB website ( Revised standard operating procedures (SOPs) will be released shortly and in the interim this notice is documentation of the changes.

NCI CIRB Helpdesk
NCI CIRB Operations Office
The EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, MD 20850