Clarification of the Unified Document Posting Initiative
Dear CIRB Stakeholders,
A notification regarding the CIRB Unified Document Posting (UDP) initiative was issued on December 15, 2017. In response to the UDP initiative and as part of ongoing quality improvement efforts to reduced timelines and eliminate redundancy in postings, the CIRB Operations Office made changes to the document posting process. Based on the nature of the questions received in response to the notification, further information/clarification is provided below.
CIRB Unified Document Posting
As of Friday, December 15, 2017, CIRB-approved study documents will be posted only to the CIRB Documents tab of the CTSU website. Documents posted to other tabs such as the Supplemental Documents and Adverse Event tabs will not be duplicated under the CIRB Documents tab. Other pages and websites on which these documents were previously posted now link to the CIRB Documents tab.
The documents commonly posted to the CIRB Documents tab include the protocol, consent form(s), amendment and continuing review change memorandums, CIRB Applications, CIRB approval letters, and participant facing documents such as Quality of Life Questionnaires.
Other changes that may impact you include:
Routine activities that are conducted per protocol, such as initial and amendment activations and routine status changes, will no longer be acknowledged by the CIRB. If the status change or event is associated with significant new findings or information that may impact a participant’s willingness to continue in the study, such as study closures associated with participant safety issues, the CIRB will post an Acknowledgement or another review outcome, as appropriate.
Participant letters issued directly to sites by coordinating groups to communicate emergent issues to participants and posted to the Supplemental Documents tab will be acknowledged by the CIRB but not duplicated under the CIRB Documents tab.
• Supplemental Documents
Supporting documents provided to the CIRB for reference, such as Data Safety Monitoring Board (DSMB) reports and study summaries, will be posted by the coordinating group under the Supplemental Documents tab or other relevant tab and not duplicated under the CIRB Documents tab.
The coordinating groups are responsible for the posting of Supplemental Documents and questions about these documents should be directed to the appropriate coordinating group. Please note that COG does not yet comply with this policy but will in the coming months.
Please contact the CIRB Helpdesk at NCICIRBContact@emmes.com or at 1-888-657-3711 with questions or for further information. As always, we welcome your comments and suggestions. Revised standard operating procedures (SOPs) will be released shortly and in the interim this notice is documentation of the changes.