May 2018
Regulatory Submission Portal Updates
With the implementation of Uniform Document Posting (UDP), the location of documents has changed for CIRB-reviewed studies. In December 2017, UDP was implemented to comply with a new requirement to ensure a single version of CIRB-approved protocol documents. Lead Protocol Organizations (LPOs) are now required to link to the CIRB-approved protocol documents housed on the CTSU members’ website.
To better accommodate this requirement and the posting of documents for CIRB reviewed studies, the CTSU released a new protocol page design for protocol documents. The CIRB Documents tab has become the primary tab for each protocol and is the location for all CIRB-approved documents, such as the protocol, amendments, consents (and translations/certificates), and patient materials. For NCTN studies that are open for cross-network participation, all other LPO documents that are not CIRB-reviewed are located in the Supplemental Documents or other applicable tabs, these include items such as general LPO memoranda/communication, DSMB reports/study summaries, CRFs, and site-focused educational materials. For NCTN studies that are not open for cross-network participation, all other LPO documents are located on the LPO’s website.
The CTSU has developed a handout to outline the types of documents affected by UDP, and provide a detailed listing of documents and their locations. We encourage you to use this resource as you learn to navigate the new organization of the protocol document tab for your studies.
To better accommodate this requirement and the posting of documents for CIRB reviewed studies, the CTSU released a new protocol page design for protocol documents. The CIRB Documents tab has become the primary tab for each protocol and is the location for all CIRB-approved documents, such as the protocol, amendments, consents (and translations/certificates), and patient materials. For NCTN studies that are open for cross-network participation, all other LPO documents that are not CIRB-reviewed are located in the Supplemental Documents or other applicable tabs, these include items such as general LPO memoranda/communication, DSMB reports/study summaries, CRFs, and site-focused educational materials. For NCTN studies that are not open for cross-network participation, all other LPO documents are located on the LPO’s website.
The CTSU has developed a handout to outline the types of documents affected by UDP, and provide a detailed listing of documents and their locations. We encourage you to use this resource as you learn to navigate the new organization of the protocol document tab for your studies.
Document Location in the Protocols > Documents Tab
Announcing the demise of the CTSU fax machine