Complion (eRegulatory Binder)
- emily.oehler (Unlicensed)
- Dakota Gallimore
- Sullivan, Stephanie (Stephanie) (Unlicensed)
Complion is a 21 CFR Part 11 compliant electronic regulatory system, that allows users to maintain regulatory documents in a safe electronic environment. An eRegulatory system such as this enables real-time regulatory compliance and risk-reduction in study startup, monitoring, audit, inspections, and closeout.
Documents and electronic logs (such as the DOA log) can be uploaded and signed electronically with the use of a signing password set within each login session.
User accounts are requested by the consortia to their designated DMCC project manager. Once access has been created, The Consortia's project manager then assign them to the appropriate binders for their site.
More information on Complion can be found on the Complion Website.
More in depth training created by Complion can be accessed for those with a Complion account.
Because of the potentially sensitive nature of the documents within Complion, RDCRN users are required to use Duo Two-Factor Authentication for RDCRN before being granted access to the application.