The management of a Trial Master File (TMF) for a clinical study goes beyond simply managing the creation, review and approval of content that is included in a TMF. Each clinical study brings about its own level of documentation, complexity, collaboration, information exchange, milestones and activities which must be managed as evidence of GCP compliance and the scientific credibility of the clinical study. The ability to manage all of the interactions required by all participants and contributors, such as sponsors, CROs, vendors and study sites in a secure and organized manner ensures the completeness, compliance and "audit readiness" of a clinical trial and Trial Master File (TMF).
The MasterControl eTMF Manager™ is an electronic trial master file management solution designed to enable real-time visibility into the status of all activities pertaining to a clinical study. Based on the TMF Reference Model, the eTMF Manager provides management of all documents, tasks, milestones and activities (such as monitoring visits and audits) required during a clinical trial, while allowing both sponsors and CROs to track the progress of pending, ongoing, and completed actions.