Clinical
Trial Master File Checklist
A clinical trial master file (TMF) is an essential collection of the many documents, tasks, milestones and activities that must be maintained as evidence of scientific credibility and proof of a clinical trial’s adherence to regulatory requirements. A trial master file checklist can help ensure that the content required for regulatory compliance is included in your organization’s TMF and that all requisite activities are effectively monitored and recorded.
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Clinical Trial Master File Template Usage
MasterControl offers a complimentary downloadable trial master file template above in Excel spreadsheet format. The TMF template is designed to streamline the management and collection of TMF documentation from study initiation to study closeout. MasterControl developed the TMF template to aid companies that have not yet invested in a TMF management software solution and/or are looking to augment inefficient paper-based TMF processes. It includes a complete listing of all TMF artifacts found in the TMF Reference Model and an explanation of the purpose of each item. The TMF template is based on the TMF Reference Model Version 3.0, which was released by the Drug Information Association’s TMF Working Group in June 2015.
TMF Software Features
A TMF software solution can facilitate the real-time management of a trial master file checklist and improve visibility into the status of all TMF activities. If you’re looking to implement a reliable TMF software solution, there are critical functionalities that must be considered. At minimum, an effective and dependable TMF solution should offer:
- A TMF Reference Model-based trial master file checklist
- A document management configuration of TMF document types, trial master file checklist templates, metadata, version control, lifecycle management, routes and user roles for all TMF artifacts
- A secure collaboration environment for sharing and exchanging clinical trial master file content with both internal teams and external contributors (i.e., sponsors, CROs, study sites, etc.)
- System notifications that are triggered after trial master file checklist milestones have been met and/or when task assignments have been completed
MasterControl and TMF
The cloud-based MasterControl Clinical Excellence™ software solution suite streamlines the management of clinical trial master file documents and tasks and maximizes the connectivity and reuse of clinical research data. MasterControl clinical solutions are specifically engineered to facilitate:
- Streamlined collection and control of TMF documents, artifacts, processes, tasks and site data on a single platform throughout the clinical lifecycle
- Integrated study management
- Seamless harmonization with quality management processes
- Product lifecycle excellence through every stage of your clinical research and product development lifecycle
- Adherence to the TMF Reference Model industry standard configuration
Organizations that have implemented MasterControl are finding that they can decrease implementation times and more easily align with the trial master file checklist configuration recognized by global regulatory agencies. For more information about the trial master file checklist or MasterControl's clinical trial master file solutions, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
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