TMF: The Foundation of Clinical Trial Project Management
The trial master file (TMF) is at the core of clinical trial project management. The TMF clinical trial project management capability of MasterControl CQMS allows a user to plan their TMF documents and tasks as a projects and provides automated task reminders and updates as tasks are executed and promoted through various lifecycles.
MasterControl CQMS provides essential tools for clinical trial project management that cannot be found in any other single solution, specifically:
- A sample project plan template based on the DIA Reference Model, the ultimate TMF standard. Using this model increases efficiency and provides a central location for all required TMF content.
- Integrated project tasks (i.e., documents, processes, etc.). When integrated and automated, quality tasks can be executed and closed out efficiently for increased compliance.
Simplifying and Streamlining Clinical Trial Project Management
Site documentation and trial eligibility information from hundreds of sites for various clinical studies can create massive clinical trial project management headaches. With MasterControl's clinical trial management software system, each clinical site's information and documents can be linked, searched, and reported on. This information includes facilities, equipment, past trial participation, and audit history as well as site- and study- specific documents.
The MasterControl CQMS also eases clinical trial project management burdens because it provides mobile access to the system. External and mobile users can quickly access information critical to their roles (think: monitors, auditors, or investigators) and can also accelerate the flow of information and execution of clinical trial project management tasks, which reduces cycle times (i.e., reviews, approvals, and training).
Additional Solutions Provided by the MasterControl CQMS
TMF Document Management
- Document Types, Metadata, and Taxonomy based on the Drug Information Association’s (DIA) Trial Master File (TMF) Reference Model
- Workflows: Routes, Collaboration, and Electronic Signatures
Clinical Quality Event Management (Process Management)
- Study Monitoring (Initiation, Intern & Closeout Monitoring), Protocol Deviation and Clinical CAPA Process Management
Clinical Study Management
- Study Information, Project and Timelines
Clinical Vendor (Partner) Management
- Clinical Vendor Qualification (CRO, etc.)
- Clinical Vendor Relationship Management
Clinical Site Management (Site Qualification and Relationship Management)
- Site Information (Facilities, Equipment, Audit History) and Documentation
- Investigator Site File (ISF) Management
- Site Qualification and Risk Based Selection Criteria
Complete Clinical Audit Management
- Vendor, Study and Site Audit Management
Training Management (GCP and Study Training)
- Study Team, Partners/Vendors, Study Site Training
- Risk based Configurable Study Training
- Access Documents, Processes, Tasks, and Training Courses from tablets or smartphones.
Clinical Risk Management
- Project Risk - Study Timeline, Tasks Overdue, Completion Percentage
- Clinical Procedure - GCP Documentation, Patient Enrollment, Safety, Data Integrity, Product Accountability / Storage, CAPA/ Deviations (Volume, Frequency, Trends)
- Vendors/Partners – Risk-based Vendor Qualification/Selection
- Sites - Risk based study site Qualification / Selection
- Audit - CRO and Site Audits: Violation, Finding, Deviations, Follow-up / Corrective Action
- Training - Completed, Outstanding, Overdue
For More Information about Clinical Trial Project Management
For additional details about the clinical trial project management system available from MasterControl, please contact MasterControl representative.