Introduction to TMF (Trial Master File) from a Global Perspective (Workshop with Certification)
The conduct of a clinical trial is governed closely by stipulated regulations and regional bodies world-wide such as the FDA in the United States and EMEA in Europe. Regional regulatory bodies such as those in Japan, ascertain compliance from a Japanese-GCP perspective and not ICH-GCP. Pharmaceutical companies or CROs that are involved in the conduct of clinical trials across these regions should be aware of such global and regional cGCP compliance regulations. Stipulated documentation is required to be filed before, during and after the conduct of clinical trials (Trial Master File) for review by the FDA or the regional agencies where the trials are being conducted. In this context, this training addresses requirements related to essential documents that need to be generated according to cGCP procedures.
The course covers issues that are basic such as the required documents that should be on file before a clinical trial starts. It also covers other specific documents to be filed to fulfil all global regulatory requirements. In our efforts to serve this vital area in clinical operations, we offer in-house workshops related to the specified ICH guidelines. The workshops are offered by our distinguished Ph.D-level clinical research faculty. The instructional material contains relevant presentations, example scenarios and a comprehensive module-based assessment of students. We make an effort to keep up with the current ICH-guidelines.
This is the starting point for those who would like to be introduced to the area of global clinical research and management of local/global clinical trial segments.
Junior/entry level pharmaceutical employees, Clinical Research Associates (CRAs), Drug Safety, Regulatory and Clinical personnel, Clinical Study Coordinators, Principal Investigators, Statistical Data Managers, Regulatory Submission System Managers
At the conclusion of the course, participants will be able to have a good understanding of the following:
- Knowledge of planning issues and principles behind the design and organization of TMFs.
- Knowledge of planning issues and organization of TMFs for multi-center CTs (NA, EU, Japan, Asia-Pacific, etc.)
- cGCP and regulatory FDA implications the drug approval process
- Improving decision making for investigators, auditors/inspectors/reviewers and approvers during management of the entire clinical trial process.
- Collective TMF divisions, possible roles and responsibilities on Trial Master File planning/division into sections; maintenance tips from trial initiation to conclusion.
- Tips to synchronize business processes with available technology for filing of TMF related documents. How this translates into an eTMF?
- Benefits and ROI for TMF synchronization with your eCTD/Submissions Management System
The participants will be certified that they are knowledgeable in cGCP/TMF from a Clin Ops perspective. This is a workshop style, whole day class with assessment of students for each module. Students obtaining 75% and above will be eligible for certification.
Topics of Study
Topics include an in-depth instruction of the following:
- Overview of drug development processes and the principles of cGCP (also covers key personnel in clinical research and basic medical terminology).
- TMF from a global perspective (US, Europe, Japan, Asia-Pacific, etc.)
- Design and maintenance of a global TMF repository: responsibilities of personnel (clinical research associates (CRAs), data coordinators, data entry staff, investigators, biostatisticians, etc.) within clinical trials
- FDA’s GCP (Good Clinical Practice) to cover all essential documents and meta-data that should be associated with a TMF.
- Document requirements before the commencement of a clinical trial: What
- should be done to accommodate global clinical trial management issues, participating countries, etc. The procedure and processes to file and maintain necessary documentation
- Address document requirements during the conduct of the clinical trial. The procedure and processes to file and maintain necessary documentation
- Address document requirements after the conduct of a clinical trial. The procedure and processes to file and maintain necessary documentation
- Legacy documents and document destruction practices
- TMF and eCTD relationship: The organization of documents such as those related to Regulatory and Clinical areas in the ICH-9 specified eCTD format and their relationship to TMF structures
- Tips to avoid duplication of clinical trial documentation in multiple trial sites worldwide (NA, EU, Japan, etc.) and the necessity to create a central TMF repository
- Accessing the most current versions/copies of clinical trial documentation (Protocols, Clinical Study Reports, Summary Documents, Investigator Brochures, etc.)