Trial master file

The Trial Master File, TMF for short, is a filing system and contains essential documents of the clinical trial according to chapter 8 of the GCP. The sponsor is responsible for the filing of all relevant documents as well as their completeness and availability. During inspections / audits, the Trial Master File can be checked by the competent authorities.

The table of contents of the Trial Master File can be created on the basis of checklists with the help of existing SOPs. The checklist TMF describes the essential documents according to ICH-GCP, additionally the documents required for submission to ethics committees and the authorities are listed. The Trial Master File must always be complete, authentic (true or certified copy), immediately available and readable. In the case of an electronic TMF, the system must be validated and contain audit trails. The storage must meet national and EU requirements and be protected against e.g. fire, vermin and water. The sponsor can hand over the storage of the Trial Master File to a company, but always retains responsibility for the quality, confidentiality and accessibility of the TMF.

Only authorized persons may have access to the Trial Master File, which should be specified in the SOP (Standard Operationg Procedure). The TMF contains e.g. the following documents:

• List with the study team (sponsor, study sites, study nurses, biometricians, contract research organisation)
• Signed study plan / observation plan
• Patient information and informed consent
• For AMG studies: EUDRACT-No
• Correspondence with the ethics committee including amendments
• Correspondence with the higher federal authority
• Documents of the Head of the Clinical Trial (LKP)
• Insurance documents
• Documents for data management (e.g. randomisation lists, Case Report Forms)
• Standard value tables (e.g. for laboratory tests)
• Details of the test product (Investigator`s Brochure, technical information)
• For medical devices: CE certification
• Information on logistics
• Information on pharmacovigilance / safety
• Contractual
• Monitoring manuals and monitoring reports
• Centre-specific documents (e.g. confidentiality agreement and signature list)