Sample trial master file

It is important to note that this TMF Plan Template has been written to cover both sponsor and investigator TMFs but is easy to adapt if your organization has separate, documented procedures for each type of document. The template includes green text which is there to provide guidance to the user on how to best adapt the TMF Plan depending on the type, size, complexity of the clinical trial.

As such, it should be taken as a recommendation on how the template can be used, rather than how it should be used. Users of the template are highly encouraged to adapt the document to complement their needs and to cross-reference internal SOPs or other written procedures rather than duplicating the text within this plan. Includes sections dedicated to trial oversight, the trial team, the trial committee, meeting information, etc.

Sections focused on product and trial documentation, subject documentation, reports, etc. Sections divided into trial approval, investigational medicinal product, trial status reporting and general categories.

Independent ethics committee IEC , and other information on approvals with sections focused on trial approval, other committees, trial status reporting, etc. Includes site selection, set-up, initiation, management and general information. Sections focused on IP documentation, IP release process, IP allocation documents, storage, non-IP documentation, interactive response technology and general information.

Consists of safety documentation, trial status reporting and general safety reports. Sections devoted to facility documents, sample documentation and other general testing information. Includes oversight, capture, database, electronic data capture management and general data management sections. Sections devoted to statistics oversight, randomization, analysis, statistical reports and general statistics.

This complexity is magnified further when contract research organizations CROs are employed to conduct clinical research, since CROs generate and maintain their own collections of documents. Since regulatory agencies do not provide a comprehensive list of each individual content piece required for a compliant TMF, the DIA TMF Reference Model trial master file structure provides a generally accepted framework for TMF-related data, documents, artifacts and activities.

This globally recognized trial master file management plan allows organizations to effectively compile the minimum list of essential data and documentation for regulatory purposes. It's also widely acknowledged as an extension of the Electronic Document Management EDM Reference Model created for biopharmaceutical companies implementing a system to store and prepare documents for regulatory submissions of drugs or biologic products intended for human subjects.

There are many clinical research entities that can benefit from using the TMF Reference Model trial master file structure, including biopharmaceutical and medical device companies, CROs, clinical vendors, or any other organization engaged in the management or execution of study-specific TMFs. Investigators who manage site files or who conduct investigator-initiated studies also may find the TMF Reference Model trial master file structure useful.

As proof of the efficacy and proliferation of the DIA TMF Reference Model trial master file structure within the industry, a recent survey conducted by DIA indicates that 85 percent of industry respondents either currently use the DIA TMF Reference Model trial master file structure, are in the process of implementing it or are considering using it in the future. Regulatory agencies throughout the world require trial master file documentation from clinical research to be filed in submissions.

Note that trial master file structure can vary greatly depending on the size of the clinical trial and the size of the organization conducting the trial, as well as whether the trial is conducted in multiple sites or countries. The Sponsor determines which requirements apply to each clinical trial about to begin, the end dates and whether the trial is used, or intended to be used.

Before any transfer of files, the content of the TMF needs to be checked to ensure that the original archived documents are all accounted for. When the location of the stored TMF has been moved, it needs to be recorded to enable tracking. The Sponsor needs to make sure that the TMF is always available for archive inspections. What is a Trial Master File?

English Korean Chinese, Simplified. AU - Melbourne. AU - Brisbane. CN - Hong Kong. CN - Shanghai. IN - Bangalore. MY - Kuala Lumpur. PH - Metro Manila. CN - Taipei City. TH - Bangkok. NZ - New Zealand. KR - Seoul. KR - Gyeonggi-do. KR - Seoul City Aiport. North America US - Boston. Trial Master File Structure When undertaking a clinical trial, the Sponsor, Investigator and Institution should identify and maintain the locations of the documents needed to complete the TMF.

Trial Master File Contents Essential documents play an important role in evaluating the conduct of the trial and the quality of the data produced. Essential Documents Completed forms, checklists, and reports which have been collected from the trial activities carried out by the Sponsor, Investigator and Institution.

Superseded Documents Documents that have been subjected to revision although the meaning of the document remains the same. Correspondence Pertinent correspondence that reconstructs the activities and decisions that were carried out during the clinical trial need to be included in the TMF. This includes: Any correspondence with ethics committees, safety monitoring committees and regulatory authorities. Sent and received correspondence.

Secure passwords. System in place for locking documents or the TMF to prevent any unauthorised edits.