What is a TMF Reference Model?
The Trial Master File (TMF) Reference Model is a supported initiative of the Drug Information Association’s (DIA) Document and Records Management Community and represents a single, unified interpretation of the regulations and best practices related to Trial Master Files that would be accepted by all clinical trial …
What is the DIA model?
The DIA TMF Reference Model allows organizations to effectively compile the minimum list of essential documents that will serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements.
What is metadata in TMF?
Metadata refers to information that describes certain characteristics of a file, document or record rather than information that is contained within the record content itself. In the context of the TMF Reference Model, metadata might also include study number, country, document language.
What is the TMF index?
The TMF Reference Model is an industry-adopted reference structure for the TMF that takes the form of an index. Think of the TMF Reference Model like the taxonomy that biologists use to classify all the various types of life on Earth or the Dewey Decimal System that helps keep books organized in a library.
What is a TMF plan?
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit).
What is TMF management?
The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol.
What is a TMF artifact?
3.1.2 Artifacts. Artifacts are collections of information presented in records, documents or data that one would expect to find in a TMF, at both Sponsor and Investigator site.
What should be filed in TMF?
Ideally, the documents included in the TMF are:
- Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
- Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
What is the role of TMF?
A Trial Master File (TMF) is a compilation of documents that prove that the clinical trial has been conducted following regulatory requirements (including Good Clinical Practice). The TMF plays a crucial role in ensuring that the trial has been managed successfully by the Investigator, Sponsor and Institution.
What is included in a TMF?
Why is a TMF plan important?
The reason why the TMF is so important is that it permits the study to be independently recreated from these study records. TMF is a quality process, allowing to document all of the activity that has been performed during the study.
Who owns the TMF?
TMF Group Holdco B.V.
TMF Group/Parent organizations
Is the TMF Reference Model A DIA document?
The TMF Reference Model was developed under the auspices of the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.
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