What is trial master file reference model?
What is trial master file 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 Reference 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 documents are in a trial master file?
Includes site selection, set-up, initiation, management and general information. Consists of safety documentation, trial status reporting and general safety reports. Includes oversight, capture, database, electronic data capture management and general data management sections.
What is a trial master file in clinical research?
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.
Who maintains the trial master file?
Sponsor
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.
Who is responsible for TMF?
The TMF is made up of a Sponsor TMF (held by the Sponsor company) and an Investigator TMF (sometimes referred to as the Investigator Site File (ISF) (in possession of the Investigator/Institution). Investigators are responsible for certain documents, while Sponsors are responsible for others.
What are ICH-GCP guidelines?
The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
What are the 13 principles of ICH-GCP?
Ethics.
What is a trial master file specialist?
The Trial Master File (TMF) Specialist will report to the QA/Regulatory Manager, and is responsible for managing the life-cycle of TMF activities for all ongoing and new ADCS clinical trials.