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STANDARD OPERATING PROCEDURETrial Master File and Essential Documents Standard Operating Procedure Western Health SOP reference002Version:2.0 dated December 2015Effective Date Review Date Author:Mr

How to fill out trial master file and

How to fill out trial master file and

1. To fill out a trial master file (TMF), follow these steps: 1. Create a dedicated folder for the TMF on your computer or a shared drive.
2. Organize the folder structure according to the TMF Reference Model or other applicable standards.
3. Include essential documents like the protocol, investigator's brochure, informed consent forms, case report forms, and regulatory approvals.
4. Label each document with a unique identifier and version number.
5. Maintain an index or table of contents for easy navigation.
6. Ensure all documents are complete, accurate, and up-to-date.
7. Use section dividers or subfolders to categorize the documents.
8. Regularly review and update the TMF to include new documents or revisions.
9. Keep the TMF organized and easily accessible for audit and inspection purposes.
10. Consider implementing an electronic TMF system for better document management and version control.

Who needs trial master file and?

1. A trial master file is needed for various stakeholders involved in clinical research, including:
2. - Pharmaceutical companies conducting clinical trials
3. - Contract research organizations (CROs)
4. - Investigators and clinical trial site staff
5. - Institutional review boards (IRBs) or ethics committees
6. - Regulatory authorities such as the FDA or EMA
7. - Sponsors and co-sponsors of clinical trials
8. - Monitoring teams and auditors
9. - Quality assurance personnel
10. - Documentation specialists and archivists
11. - Any party involved in the management, oversight, or documentation of a clinical trial.

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What is trial master file?

Trial master file is a collection of essential documents that allows for the evaluation of the conduct of a clinical trial.

Who is required to file trial master file?

The sponsor or the principal investigator is responsible for filing the trial master file.

How to fill out trial master file?

The trial master file is filled out by compiling all necessary documents and records related to the clinical trial in a structured manner.

What is the purpose of trial master file?

The purpose of the trial master file is to provide a complete record of the trial's conduct and to ensure compliance with regulatory requirements.

What information must be reported on trial master file?

The trial master file must contain details of the protocol, study records, investigator information, informed consents, and other relevant documentation.