Trial Master File (TMF)
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A Trial Master File (TMF) is an document set for a clinical trial as required by clinical study regulatory requirements.
- Context:
- It can range from being an Electronic TMF to being a Physical TMF.
- ...
- See: Good Clinical Practice, Audit Trail.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Trial_master_file Retrieved:2022-1-3.
- In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
2021
- https://cdsatoolkit.thsti.in/trial-master-file-tmf/
- QUOTE: 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). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. ...
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.)
- Training documentation for trial team
- Details of the laboratories, if applicable.
- Contracts, agreements, budgets, etc.
- Monitoring visit reports (for each site visit onsite or central)
- Documents related to the safety reporting
- Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
- Site specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
- Audit related documents, if available (if an audit was conducted).
- Significant communications
- QUOTE: 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). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
2020
- (Rupani, 2020) ⇒ Zainab Mehboob Rupani. (2020). “Clinical Trial Master File Migration: A Preordained Step for a Centralized Electronic Trial Master File.” Perspectives in Clinical Research 11, no. 4
- ABSTRACT: The need to speed up clinical trial processes in a cost-effective manner, increased importance of data integrity, and ensuring timely compliance to regulatory requirement updates regarding the Trial Master File (TMF), has made the pharmaceutical industry delineate the requirement to maintain a centralized TMF with quality control. With the exponential increase in the number of sponsors using centralized electronic TMF (eTMF), the shift of trend positively impacts the need for data migration requirements in the TMF space. With an objective to serve the readers handling migration projects, this review article discusses the data migration requirements in clinical operations and eTMF in clinical trials, possible techniques to consider avoiding anticipated roadblocks, and a few other key points. The article also focuses on steps to be taken post migration to ensure meeting the quality of the migrated data in terms of regulatory compliance.
- KEYWORDS: Data Migration, Drug Information Association Reference Model, International Conference on Harmonization Good Clinical Practices, Medicines and Healthcare Products Regulatory Agency, Quality, risk-based approach, Trial Master File.