Trial Master File Audit Checklist

Trial Master Files (TMFs) are essential documents which enable auditors and inspectors to reconstruct and assess clinical trials, helping ensure compliance, accessibility and quality.

TMF management can be complex and one of the primary concerns identified during an MHRA inspection are document related issues. To assist sponsors improve their TMF management practices, we created an exhaustive trial master file audit checklist.

Checklist of Essential Documents
Trial Master Files are an integral component of clinical research. They serve as a repository for essential documents that demonstrate compliance with regulatory requirements, enabling reconstruction in case of audit or inspection.

No matter if you’re managing an electronic or hard copy Trial Master File (eTMF), having an organized checklist that covers all necessary documents is an invaluable way to keep track of things from study initiation to trial completion. With MasterControl’s free downloadable template, managing TMF documents becomes simple!

This template is based on UK specific TMF guidelines provided in JRO/INV/S02/07 and MHRA GCP inspection FAQs, but may not apply to every trial. If any documents do not apply to your study, please indicate it in the comments section. Additionally, there is an essential documents checklist available arranged by category to make this easier to use.

Checklist of Regulatory Documents
Trial Master Files (TMFs) serve as an invaluable resource when overseen by regulatory bodies, providing essential documents like protocol, investigator’s brochures and informed consent forms that need to be included for clinical trials to run effectively. They also contain updates for safety issues as well as communications between trial participants and regulatory bodies.

When a regulatory agency conducts an inspection, their inspector will carefully review these essential and additional documents and records. Being prepared with this documentation will demonstrate your adherence to regulations while speeding up the process.

To ensure all essential and additional documents are available for inspection, it’s essential to create your TMF from the outset with clear policies and procedures in mind. Train all participants involved in your trial on these policies so they know exactly what’s expected of them. A system like Veristat’s real-time document status tracking makes the inspection and audit process easier by making it simple for regulatory officials to quickly locate relevant data.

Checklist of Study Documents
To maintain the integrity of data collected, it is critical that your TMF includes an extensive array of documents. This should include essential, regulatory and study documents (i.e. IRB-approved informed consent forms or medical records).

No matter who inspects a TMF – whether that be an auditor, internal team, the sponsor’s auditor, local regulatory authorities or independent inspectors – its inspection readiness must always be at its peak. To help facilitate this task, the Medicines and Healthcare products Regulatory Agency of the UK recently published a helpful eTMF Inspection Checklist which addresses many key areas for consideration.

Key to creating an audit-ready TMF is using an electronic TMF system designed specifically for clinical operations. Such solutions offer automated tools, flexibility and ease of collaboration that help teams work more efficiently while complying with GCP requirements. For more information, download our free guide: Would Your eTMF Pass an Audit?

Checklist of Sponsor Documents
Essential documents of any clinical trial are those which demonstrate its conduct and compliance with regulatory requirements. Preliminary drafts of essential documents may be prepared prior to trial commencement, while ongoing development might result in new documents created during or at its completion (e.g. analysis codes or DMC closed reports and minutes).

At the core of TMF inspection readiness lies maintaining accurate documentation at all times. This requires keeping all potential documentation identified, documented, and filed; in some instances a sponsor may outsource some or all aspects of managing a TMF to Contract Research Organizations (CRO’s); therefore it’s vital that these CROs have access to any necessary paperwork so that they may meet regulatory obligations effectively.

Sponsor organizations must clearly establish the appropriate level of supervision over their CROs to ensure all required documentation is maintained, which may involve documenting and establishing TMF procedures to facilitate management, exchange, remote access and retention between Sponsor, CRO and sites.