A Checklist For Good TMF Health

By Amruta Patil and Eva Matheu, TMF Consultants, TransPerfect Life Sciences

The Trial Master File (TMF) serves as the central repository of documentation, playing a pivotal role in upholding regulatory compliance and validating the integrity of a clinical trial. Key qualities defining a healthy TMF include completeness, timeliness, and quality.

In addition, a TMF must encompass several essential documents stipulated by regulatory authorities and Good Clinical Practice (GCP) guidelines, such as the protocol, investigator brochures, informed consent forms, case report forms, monitoring reports, and correspondence with regulatory bodies, among other forms of documentation.

In this guide, the authors have designed a concise checklist compilation of vital factors to ensure the robustness of a TMF. Each aspect addressed herein will bolster the timeliness, completeness, and overall quality of a TMF, adhering to industry standards and best practices.

Access the guide below to better concentrate on critical considerations and safeguard the well-being of a TMF.