What is the function of a clinical trial master file?

The clinical trial master file (TMF) plays an essential role in the management and oversight of a clinical trial. Its primary function is to compile and maintain all the essential documents that are necessary for the conduct of the trial. This includes documents related to the trial's design, approval, conduct, and analysis, ensuring that they are organized, accessible, and compliant with regulatory requirements.

The TMF serves as a comprehensive record that allows for effective management of information and provides evidence of compliance with Good Clinical Practice (GCP) standards. By centralizing these crucial documents, the TMF facilitates oversight by regulatory authorities and ensures that all stakeholders, including sponsors, investigators, and monitors, have access to the necessary documents throughout the trial's lifecycle.

In contrast, options related to storing participant personal information, conducting financial audits, or preparing press releases do not align with the primary purpose of the TMF. Participant information is typically kept in separate, secure files to protect privacy, financial audits are part of a different operational process, and press releases relate to public communications, which are outside the scope of what the TMF is intended for. Thus, the compilation of essential documents for the conduct of a clinical trial is the correct function of the clinical trial master file.