Discover Our New CTMS
TMF Expert Insights
Thursday, June 8, 2017 | 4:53 PM
The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”
Most of this guidance has been derived from the revised version of the reflection paper on TMF and includes detailed descriptions of content, management, archiving, audit, and inspection of clinical trials along with the latest ICH E6 revision. This guidance is still a draft for consultation, and they are accepting comments until July 11, 2017.
Designed to help sponsors and investigators comply with the requirements of the regulation on clinical trials (medicinal products) and the Trial Master File, the EMA states that “this guideline aims to collate and explain the requirements for the TMF as covered in the Regulation and ICH-GCP E6 to assist organizations in maintaining a TMF that facilitates trial management, GCP compliance, and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and consecutive destruction of paper documentation.”
The guideline covers both the paper and electronic versions of the Trial Master File, taking into account the challenges that an organization might face for implementing the latter. This draft provides detailed standards on how to implement and maintain TMFs that comply with the regulatory requirements. Section 7 of the guidance, “Inspection Readiness of TMF,” also emphasizes the need to ensure transparency, quality, and accessibility.
Some of the key takeaways from the guideline:
With this guideline, the EMA aims to bring together TMF requirements covered in ICH E6 and the regulation to assist sponsors/CROs and other organizations in maintaining an inspection-ready TMF to achieve better trial efficiency.
The draft guideline is available on the EMA website, and is currently open for comment.
Please reach out to firstname.lastname@example.org with any additional questions about the guidance or for information about our eTMF services.