Why the Trial Master File is Becoming Critical to ISO14155 (Annex E) Requirements
With the FDA and EMA requiring clinical investigations for Class III devices (and for Class IIb implantable devices in the EU), the Trial Master File (TMF) is becoming a valuable component in regulatory pathways for medical technology.
To maintain compliance with ISO14155:2020 (Annex E), medical technology companies must retain “essential clinical investigation documents.” Companies are turning to the well-established parameters of the Trial Master File (TMF) to provide an impartial “story” of the conduct of clinical investigations – especially for pivotal trials given the added complexity and size of these studies.
With the Trial Master File, medical technology companies and regulators have a standardized methodology to determine that Good Clinical Practice (GCP) has been followed over the course of the trial - helping to identify potential problem areas early and streamline the approval process.
Incorporating Medical Device Processes & Terminology
The CDISC TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.
To make the model more universal and applicable to medical technology clinical investigations, the model has been incorporating device-specific content.
Examples applicable to clinical investigations include:
- Product and Trial Documentation - Clinical Investigation Plan
- Clinical Study Report - Form FDA 3654
- Investigators Agreement
How Phlexglobal Helps Ensure Clinical Document Compliance
As the global authority in Trial Master File technology and services, Phlexglobal can provide expert guidance and support to comply with ISO14155:2020 (Annex E) requirements for retaining essential clinical investigation documents.
Click on the links below to discover how Phlexglobal can help you streamline approvals and reduce compliance risk.