Traditionally, a trial master file (TMF) has been thought of as a collection of documents to be collated to satisfy the regulatory requirements of a clinical study. While this is still the case, today’s increasing use of electronic TMFs and integrated clinical systems is giving the industry a more holistic and real-time view of clinical trial activities.
As such, regulatory bodies now expect a TMF to be the story of “how the trial was conducted and managed.”
Migrating eTMF documents within systems is not an easy task. Migration is much more than mapping document types and artifacts, and harmonizing the metadata.
DIA is proposing a universal mechanism for document transfer, which is referred to as eTMF Exchange Mechanism Standard (EMS). The preliminary version was released by DIA at its global meeting in Boston in June 2018, so let’s take a look at the background and specifications of this important development.
The new EMS standard will become a major milestone, helping resolve major issues the industry faces when trying to migrate from one platform to another. It will also facilitate the exchange of eTMF content between CRO organizations and from one system to another. The standard includes a specification document, Exchange.xml and Exchange.xsd. (schema for validation of XML format). The schema for exchange is currently in the development phase.
The model specifies different tags required to encapsulate files and metadata values, individual objects, artifact files, electronic signature displays on artifact files, and audit trail entries for artifacts being exchanged.
The eTMF-EMS process operates between two different systems. The originating system produces the output of artifacts within a predefined folder structure with an Exchange.xml file, which further undergoes validation with the help of the Exchange.xsd schema. When the target system imports the Exchange.xml file, it performs the same validation checks, imports all artifacts, and files them under relevant TMF artifact number within the system.
When it comes to implementing EMS, there are a few potential scenarios:
- Study or Contract Closure: Final eTMF transfer to sponsor from CRO for archiving
- Merger and Acquisition: Migration of eTMF content
- Platform Change or System Upgrade: Migration eTMF documents
Today, companies understand the value of compliant and inspection-ready TMF documentation throughout the clinical development lifecycle — and it has become critical to keep these documents ready as and when required for smoother market access.
In the next installment, we will shed a little more light on EMS and discuss a few interesting use cases and best practices for implementing EMS within your organization. Stay tuned.