Introduction of the TMF standard
The pharmaceutical and life sciences sectors are both heavily regulated and data-rich which creates a very real problem.
How do you manage your data lifecycle for clinical trials when the data is held in multiple silos; separate departments, organisations or geographies?
Further exacerbating this issue is the strict regulatory requirements to organise your clinical trial data in such a way that it can be accessed for auditing, discovery or inspection purposes in the future. This has led to the creation of the Trial Master File (TMF) Reference Model, a suggested model with standardised metadata and nomenclature references to support collaboration across this industry.
However, the industry has moved on again, with increasing amounts of collaboration across organisations and globalisation of clinical trials making it essential to share documents across organisations and geographies. And a lot of this information is now electronic, creating the eTMF (electronic TMF).
With the launch of the eTMF Exchange Mechanism Standard, there is now a standardised approach to facilitate the transfer of TMF content and its associated metadata. When looking at preserving these reference files into the long term and transferring such data within, or outside of, organisations, the challenge arises when trying to transfer the data to those who don’t support this standard.
Prior to the creation of the TMF Reference Model, there was no universal method for the organisation of trial content documentation and data; the eTMF mechanism is an extension of this.
The new challenge to overcome
There are a number of scenarios in which content (document and data) migration and archiving fail, usually because of the rigidity of the Electronic Content Management (ECM) schema, or issues related to scalability and flexibility and the specific approaches required to create a true archive. These challenges typically present themselves in the following circumstances:
- Trying to migrate multiple schema from multiple trials into a single, unified ECM
- End of life or decommissioning of an ECM / eTMF system
- Sharing the TMF between contract research organisations (CRO) and sponsors using different schema or eTMFs
- Transferring TMF content between partner sponsors or CROs and sponsors
- Combining TMFs from multiple stakeholders
- Maintaining the preservation and legibility of TMF content over the long term with changing regulations and new data schema
- Maintaining the data integrity of TMF content throughout the lifecycle of the content including any changes, moves, upgrades arising from format, software, hardware and operating system changes.
Any long-term data safeguarding solution needs to be able to streamline the interchange of TMF artefacts and metadata (between organisations and systems) to a long-term digital archive, preserving full audit trail and electronic signature information.
However, this standard mechanism only truly works if you have an archive that is flexible enough to receive the transferred content and metadata and able to accommodate other scenarios between different TMF standards and non-TMF metadata schema. Only then will you be able to ensure long-term compliance in terms of accessibility, readability, and searchability.
The Trial Master File Reference Model team
The Trial Master File Reference Model team is composed of representatives from more than 165 biopharmaceutical companies, contract research organisations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, not-for-profit / NGO and regulatory agencies.
However, each body has the flexibility to create its own minor modifications to the model to store content and metadata into a traditional electronic content management system or repository best suited to its needs.
The future…
All ECM based eTMF repositories provide automated methods and workflows to collect, classify, index and report on content. The core of any ECM system is a schema or classification system (such as document tagging terms or metadata) and a relational database that retains eTMF content for search, reporting and other management tasks.
Adoption of the TMF Reference Model continues to rise. Regardless of whether a TMF is based on the TMF Reference Model, every organisation involved in clinical trials maintains a TMF comprising thousands of pages of documents required for regulatory and evidential purposes.
These essential documents are subject to compliance with ICH GCP, FDA 21 CFR Part 11 and other regulatory requirements. The archive has to maintain these documents in a manner that continues to ensure ongoing compliance with these regulatory requirements for as long as they are needed.
In summary, the TMF Reference Model ensures a systematic and consistent structure, hierarchy and metadata for TMF content. The eTMF Exchange Mechanism Standard provides an equally systematic and consistent approach to improve acquisition, migration, transfer of eTMF content from one repository to another further enhancing collaboration across the industry and accelerating eDiscovery and time to market.
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