In clinical research, the trial master file (TMF) index ensures essential trial documents are organized, easily accessible and compliant. Life sciences organizations are faced with two options: customize their TMF index or follow the standard developed by CDISC.
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that consists of experts from around the globe who are developing and advancing data standards for clinical research. Originating with the Drug Information Association (DIA), the TMF Reference Model (RM) is now fully owned and maintained by CDISC. It’s a standard that all organizations should adopt.
Although many TMF indexes align with the CDISC TMF RM, some companies choose to deviate from the standard. Some deviate a little, and some deviate a lot. Let’s take a look at the three reasons companies deviate from the standard and why it’s best to scrap that custom TMF index.
Reason #1: The CRO Has Their Own Index
Outsourcing to a contract resource organization (CRO) can be a great way to upscale capabilities, particularly for those sponsors just getting started. The difficulty comes when a CRO prefers or even requires you to use their electronic trial master file (eTMF) and, therefore, their system-configured TMF index. In the future, if a sponsor chooses a new CRO or decides to bring their eTMF in-house, it would introduce challenges with the transfer of existing content.
Before selecting your partner, ask your prospective CROs if their index aligns with the latest CDISC TMF RM.
Reason #2: Process Relics From Paper TMF Days
Outdated indexes have artifacts to cover process oversight documentation, which could be better tracked today via a validated clinical trial management system (CTMS). For instance, a custom artifact for a List of Regulatory Authorities and their Initial Approvals might have been something that was once required to be tracked manually and, therefore, may have an SOP requiring its placement in the TMF.
With a modern CTMS, many of these needed insights are a quick report away, so the need for manual trackers would be obsolete. The best solution would be to revise any SOPs requiring the filing of the report in favor of real-time reporting in a validated CTMS.
Even if an organization still did want to file a periodic output of the report, the TMF RM already has a zone-specific general artifact that would suit the purpose. In the example custom artifact above, this would be classified as the artifact Regulatory->General->Tracking Information.
Reason #3: Trying to Gain Control of Completeness With Extreme Granularity
One mistake companies make in an attempt to gain a picture of TMF completeness is to break apart each artifact into many custom artifacts. Counterintuitively, adding a large number of custom artifacts increases the risk of inconsistent filing. It takes a long time to train new team members on an index that can reach complexities of over 1,000 total artifacts. Errors will be made, and the picture one hopes to gain will be obscured by those errors.
The artifacts of the TMF RM should be thought of as process containers. In other words, each artifact contains all evidence of a process being followed, regardless of a document’s title. An example would be the TMF RM artifact “Informed Consent Form” containing both the ICF itself and any internal ICF approval checklists.
Why Should a Company Standardize to the CDISC TMF Reference Model?
Standardization makes it easy for organizations to speak the same language in regard to their data records (documents). Acquisitions and mergers are a breeze if both organizations use the TMF RM. Moving from your old eTMF to a new eTMF system would be relatively painless.
Relying on the expertise of the CDISC TMF RM Committee means that there is no need to reinvent the wheel. You can be sure that the TMF RM can be adapted to all study types with some internal planning to determine the best fit for company-specific documents. If you need additional help, work with a team of clinical experts who can show you how to fit your current index into the latest TMF RM while considering company-specific needs.
Adhering to the CDISC TMF RM is pivotal for organizations engaged in clinical research. While deviations from this standard may seem tempting for various reasons, it’s evident that maintaining a custom TMF index can lead to complications and inefficiencies. Embracing the established standard ensures you can confidently navigate the evolving landscape of clinical research with a robust and universally recognized framework.