Decoding Double Vision

One of the fundamental principles in Trial Master File (TMF) management is to prevent the duplication of documents. We all recognize that the primary objectives of the TMF are to meticulously document the clinical trial process and safeguard the rights of patients. Equally important is the TMF’s role in facilitating, rather than hindering, the audit process during inspections. Clinical research professionals responsible for creating TMFs should always bear this in mind. Just imagine the frustration an inspector would experience when confronted with repeated instances of identical documents, necessitating their time and effort to determine potential minute differences between them.

But how do we define and handle duplicate documents? While it may seem obvious, there are scenarios to consider:

  1. Corresponding classification and metadata: If a record possesses matching classification and metadata, it could indicate a duplicate document, even if the date is the same. For example, multiple IRB approvals may occur on the same date, but they could be associated with distinct submissions and should be filed accordingly.
  2. Identical time stamps or hash codes: When multiple documents have the same time stamp or hash code, it is highly likely that they are duplicates. However, the reverse is not necessarily true—documents with different codes may still be duplicates if the same document is scanned more than once.
  3. Site-specific relevance: If a particular document is not applicable to all sites, the question arises whether it should be filed once or several times in the eTMF. Ideally, the document should be stored in a single location within the eTMF and linked to the appropriate sites. Similarly, program-level documents such as Investigator Brochures should follow the same approach—filed in a singular location and linked to the relevant studies. For instance, a new version of an Investigator Brochure would not be filed with terminated studies.

The best strategy is to identify duplicate documents at the initial phase of eTMF creation, during the document upload process. Ideally, the eTMF system should be configured to alert the submitter of potential duplicates, allowing them to decide whether to proceed with the upload or cancel it. If the eTMF system lacks this functionality, the submitter may need to manually conduct a quality check for duplicate documents prior to uploading, which is significantly more time-consuming. The least effective approach is visually scanning documents within an existing eTMF, as this practice is prone to errors and cannot be fully and accurately performed until the study concludes and all documents are retrieved and uploaded to the eTMF.

Avoiding duplicate documents in the eTMF necessitates employing best practices, combining technology, developing comprehensive policies and guidance, and providing hands-on training for TMF clinical research professionals. By implementing these measures, we can ensure a streamlined and error-free TMF management process.