Documentation Risk Adaptations in Clinical Trials

A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of investigational medicinal products (see MHRA website to download the paper). Interestingly, the paper includes a section on documentation, including the content of the trial master file (TMF) and retention periods for documentation.

Given that the objective of the paper is to provide guidance in the adoption of risk adaptations to the management of trials, the guidance with regards to documentation is sadly lacking. In the area of retention periods, there is actually no guidance to risk adaptations at all. Furthermore, the paper does not even acknowledge the requirement contained in Directive 2003/63/EC for the sponsor to retain “all other documentation pertaining to the trial as long as the product is authorised“. I would have expected this document to outline the circumstances under which all documentation really needs to be retained for this extensive period and to provide guidance in the circumstances under which it might be considered acceptable to retain documentation for a shorter period of time, for example in relation to trials on established products. The option to destroy certain trial documents only 2 years following marketing approval would have been a significant step forward. Instead, the requirement still stands to retain all documents for the lifetime of the product, a period which bears little relation to patient safety and the statute of limitations.

In relation to TMF content, the paper goes a little further, identifying specific documents which might not necessarily be expected in the TMF for certain types of trials. Unfortunately, the documents cited usually form a very small percentage of the content/volume of a typical TMF so the impact is likely to be minimal. In addition, I would anticipate many sponsors preferring to have a single, consistent policy for TMF content to avoid inadvertently missing content. The paper would have had more impact if it permitted a risk adaptation for ancilliary correspondence, for project management documentation and for QC records such as the evidence of document review and approval. For some trials, these records have minimal impact in relation to verifying trial conduct and patient safety yet would have a major impact on the administrative burden of trial management.

From a records management perspective, this paper is welcomed as it acknowledges the important place that documentation has in clinical trial management. However, the content only begins to scratch the surface. I look with eagerness for an early revision of this document!


About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Compliance, Records management practice, Regulations, TMF. Bookmark the permalink.

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