Does your Trial Master File tell the right story about your study?

Brandy Chittester, Chief of Clinical Operations, IMARC

In clinical research, we often say “If it’s not documented, it’s not done.” Throughout a clinical trial, this adage guides decision-making processes when securing compliance. If a study team member was no longer working on the study, would the rest of the team know what happened well enough to explain?

Having a remote audit of your Trial Master File can tell you the answer to this question. Does the documentation ‘tell the story’ of the study, from outlining the process for choosing sites/investigators, to how the monitoring took place, to the safety oversight activities, to data analyses and ultimately submission of the application? Or, instead, does the documentation have gaps and leave room for questions regarding data integrity or worse, human subject protection?

With experience auditing dozens of Trial Master Files, we are convinced that remote reviews of the documentation are just as valuable, if not more valuable, than in-person reviews. Not only is there an added expense to the sponsor for bringing an auditor (or auditors) on-site for an audit, but generally the study team then has to invest a lot of time and effort into hosting the auditor(s). The outcome of the audit almost always feels personal to that team. Stress levels rise when questions are asked, as study team members wonder whether the auditor(s) is satisfied with what they are hearing. Details are presented to the auditor(s) with long narratives to fill any gaps in documentation. All the while, the auditor(s) make assessments based on what is seen, not on what is heard. During the TMF review the auditor(s) is asking, “What does the documentation say?” and not “What does the study team tell me happened?” In that case, is it worth the study team’s time to host the TMF audit in-person, when the results are based primarily on documentation and no explanation?

Having an independent review of the documents will guarantee that the documents can stand alone, that the story can be told through the adequate filing and upkeep of essential documents. The study team can save the added stress of being audited, and the auditor can move through the documentation more quickly in order to provide findings and recommendations. At the conclusion of the audit, the sponsor will know what story the documentation tells, and whether it is the story they intended to tell or whether some work is needed to fill those gaps.

Does your documentation tell the right story about your study?  Download our checklist to make sure you’ve covered all your bases.

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