Preparation is key to pass your Good Clinical Practice (GCP) inspection. You need to prepare well in advance and certainly not shortly before.
Do you remember your school teacher telling you not to wait until the last minute to study for your final exams? Analogously, if you attempt to make your organization compliant and ready for GCP inspections at the last minute, you may utterly fail. Instead, the management of your clinical Trial Master File (TMF) should be an everyday task.
As described by the European Commission, a TMF consists of essential documents to conduct a clinical trial (Directive 2005/28/EC Article 16). It may be subject to regulatory inspection to ensure the compliance of the trial with GCP guidelines; therefore, documents may need to be immediately produced upon request.
Distributed passive TMFs are made of multiple document repositories, where files are uploaded only after they are finalized. If you have passive TMFs, it may be challenging to quickly prepare and compile all documents for inspection. And with the increasing number of trials and stakeholders involved — either internal or external, either sponsor or contract research organizations (CROs) — it can become very difficult to guarantee instant document availability and accessibility.
These factors alone force most organizations involved in clinical trials to adopt a central active TMF with e-documents. An electronic TMF (eTMF) facilitates collaboration and safe data sharing. It also provides visual signals for inspection readiness and allows for real-time adjustments. But it can create potential complications. Electronic TMFs spur the need for organizational change and bring new kinds of challenges, many of which are initially unforeseen. One solution is to setup internal processes for accurate clinical trial planning, submission, and approval via automated workflows. That means end-users must adopt new business processes, which may entail change management.
At this point, it may seem like managing your eTMF is impossible. But again, the only way to succeed is to start preparing today. Implement a viable eTMF solution that is geared toward future pivots and needs, beyond merely fulfilling TMF requirements. That will result in operational improvements that are sustainable and foster more transparency, as well as improved communication among all stakeholders and a shared knowledge of business processes and ownership. You will also avoid the risk of falling into the trap of compliance becoming the end goal.
Also, keep in mind that the European Medicines Agency (EMA) is in the process of implementing ISO standards for the Identification of Medicinal Products (IDMP) and that you will soon need to be compliant. Fortunately, many of the data elements required by IDMP can be found in the eTMF. By ensuring complete operational efficiency of your eTMF solution, you will take a giant stride forward for IDMP implementation.
Overall, improving your TMF or eTMF tool as soon as possible will boost your company’s performance and prepare the groundwork for IDMP implementation. Want to learn more about evaluating your TMF performance? Read our article here. Want to better manage your clinical TMF? Please contact Mathilde Chevallier.