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Is your TMF inspection ready?

​Authority requirements

Efficient clinical trials are key factors in reaching the market  first. And with the EU clinical trials directive transforming into a clinical trials regulation, the requirements for the trial master file (TMF) are increasing. One of the changes the clinical trials regulation entails is the need to ensure that the TMF is readily available and accessible at all times, but how do companies ensure that their TMF will be in compliance? 

The impact of the regulation

Many companies have a hybrid TMF for both paper and electronic files. This is a challenge during authority inspections and, in particular, on multinational trials. But is the solution to have an eTMF? 
A TMF or an eTMF consists of input from many different stakeholders and is most likely to affect a series of IT systems. To identify the location of the documentation and create an overview, information must be collected from every business unit involved in the TMF/eTMF.  

How NNIT can help you

NNIT can help you become compliant and enhance your inspection readiness. The first step is to make a gap analysis. NNIT’s gap analysis consists of several parts: 

  • Mapping the current TMF documentation: We interview the relevant parties of the organization and perform a SOP review to identify where the documentation is located and how it can be accessed. 
  • Aligning with the TMF reference model: We map the TMF content against the TMF reference model and link your TMF content to the reference model’s artifacts. 
  • TMF inspection strategy: The outcome of the mapping is handed over to you in a report that will enable management to create a strategy for the TMF and for inspection readiness.  

The TMF Reference Model 

Version 3.0 of the TMF reference model has been available since June 2015. If your company is following v2.0, this will entail remapping of your TMF structure against the updates in v3.0. We encourage you to investigate the changes and to consider how they impact your TMF.  
NNIT is also involved in the TMF reference model working group, Inspection readiness and consultant Dorte Frejwald has personal experience with inspection preparations. 







NNIT here+45 7024 ​ ​​​​​​​​​​​​ here



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