THE IMPLEMENTATION CHECKLIST

 


The benefits of switching to a purpose built eTMF (electronic Trial Master File) are now well established:

  • gaining better insights into TMF completeness,
  • quality and timeliness
  • reducing time spent on manual tasks (for examples, document tracking, or assigning and performing QC)
  • simplified document sharing and processing
  • role based access for secure document sharing
  • and much more

It all adds up to a more efficient and high quality TMF. However, these benefits will not magically appear once the decision to switch to an eTMF is made – there are still a number of roadblocks ahead.

Download our eTMF Implementation Checklist and get a head start.


 

SOME QUESTIONS  THIS CHECKLIST WILL HELP ANSWER


 

 


The following are just some of the questions you may be faced with when making the switch to an eTMF. The key to answering them (and more) is by having a solid eTMF implementation plan. This will ease the transition and give yourself the best chance of success.

TMF CONTENT: The new system uses the TMF Reference Model to categorize documents – how do I switch over to a new filing structure? It can also collect and display far more information (or metadata) about my documents than before – how am I going to make use of this? How will my TMF staff adapt to these changes?

TMF QUALITY: How will my QC process be affected by this change? Are my SOPs, work instructions, etc still relevant? What about our file naming and document identification standards? How do we ensure a high quality archive at study close? And again, how can my TMF team get acclimated to these changes?

TMF OVERSIGHT: Our plans for all of the above won’t matter if we can’t clearly define the right roles to do it, or then track and measure our success. Who will be responsible for doing what in the new system? What training do they need? What metrics do we want to track (e.g. for TMF completeness, quality, timeliness), and is this info readily available in the eTMF itself?


Download our eTMF Implementation Checklist and get a head start.