Signature Practices and Technologies for TMF Survey Results

November 21, 2014

  • eTMF Resources

A few months back, I conducted a series of interviews on TMF signature and paper document retention practices.  I was fortunate to be able to speak with a number of experienced and knowledgeable colleagues at pharma companies and CROs large and small, who were very candid about their challenges and achievements.

I then solicited additional input from a wider group with a survey.  The results were eye-opening: there is really no consensus in the industry about what documents require signatures, what hard copy originals have to be retained, and who has to retain them (this sponsor, the CRO, or the site).

Signature Practices and Technologies for TMF

The details of the interviews and surveys were presented at DIA EDM in Washington DC in September and the ExL Pharm TMF Summit in London in October.  You can view the presentation for all of the details, so I’ll only include the summary in this post:

 

Make sure that everything that can be electronic is electronic

  • It’s quite common that documents that originate electronically get printed and scanned

Sign fewer documents!

  • Examine what you are signing and why

  • Reduce number of signers, especially “FYI” signers

  • More achievable in eTMF than paper

Replace wet ink with eSignature

  • Many challenges, especially for outside parties

Collect less paper

no paper

  • Again, review what you are collecting and why

  • Consider leaving signed paper at the site unless there is a regulation requiring the sponsor to retain

Keep filing system for paper originals simple since it’s unlikely they will need to be retrieved

  • Often just chronological

Have questions on the research?  Feel free to contact me.