What does eTMF Collaboration mean to You?

September 19, 2014

  • eTMF Resources

Often, in proposals, presentations, and client discussions, we are asked if our eTMF supports “collaboration.”  This is not a new question – collaboration has been a desirable feature of EDMS/eTMF systems for many years.  Over the years, I’ve become wary of giving the easy answer – “Yes” – and have been more inclined to answer with “First, tell me what collaboration means to you.”

The range of answers is startling.  For some, collaboration simply means the ability for a group of users (perhaps from different organizations) to share a workspace that provides insight into a shared set of documents.  For others, it means to collaborate on a workflow task – perhaps a simultaneous document review.  Collaboration might also mean the ability to work together on a task that spans document, such as IP Green Light/Drug Shipment or study closeout.  For those focusing on collaborative authoring, collaboration might mean the ability to simultaneously author a document using sophisticated capabilities such as those offered by our friends at PleaseTech in their PleaseReview product.  For the truly ambitious, it might mean all of the above.

All of these answers are valid, but a person answering in one context could worst case be viewed as untruthful by someone who meant something entirely different when asking about collaboration!  It’s best that both those asking the questions and those answering be as specific as possible.

When talking about collaboration in the eTMF world, it’s best to start with some basic scope decisions:

  • Who do you envision accessing the eTMF?  Sponsors, CROs, sites, co-development partners?  Will colleagues in groups such as regulatory and legal require direct access?
  • What sort of tasks will require collaboration and how would you expect the parties to work together?
  • Do you expect collaboration to be needed in document authoring, and if so, will it be extensive?  Few organizations author large documents such as protocols, IBs and study reports in their eTMFs, and if you are mostly authoring small documents, the extra complexity associated with collaborative authoring may not be justified.
  • How do you envision review and approval (or other) workflow processes to work?
  • How important is knowledge sharing within eTMF?  Do you expect eTMF to provide some sort of knowledge base or will that be external?

Understanding collaboration needs will assist sponsors and CROs in asking the right questions, and vendors and consultants in providing accurate and specific answers.