Were you there?

How many studies provide the study coordinator with proof of investigator meeting attendance?  With my experience, that number is pretty small even though the investigator meeting often serves as the site initiation visit.  If that is the case, and the sponsor does not provide a list of investigator meeting attendees, then technically there is no documentation of sponsor provided training prior to conduct of the study.  So what's the big deal?

Well, the FDA recently released revised guidance documents for investigator oversight of a clinical trial.  The documents basically re-affirm that the investigator is ultimately responsible for conduct of a study at his/her site, but I (and the FDA as well, in my opinion) believe that an investigator cannot properly oversee a study without initial guidance from the sponsor.  Usually this guidance comes from the investigator meeting or an on-site SIV, but unlike the SIV a list of attendees is not usually provided to the site following an investigator meeting.  This could very easily be a significant finding in the event of an audit, especially with the FDA's emphasis on proper oversight of a trial at a site.  Just like with everything else in research, if it isn't documented, then it didn't happen.

So what can study coordinators do to make sure this initial training documentation is in place?  Here are some suggestions:

-Ask the sponsor (project manager, monitor, whoever) for a copy of the investigator meeting attendance roster.  They have to keep it for their purposes in the event of an audit, so they should have it.

-Keep all pre-study documentation of investigator meeting documentation such as travel itineraries, meeting agendas, and contact with your CRA/project manager.  The meeting agenda is equally important in proving that site was adequately trained on appropriate trial issues.

-Hold on to any investigator meeting documentation received at the meeting.  A good example of this is a binder with powerpoint slides from presentations that is almost universal at meetings.

All three of the above suggestions can go a long way in making sure that the research site has the necessary documentation of sponsor provided training before the study starts.  It would be a travesty for an investigator to get dinged during an audit because the sponsor neglected to provide this information to a site.