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Compliance In Focus
Posted by John Lehmann on Fri, Jun 8, 2012

Clinical Research: The To-Do List Goes On and On….

Action ItemsEveryone has a “To-Do” List or lists; Things to do at work, at home, during the week, on the weekends, sometimes even on vacations.  To-do lists pile up and add up.  Just when you think that your list may be shortening, more to-do’s get added on or new lists are started.

The research environment is not without its own to-do lists. Coordinators have to-do lists pertaining to their subjects, their investigators and their sponsors. To-do lists from sponsors are often referred to as action items. Action items are often tasks that are identified either during monitoring visits or in between monitoring visits that cannot be immediately addressed and resolved. In order to keep monitors, coordinators, principal investigators, study managers and other study staff organized, action item lists may be created and documented in monitoring reports, in a study database, or in some cases they have their own software to track them!

Monitors and site study staff work together to address and follow up on action items. To name a few, action items can be noted for subject care related activities such as:

  • Missing or unavailable source documents
  • Medical history inconsistencies and prior or current treatments

Action items can also be noted for regulatory items such as:

  • Incomplete IRB communication
  • Training and delegation of authority logs
  • Updated lab certifications

… The list goes on and on…

Most times, when an action item is identified, it is given an anticipated resolution date.  Just as the examples of action items can go on and on, so can these resolution dates. Ideally, action items are identified and resolved prior to or during the next monitoring visit. This, of course, is just in time for the next list of action items to begin. However, some action items carry over several monitor visits, despite the best efforts to close them.  Action items that go unresolved may increase the risk to the subject(s), and leave the site and the sponsor at risk for being out of compliance of the regulations, protocol, IRB policies or study agreements. Even still, unresolved action items oftentimes do not result in consequences to the site, aside from the monitor continuously nagging to get them done.

Do you think that sponsors should include consequences to the principal investigator for ongoing unresolved action items? What would be a fair and reasonable consequence? Should the sponsor take the action item’s seriousness or significance into consideration when determining possible consequences?  Please share your experiences with us!

Photo Credit: koalazymonkey

Topics: Coordinators, To-Do List, Clinical Research


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