Delegate or die! (okay, maybe not)

In a perfect world the principal investigator would perform all his own research, enter his own data, and record all adverse events that occur in a trial. News Flash! That doesn't really happen!

The FDA does realize that the PI cannot do everything so it allows for delegation of certain tasks to individuals who have been trained to do that task and are qualified to do so. Unfortunately there is not too much out there to guide investigators as to what extent this delegation can occur. Consequently, what could be seen as improper delegation in eyes of one individual could be seen as completely acceptable to another, and neither could matter if an FDA inspector feels differently! There are certain guidelines that the FDA mentions such as who can perform physical exams (unless stated otherwise by a sponsor, it would go by what qualifications are acceptable from state to state), but generally delegation of tasks is left to up to the PI.

In many situations, the coordinator will complete the delegation log and the PI will sign off on each individual participating in the trial as proof that he is indeed passing on/sharing responsibility with him or her. That being said, here's a few reminders to help avoid problems with the delegation log (as well as a potential 483) in the event of an audit:

-Make sure you have clarification from the sponsor, in writing as always, as to who exactly can perform the following: physical exams, ECG assessments, Lab assessments, AE assessments, special study evaluations like neurological exams. Improper delegation of these tasks can be a huge headache if it has to be resolved after participants have already entered a trial (I'd be happy to elaborate...just let me know if you want more of this!)

-The PI really should be the only one who signs off on the Case Report Forms (CRFs) as accurate representations of data collected during a trial. Sub-investigators do not sign the back of the 1572 and should not be delegated the responsibility of signing CRFs.

-Specialized tasks require people with specialized training. Is there a certain type of diagnostic assessment like an echocardiogram or a sleep study? If so, the person running those assessments should have documentation of appropriate training and should definitely sign the delegation log.

-Make sure that everyone who has not received sponsor provided training on the trial (ie: didn't attend the site initiation visit) has documentation of training in place before the delegation log is completed. This training should note the training involved, who was providing it, who received it, and most importantly, that the PI verified it. Just like improper the improper delegation described above, delegation of tasks without training is another huge headache that is very easily avoided with due diligence.

In the interest of suspense and writer's cramp, that is part I of delegation log tips....more to follow soon!