Delegate or Die Part II

So let's get back to the delegation log discussion. Here are a few more tips on avoiding delegation log issues:

-Every investigator on the 1572 should sign the delegation log, even if an investigator does not perform any trial related activities. Once again, make sure that investigators are appropriately trained and have corresponding training documentation...an untrained investigator evaluating study participants is almost as bad as having an investigator not on the 1572 seeing them.

-Make every effort to have investigators print their own name, sign their own name, and sign their own initials on the delegation log. One purpose of the document is to prove the authenticity of signatures/initials on study documents, this cannot be accomplished by someone else signing the name of an individual on the delegation log.

-If your site uses dedicated recruiters, don't forget to have them sign the log as well. Recruitment is a part of the study enrollment process, so anyone assisting with it should be included on the delegation log

-Keep the log up to date with end dates of study staff. It's difficult to remember when someone started/stopped a study long after the fact, keeping up with it as it occurs is best practice. In addition no one should want to look forward to having to explain why someone had a start date on the delegation log listed after he or she had already performed study assessments. Likewise for ending participation a trial before the last assessment was completed.

Finally, don't be alarmed when the sponsor keeps the original delegation log at the end of the trial....it's supposed to be that way! There are other nuances with this fine document, but if you stick to these rules you'll have fewer items to correct and fewer notes to file to write explaining discrepancies. Enjoy!