I believe delegation logs have gotten out of hand in many ways. Yes, there is a purpose for them and we have had our own delegation log for over 20 years. Over the years the delegation log has evolved into a land mine. Each sponsor does it their own way and some go so far as to delegate every potential task, which is both unnecessarily cumbersome and redundant.
The delegation log should not be a form that causes problems in an audit, but often turns into one of the major issues in an audit. This arises from the complexity of deciphering all of the changes and corrections requested by the CRA / sponsor, along with dates and initials in (generally) very limited space, leaving it so that many times you or an auditor cannot figure out what is happening. This form should include main protocol tasks only: who is acting as a sub investigator, who is completing CRC tasks and who is completing administrative tasks?
If sponsors continue to expect myriad tasks to be delegated, this form needs to have more space allotted for each individual, and should be in a form that is readable, more user friendly, and does not change mid-study. The PI should sign each page once when delegating tasks again if there are any changes and, finally, at the end of the study. It is not practical to have the PI sign every line on every page. PIs know to whom they delegated tasks, and signing once shows that they have reviewed the page just as much as signing each line does. The delegation form is a useful and necessary form, but it should not become busy work for the sponsor, CRA, CRC or the PI, and should not leave a site unnecessarily exposed to audit findings.
This is a comment written by Janet Lewis, RN, CCRP with additions by Brooke Barrick, CCRP on a LinkedIn discussion of delegation logs in 2014
