The Log With Your Name On It
Part of Sub-Investigator (SUBI) Training: What a Sub-Investigator Is.
About 2 minutes. Free, in your language, no account needed.
The delegation log is the document that authorizes you
It names you, lists the specific duties you may perform, gives a start date, and carries the principal investigator's signature.
Without it, work you do is work an unauthorized person did, however well you did it.
Read your own entry before you start
This takes thirty seconds and it is the check most often skipped.
Are you on the log? Is the start date before today? Do the listed duties actually cover what you are about to do?
Duties are specific
Being delegated to perform physical examinations does not authorize you to take informed consent. Being delegated to assess adverse events does not authorize you to make eligibility determinations.
Studies differ in how they divide these. Do not assume this study delegates the same set as the last one.
Dates are where it fails
The most common finding is not an absent delegation. It is a delegation dated after the work.
If you assessed a participant on the 3rd and the log shows you starting on the 10th, the record says an unauthorized person made a medical judgment in a clinical trial.
That is true regardless of your qualifications, and it cannot be corrected retrospectively.
Your qualifications sit alongside it
A current CV, your medical registration, and documented GCP and protocol training.
These evidence that you were qualified at the time. A CV updated two years after you joined does not demonstrate what you knew when you started.
Ending is documented too
When you stop working on the study, the log records an end date. Work after that date is outside the delegation just as surely as work before the start date.
When you are asked to cover
Tell them you are not delegated, if you are not. The PI can usually add and date it the same day.
Doing it first and correcting the log afterward is how a straightforward gap becomes a finding about the site's integrity.