Quote Originally Posted by ilyas ali View Post
Even I have seen commercial sponsors are happy if we don't keep delegation log in the pharmacy file but some non-commercial sponsor said it must be kept in pharmacy file.
If a copy of the delegation log is not kept in pharmacy how do the pharmacy procedures show that it has been appropriately prescribed? In my experience this is often done by a check in pharmacy against the delegation log however there are other ways of doing this. I have seen situations where the check is done by the Research Nurse in the clinic and the prescription counter-signed for this purpose. The pharmacy process is to check for this counter-signature. I don't think it is a requirement that a copy of the delegation log is kept in pharmacy if you can demonstrate that there is a process to ensure appropriate prescribing by those that are delegated to do this. If you have a robust process in place you should discuss this with your CRA/Sponsor as an alternative. I would be interested to know what your process is if you do not keep a copy of the log in pharmacy.