Delegation log in Pharmacy file

[ilyas ali]

Dear Forum members,
I need a clarification on holding a copy of delegation log in pharmacy file.
I have been asked by one of the CRA, do I keep a copy of delegation log in pharmacy file? I said we only keep delegation log at Investigator site file.
He explained me that we need to keep a copy in pharmacy file which should act as reference to cross check that only doctors on delegation log should be prescribed the IMP. How practical it is?
Any suggestions please..

[Buzzy bee]

Hi, we keep an electronic spreadsheet of who is on each of our delegation logs on a shared drive on our
computer system that can be accessed but not changed by everyone who has access to the drive. This
enables team members like Pharmacy and medical staff to see who is on each delegation log.

[Helen Bell]

Hi,

We keep delegation logs in the pharmacy file, but the main issue we have is if they are update for some reason, eg someone being removed due to not having curent GCP training, we are not automatically informed. We are there fore in the process of setting up a system where by we check with the Research nurse for a particular study to see if our delegation log is current.

When we write dispensing proceduers we always state to check the delegation log to ensure the prescriber is on the log, this means that when there are changes we don't have to re-write the dispensing procedure - only up date the log. We still need to be informed of any changes - which doesn't always happen.

We only found out about the above scenario when reading minutes of a meeting, but once we have the new system in place that should avoid that happening in the future.

Hope this helps.

[ilyas ali]

If we keep an electronic spreadsheet how would dispensary team know regarding prescriber. 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.

[CRA]

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.