Delegation, Training and the Pharmacy File
Part of Trial Pharmacy (PHARM) Training: Foundations for the Trial Pharmacy.
About 2 minutes. Free, in your language, no account needed.
Why this matters
Everyone who touches investigational product must be authorized to do so, and the authorization must exist before the work.
That applies to the pharmacist, to technicians, and to anyone covering a shift.
What must be in place
Delegation. Signed by the investigator, naming the tasks, dated before the first task.
Training. On the protocol, on the pharmacy manual, and on any product-specific handling. Recorded, and dated before the work.
A current CV for each delegated person.
Covering a colleague at short notice does not create authority. If the person covering is not delegated, the work is unauthorized however competent they are.
The pharmacy file
Trials usually require a pharmacy-specific file, separate from the main site file.
It typically holds the pharmacy manual, product receipt records, temperature logs, accountability logs, dispensing records, randomization documentation where applicable, destruction records, and delegation and training for pharmacy staff.
An inspector will ask for it as a unit. A file that has to be assembled from four locations is a finding before anyone reads a page of it.
The pharmacy manual is not the protocol
They are different documents and they can disagree.
If the pharmacy manual conflicts with the protocol, ask. Do not choose, and do not assume the more recent document wins.
Record the question and the answer. A resolved discrepancy is documentation; an unresolved one repeated fifty times is a systematic deviation.
In practice
A technician who has worked in the pharmacy for years is asked to prepare a study dose for the first time.
Before they do, two checks. Are they on the delegation log for this study, dated before today? Is there a training record for this protocol and this product?
Experience is not the question. Authorization is.
What this looks like when it goes wrong
A locum pharmacist covers a week of leave and dispenses study product competently throughout.
They were never delegated. Every dispensing that week is questioned, the site files deviations, and the sponsor reviews whether the affected data stands.
A signature obtained the week before would have prevented all of it.
Key takeaways
- Delegation and training must both predate the work, for every person.
- Covering a shift does not create authority.
- Keep the pharmacy file complete and in one place.
- Where the pharmacy manual and protocol conflict, ask rather than choose.