For multicentre trials the Sponsor Lead Pharmacist should review the feasibility form and associated guidance sent to the host pharmacies.
Contact with participating sites may be by the Sponsor pharmacy team or may be by the Sponsor project management team, depending on different organisations.
During initiation of a site, the Sponsor will request the following documents from a participating pharmacy site. The Sponsor Lead Pharmacist (or other Sponsor delegated team) must review the following SOPs from the local site pharmacies where applicable:
- temperature monitoring system, out of hours procedures for temperature deviations, annual calibration certificates
- blinding and unblinding procedures, out of hours procedures when applicable
- recall Standard Operational Procedure (SOP)
- destruction SOP or waste policy for the site
When required, depending on risk assessment:
- dispensing / checking procedures, including prescriptions, accountability logs, etc.
Errors or omissions
When there are inadequacies at a participating site identified by the Sponsor that might put the safety of the participants or the validity of the research at risk, an action plan must be put in place. This must be completed by the host site prior to giving Sponsor green light to the site. Sponsor lead pharmacist should advise on the mitigations required in these instances where appropriate.