Establishing monitoring requirements
The Sponsor will agree, risk assess, and decide on the level of monitoring required for the trial. This will include IMP management activities and will be reflected in the monitoring plan.
Sponsor Lead Pharmacist should provide input to any aspects of the IMP that need specific monitoring actions, e.g. if IMP storage is outsourced by pharmacy.
The general risk assessment for the trial and IMP risk assessment will inform the monitoring plan.
Sponsor Pharmacy representatives should attend the regular Sponsor trial management meetings, safety review committees and any other meetings on behalf of the Sponsor as required. They will have a key role in any regulatory inspections for the trial.
Supporting participating sites
Sponsor Pharmacy representatives may be expected to support participating sites in the conduct of the trial throughout, taking queries and managing IMP supply issues.
Reviewing participating site visits
Sponsor pharmacy should, where possible, be involved in the review of participating site/pharmacy monitoring visit reports to assess any IMP related issues.