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Monitoring and auditing clinical trials by participating sites

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Topics: Clinical trialsService advice and planning

An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing a clinical trial as part of participating site management

This article forms part of a series
  1. The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
    1. Understanding local governance in CTIMPs
    2. Supporting funding applications for CTIMPs
    3. Understanding essential documentation for clinical trials submissions
    4. Risk assessing Investigational Medicinal Products (IMPs)
    5. Additional considerations for single or multi-centre trials
    6. Assuring Investigational Medicinal Product (IMP) supply
    7. Constructing a pharmacy manual for clinical trials
    8. Feasibility and setting up of clinical trials at participating sites
    9. Monitoring and auditing clinical trials by participating sites
    10. Closing clinical trials

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.

Sharing information

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.