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Monitoring and auditing clinical trials

Published Last updated See all updates
Topics: Clinical trialsService advice and planning

An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing clinical trial locations.

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 the supply chain for IMPs and NIMPs
    7. Constructing a pharmacy manual for clinical trials
    8. Feasibility and setting up of clinical trials at delivery locations
    9. Monitoring and auditing clinical trials
    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 and NIMP management activities and will be reflected in the monitoring plan.

Sponsor Pharmacist should provide input to any aspects of the medicinal products that need specific monitoring actions, e.g. if IMP storage is outsourced (SPS page) by pharmacy.

The general risk assessment for the trial and IMP risk assessment and any NIMP considerations 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 locations

Sponsor Pharmacy representatives may be expected to support participating locations in the conduct of the trial throughout, taking queries and managing IMP and NIMP supply issues.

Reviewing participating location visits

Sponsor pharmacy should representatives, where possible, be involved in the review of participating location/pharmacy monitoring visit reports to assess any IMP and NIMP related issues.

Update history

  1. Updated in line with amendments to clinical trials regulations. Title amended.
  1. Published