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Additional considerations for single or multi-centre trials

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

Ensure the correct process is followed depending on whether it is a single or multi-centre trial sponsored by an NHS organisation.

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

Single trial locations

The Sponsor Pharmacist must be involved with the provision of the documentation related to IMP required for regulatory submission and any modifications relating to pharmaceutical aspects of the trial.

This includes, but is not limited to:

  • IB
  • IMPD and NIMPD
  • simplified IMPD (sIMPD) or simplified NIMPD
  • labels for IMP and NIMPs
  • patient-facing documentation
  • cover letters ensuring any necessary clarifications for IMP and NIMP are appropriate, etc.

Multicentre trial sites

Where the trial is to be delivered in multiple locations within the UK, there is an expectation that the Health Research Authority (HRA) Pharmacy Assurance process is undertaken.

Costs relating to HRA review may be incorporated into the funding application if deemed appropriate.

Update history

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