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Closing clinical trials

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Topics: Clinical trialsService advice and planning

Sponsor pharmacy responsibilities during trial closure and the final monitoring visit

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

Document retention

The Sponsor will be required to keep all correspondence and documentation related to the trial for regulatory purposes in the Trial Masterfile. This includes any information and documents related to IMP and NIMP management.

Archiving documentation

Archiving of the Trial Master File must be done in accordance with regulation and local procedures.

Final monitoring visit

As part of trial close down, Sponsor monitoring staff should conduct a final monitoring visit to ensure the location trial folder is complete, and all deviations closed. This can be done remotely when stipulated by the monitoring plan. Once complete the delivery organisation may archive their folder in line with relevant regulatory requirements, GCP and their local SOPs.

Update history

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