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Closing clinical trials

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Topics: Clinical trialsRegulatory

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 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

Document retention

The Sponsor Lead Pharmacist will be required to keep all correspondence and documentation related to the trial for a specific section of the Trial Master File for regulatory purposes.

This section will be collated to the overall Trial Master File at the end of the trial, according to the Sponsor processes.

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 perform a final monitoring visit to ensure the site trial folder is complete, and all deviations closed.  Once complete the site may archive their folder in line with the relevant document retention requirements.