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Constructing a pharmacy manual for clinical trials

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

Sponsor pharmacy should construct a pharmacy manual when required by the sponsor to facilitate IMP and NIMP management by the different delivery location sites.

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

Pharmacy manuals

Pharmacy manuals are useful to ensure consistency on IMP management across the delivery organisations for multicentre trials. For single centre trials, pharmacy manuals may or may not be written at the Sponsor Pharmacist’s discretion.

The Sponsor Pharmacist should design, create or review the pharmacy manual (dependent on delegated responsibilities). The IMP and NIMP management and governance information contained must be in line with the protocol, reference safety information, GMP; GCP and current legislation.

Pharmacy manual contents

Key components of a pharmacy manual include:

  • IMP and NIMP information
  • Supply and resupply processes
  • Storage
  • Access to any electronic systems for managing the IMP and NIMP when required
  • Randomisation
  • Blinding and unblinding procedure when relevant
  • Prescribing instructions
  • Labelling and dispensing instructions of both IMP and NIMPs.
  • Administration and precautions
  • Management of temperature excursions
  • Accountability
  • IMP complaints
  • IMP disposal and destruction
  • Drug recall
  • Reimbursement arrangements for any IMP or non-IMPs
  • Monitoring
  • Archiving

Update history

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