Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials

Site pharmacy manuals

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

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

Pharmacy Manual Contents

Key components of a pharmacy manual include:

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

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