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Clinical trials

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Risk assessing Investigational Medicinal Products (IMPs)

12 December 2022Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs

Feasibility and setting up of clinical trials at participating sites

12 December 2022An overview of the Sponsor Pharmacy's responsibilities during setup of a clinical trial as part of participating site management

Constructing a pharmacy manual for clinical trials

12 December 2022Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials

Monitoring and auditing clinical trials by participating sites

12 December 2022An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing a clinical trial as part of participating site management

Closing clinical trials

12 December 2022Sponsor pharmacy responsibilities during trial closure and the final monitoring visit

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

2 March 2023Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.