Clinical trials
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Pharmacy Manual Checklist for Clinical Trials for ATIMPs
2 March 2023Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.
Closing clinical trials
12 December 2022Sponsor pharmacy responsibilities during trial closure and the final monitoring visit
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
Constructing a pharmacy manual for clinical trials
12 December 2022Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials
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
Risk assessing Investigational Medicinal Products (IMPs)
12 December 2022Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs
Understanding local governance in CTIMPs
12 December 2022Sponsor pharmacy's role in ensuring appropriate local governance arrangements for CTIMPs
Additional considerations for single or multi-centre trials
8 December 2022Ensure the correct process is followed depending on whether it is a single or multi-centre trial sponsored by an NHS organisation
Understanding essential documentation for clinical trials submissions
8 December 2022Sponsor responsibilities for writing and maintaining essential documents required for Clinical Trial Authorisation applications
Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries
15 November 2022Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs