Clinical trials
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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
Supporting funding applications for CTIMPs
12 December 2022Sponsor pharmacy role in funding applications and establishing costs for sponsor activities
Understanding local governance in CTIMPs
12 December 2022Sponsor pharmacy's role in ensuring appropriate local governance arrangements for CTIMPs
The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
12 December 2022Identifying key areas where pharmaceutical expertise is required by sponsors for conducting non-commercial clinical trials
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
Assuring Investigational Medicinal Product (IMP) supply
22 September 2022Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs