Service advice and planning
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Assurance of aseptic preparation of medicines
21 March 2023Updated guidance from NHSE to reflect governance and visibility of the assurance and audit of unlicensed aseptic preparation
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
Assuring Investigational Medicinal Product (IMP) supply
22 September 2022Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs