Service advice
The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
Identifying key areas where pharmaceutical expertise is required by sponsors for conducting non-commercial clinical trials
Understanding local governance in CTIMPs
Sponsor pharmacy's role in ensuring appropriate local governance arrangements for CTIMPs
Supporting funding applications for CTIMPs
Sponsor pharmacy role in funding applications and establishing costs for sponsor activities
Understanding essential documentation for clinical trials submissions
Sponsor responsibilities for writing and maintaining essential documents required for Clinical Trial Authorisation applications
Risk assessing Investigational Medicinal Products (IMPs)
Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs
Additional considerations for single or multi-centre trials
Ensure the correct process is followed depending on whether it is a single or multi-centre trial sponsored by an NHS organisation
Assuring Investigational Medicinal Product (IMP) supply
Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs
Constructing a pharmacy manual for clinical trials
Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials
Feasibility and setting up of clinical trials at participating sites
An overview of the Sponsor Pharmacy's responsibilities during setup of a clinical trial as part of participating site management
Monitoring and auditing clinical trials by participating sites
An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing a clinical trial as part of participating site management
Closing clinical trials
Sponsor pharmacy responsibilities during trial closure and the final monitoring visit
Planning
Costing Clinical Trials of ATIMPs using the NIHR iCT - Advice for Pharmacy Sites
Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.
Supply
Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries
Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs
Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites
A summary of the implications of the UKs exit from the EU for clinical trial sites for both IMP and ATIMPs, including supply to and from Northern Ireland