Advice and guidance to support the provision of pharmacy clinical trials services.

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


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.


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