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Clinical trials

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Understanding local governance in CTIMPs

12 December 2022Sponsor pharmacy's role in ensuring appropriate local governance arrangements for CTIMPs

Understanding essential documentation for clinical trials submissions

8 December 2022Sponsor responsibilities for writing and maintaining essential documents required for Clinical Trial Authorisation applications

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

Supporting funding applications for CTIMPs

12 December 2022Sponsor pharmacy role in funding applications and establishing costs for sponsor activities

Risk assessing Investigational Medicinal Products (IMPs)

12 December 2022Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

2 March 2023Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.

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

Outsourcing ATIMP Handling: A Template Technical Agreement

7 February 2024A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites

Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites

16 September 2022A 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

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
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