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Clinical trials

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Outsourcing ATIMP Handling: A Template Technical Agreement

7 February 2024

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

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

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

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