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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

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

Using solid oral dosage form antibiotics in children

7 December 2022Crushing or dispersing whole solid dosage forms or opening capsules is an "off-label" use. This includes use for Group A streptococcal infections.