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Monitoring and auditing clinical trials by participating sites
12 December 2022
·
An 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 2022
·
Sponsor 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 2022
·
An 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 2022
·
Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs
Supporting funding applications for CTIMPs
12 December 2022
·
Sponsor pharmacy role in funding applications and establishing costs for sponsor activities
Understanding local governance in CTIMPs
12 December 2022
·
Sponsor 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 2022
·
Identifying 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 2022
·
Ensure 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 2022
·
Sponsor responsibilities for writing and maintaining essential documents required for Clinical Trial Authorisation applications
Using solid oral dosage form antibiotics in children
7 December 2022
·
Crushing or dispersing whole solid dosage forms or opening capsules is an "off-label" use. This includes use for Group A streptococcal infections.
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