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Clinical trials
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Clinical trials
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Guidance
(17)
Advanced therapy medicinal products
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Clinical trials
(17)
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(2)
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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
Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries
15 November 2022
·
Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs
Assuring Investigational Medicinal Product (IMP) supply
22 September 2022
·
Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs
Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites
16 September 2022
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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
Guidance
Clinical Trials
Advice and guidance to support the provision of pharmacy clinical trials services
Costing Clinical Trials of ATIMPs using the NIHR iCT - Advice for Pharmacy Sites
12 July 2022
·
Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.
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