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Clinical trials
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Clinical trials
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Guidance
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Guidance
Clinical Trials
Advice and guidance to support the provision of pharmacy clinical trials services.
Risk assessing Investigational Medicinal Products (IMPs)
12 December 2022
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Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs
Understanding essential documentation for clinical trials submissions
8 December 2022
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Sponsor responsibilities for writing and maintaining essential documents required for Clinical Trial Authorisation applications
Understanding local governance in CTIMPs
12 December 2022
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Sponsor pharmacy's role in ensuring appropriate local governance arrangements for CTIMPs
Constructing a pharmacy manual for clinical trials
12 December 2022
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Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials
Additional considerations for single or multi-centre trials
8 December 2022
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Ensure the correct process is followed depending on whether it is a single or multi-centre trial sponsored by an NHS organisation
Outsourcing ATIMP Handling: A Template Technical Agreement
7 February 2024
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A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites
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