Clinical Trials

Clinical Trials

This section has a range of resources – split into 8 sub-sections – to assist industry sponsors and partners in understanding the process for preparing for the delivery of advanced therapy clinical trials. Its objective is to share best practices regarding governance, infrastructure, and processes that underpin successful trial execution.

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  • Trial governance

    Trial governance

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    Information regarding the governance arrangements to approve, set up and manage clinical trials of advanced therapy investigational products is included here, with details on local governance, committees, feasibility and risk assessments.

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  • Trial planning and design

    Trial planning and design

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    Resources in this category include information around risk assessment, protocol development, and feasibility.

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  • Trial management and monitoring

    Trial management and monitoring

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    Resources in this category include information around trial supplies, and pharmacovigilance.

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  • Trial documentation

    Trial documentation

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    Resources in this category include information around eCRFs/CRFs, protocol, and pharmacy manuals.

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  • Contracts and agreements

    Contracts and agreements

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    Resources in this category include information around quality technical agreements and model study agreements.

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  • Reporting

    Reporting

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    Resources in this category include information around safety reports, progress reports, and serious breaches.

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  • Logistics

    Logistics

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    Resources in this category include information around shipping and ordering, chain of custody, receipt and storage, dispensing, preparation, administration, returns and disposal.

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  • Trial closure

    Trial closure

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    Resources in this category include information around early termination, end of trial declaration, dissemination of results, and archiving.

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