Trial documentation

Trial documentation

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

Back to all clinical trials sub-sections
pdf
27/02/2023

ABPI Roadmap

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring.
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Online Article
27/02/2023

Clinical trials for medicines: apply for authorisation in the UK

Government advice on how to apply for a clinical trial including eligibility phases model IMPDs costs and how to make changes to your application.
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Online Article
27/02/2023

HRA – a guide to managing projects via combined review

For new for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined IMP/device trials. A step by step guide on how use use IRAS for a combined review.
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Online Article
27/02/2023

HRA – Preparing Study Documentation

When applying for HRA Approval you will need to check what supporting documents you will need to provide well in advance of when you expect to submit your application. This will avoid unnecessary delays to your application. This page details the required supporting documentation.
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Online Article
27/02/2023

HRA Consent and patient information guidance and templates

The Health Research Authority's (HRA) online guidance to share best practice on consent and participant information by providing examples and templates.
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Online Article
27/02/2023

HRA Consent and patient information guidance and templates – Researchers and Ethics Committees

The Health Research Authority's online guidance for researchers and ethics committees on consent and how to prepare materials to support this process.
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Online Article
01/07/2020

In Vivo (virus based) gene therapy medicinal products – pharmacy institutional readiness guidance

The purpose of document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.
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Online Article
27/02/2023

Integrated Research Application System (IRAS) – preparing and submitting applications

Advice on preparing and submitting applications on Integrated Research Application System (IRAS).
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Online Article
27/02/2023

NIHR Clinical Trial Routemap

The NIHR Clinical Trial Routemap is an interactive colour-coded tool to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices along with more detailed information available at ‘stations’ along the route.
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  • Governance

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

    Read more about this section.

    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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