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.

Government advice on how to apply for a clinical trial including eligibility phases model IMPDs costs and how to make changes to your application.

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.

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.

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

The Health Research Authority's online guidance for researchers and ethics committees on consent and how to prepare materials to support this process.

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.

Advice on preparing and submitting applications on Integrated Research Application System (IRAS).

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.