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Study Management & Closure: Amendments

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Introduction

In light of emerging data and ongoing risk assessment, it may be necessary to make changes to the protocol or to other study documentation (e.g. patient information sheets).  It is good practice to use a version numbering system on all study documentation, so that you and your research team are able to ensure that you are working from the correct documents.  Any amendment must be effectively communicated to the research team and collaborators, including the date of implementation.

Research ethics committee: If such changes are substantial (see HRA Amendments resource below for help in identifying substantial amendments), you should submit a completed Notice of Amendment form, which can be generated from IRAS.  This will be submitted to the main REC, together with any changes to be made to study documentation.  Details of non-substantial amendments need only be notified for information.  If you are not sure if your amendment is substantial, contact the main REC for advice.

HRA Approval review of amendments:  From 31 March 2016, studies led from England involving the NHS are expected to notify the HRA of both substantial and/or non-substantial amendments using the Notice of Amendment form.  This process replaces the need to inform NHS R&D offices in England of these amendments.

NHS R&D review of amendments:  For studies led from Northern Ireland, Scotland or Wales involving the NHS/HSC, all amendments should be notified to NHS/HSC R&D.  This applies both to substantial and non-substantial amendments.

Gene Therapy, xenotransplantation or stem cell therapy trials:  Responsibility for ethical approval and subsequent amendment of these trials has transferred to the Health Research Authority (HRA).

University Research Offices / Sponsor: Similarly you should notify University Research Offices and your study sponsor of any amendments.  Any external audit of your study will monitor adherence to the most recently approved protocol.

Funder: If amendments are likely to impact significantly on your funding arrangements, you should also notify the relevant funding body.

Clinical Trials of Investigational Medicinal Products: Be aware that if you are conducting a clinical trial of an investigational medicinal product your sponsor (probably through the Chief Investigator) is required to submit a notice of amendment to both the ethics committee and the MHRA.

Medical Devices: The MHRA must approve of all amendments to the device, the clinical investigation plan, Investigators or participating institutions.

Resources

  • 1. HRA Amendments

    Information on substantial and non-substantial amendments, how to prepare amendments and which review bodies need to approve these or be notified.

    Good Practice for all research Date added: 29 October 2008
  • 2. NIHR Clinical Trials Toolkit: Amendments

    NIHR Clinical Trials Toolkit guidance on substantial amendments for clinical trials conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations.

    Legal Requirement for some em studies (not applicable for all) Date added: 6 November 2008
  • 3. IRAS (Integrated Research Application System)

    The Integrated Research Application System (IRAS) is a single system for applying for approvals for health and social/community care research in the UK.

    Standard Process for all research Date added: 29 October 2008
  • 4. IRAS: guidance on minimal datasets

    IRAS guidance on 'minimal datasets' for creating and managing amendments from September 2009

    Standard Process for some em studies (not applicable for all) Date added: 28 September 2009