Study Management & Closure: Amendments
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 NRES SOPs below for help in identifying substantial amendments), you should submit a completed Notice of Substantial 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.
If your study was approved from an NRES on-line form i.e. not generated on IRAS, you should create a 'minimal dataset' on IRAS. This facility will provide sufficient data to enable SSI Forms, amendment forms and ARSAC forms to be created. The NRES on-line form is now only available in a read-only capacity; no new forms can be generated using this method. Please see the guidance on the IRAS website for more details (see resources below).
Gene Therapy, xenotransplantation or stem cell therapy trials: Responsibility for ethical approval of these trials has been transferred from the Gene Therapy Advisory Committee (GTAC) to the National Research Ethics Service (NRES), which forms the core function of the Health Research Authority (HRA). Further information on these new arrangements can be found on the Ethical Approval page on this Tool Kit. Details on how to submit amendments can be found on the HRA website.
Research and Development / Sponsor: Similarly you should notify NHS and/or University Research and Development 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.
HRA flowchart detailing the procedure for notifying ethics committees and MHRA of a substantial amendment to a clinical trial of an investigational medicinal product.Legal Requirement for some em studies (not applicable for all) Date added: 23 October 2008
HRA flowchart detailing the procedure for notifying ethics committees of a substantial amendment for all other research studies.Good Practice for some em studies (not applicable for all) Date added: 23 October 2008
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
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
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
IRAS guidance on 'minimal datasets' for creating and managing amendments from September 2009Standard Process for some em studies (not applicable for all) Date added: 28 September 2009