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Examples of substantial and non-substantial amendments

Last updated on 24 May 2018

Examples of substantial amendments:

  • changes to the design or methodology of the study, or to background information likely to have a significant impact on its  its scientific value;
  • changes to the procedures undertaken by participants;
  • changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study;
  • significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers;
  • a change of sponsor(s) or sponsor’s legal representative;
  • appointment of a new chief investigator
  • a change to the insurance or indemnity arrangements for the study;
  • inclusion of a new trial site (not listed in the original application) in a CTIMP;
  • appointment of a new principal investigator at a trial site in a CTIMP;
  • temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt;
  • a change to the definition of the end of the study;
  • any other significant change to the protocol or the terms of the REC application.
Examples of non-substantial amendments:

  • minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;
  • updates of the investigator’s brochure (unless there is a change to the risk/benefit assessment for the trial);
  • changes to the chief investigator’s research team
  • changes to the research team at particular trial sites (other than appointment of a new principal investigator in a CTIMP);
  • changes in funding arrangements;
  • changes in the documentation used by the research team for recording study data;
  • changes in the logistical arrangements for storing or transporting samples;
  • inclusion of new sites and investigators in studies other than CTIMPs;
  • extension of the study beyond the period specified in the application form.

Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or other study staff are minor amendments but should be notified to the REC that approved your original application.

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