Amendments

If the University is the research sponsor, CTRG reviews and approves all amendments to protocols and associated documents before submission to regulatory bodies. This is essential in order for the University to fulfil its sponsorship role and to ensure that indemnity can accommodate the changes proposed. The decision as to whether an amendment is substantial or non-substantial is ultimately the sponsor's.

Examples of substantial and non-substantial amendments are available on the HRA website

In order for CTRG to review and approve both substantial and non-substantial amendments, amended text must be shown as a tracked change. 

Once the amendment is authorised by CTRG, you will need to send both tracked change and clean versions of documents to relevant review bodies. Details of where to submit your amendments can be found in the IRAS help section

SUBSTANTIAL AMENDMENTS

A substantial amendment is defined as change to the terms of the protocol or any other supporting documentation that is likely to affect to a significant degree:

  1. the safety or physical or mental integrity of participants
  2. the scientific value of the research
  3. the conduct or management of the research
  4. the quality or safety of any investigational medicinal product used

Addition of new sites, or appointment of a new principal investigator at an existing trial site (for CTIMPs only), are substantial amendments since they change the conduct or management of the research.

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  1. Complete the European Commission notification of a substantial amendment form 
  2. Submit to MHRA via the Common European Submission Platform (CESP) and send a single copy of the relevant form to the REC, together with associated documents
  3. You will receive a response from the MHRA within 35 days 
  4. If approval is not granted, submit amended application addressing grounds for non-acceptance
  5. Once REC favourable opinion, MHRA and HRA approval are granted, send details to R&D at sites and CTRG
  1. Complete the IRAS substantial amendment form and email it to the REC with associated documents
  2. If the REC responds with an unfavourable opinion, submit amended application addressing request for modifications
  3. Favourable opinion from the REC and HRA approval if relevant
  4. Send details of REC and HRA approvals to R&D at sites and CTRG
NON-SUBSTANTIAL AMENDMENTS

For all non-substantial amendments, please complete the non-substantial amendment form template.

If approval is required from HRA

 

  1. Submit the non-substantial amendment form, sponsor authorisation email, and any amended documents by email to the REC that originally reviewed the study

  2. You will receive a categorisation email
  3. Send details of the outcome to R&D at sites and CTRG

Information on HRA categorisation of amendment can be found in the IRAS help section.

 
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