If you are required to make any changes to information or documents by a review body please seek advice from them on whether you can respond to issues in correspondence or need to re-submit a form or documents. It is important that you share this information with all the other bodies that are reviewing your study.
For clinical trials of investigational medicinal products, the way in which information is supplied following review is set out below:
- if the outcome of the MHRA assessment is acceptance of the request with conditions applied and the conditions are met, it is not necessary to confirm to MHRA that the conditions are met but it may be appropriate to provide any relevant clarifications to other review bodies to avoid confusion
- if the outcome of the MHRA assessment is acceptance of the request with conditions applied and the conditions are not met, the sponsor should submit a substantial amendment supported by the relevant documentation to make the necessary changes. The substantial amendment should be submitted to other review bodies in accordance with the guidance in the relevant section of this website.
- if the outcome of the REC, HRA or R&D review is that changes to the application or documents are required, they are termed ‘revisions’, and are not handled as amendments. However, if these revisions meet the criteria for substantial amendments that require notification to MHRA, they must be submitted to MHRA in accordance with the amendments process.
If you feel that you are being given contradictory responses from different review bodies, please ask for an explanation of the requests. Sometimes there can be a number of options for addressing an issue with a study, and it will be possible to agree a solution between the review bodies.