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Research in Progress
Protocol Amendments
Research Ethics Committee Requirements
The main Research Ethics Committee provided a favourable opinion of the research must authorise substantial amendments to the study. Any amendments that are not considered substantial do not need to be reported to the REC. The Central Office for Research Ethics Committees has produced guidance on submitting protocol amendments and determining whether an amendment is substantial:
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MHRA Requirements
If the study is a Clinical Trial of an Investigational Medicinal Product, the MHRA as the competent authority under the Clinical Trials Regulations, must authorise the amendment. Please click on the following link that will take you to the appropriate section of the Clinical Trials Toolkit for guidance on submitting a substantial protocol amendment to the MHRA.
Sponsor Requirements
Please forward a copy of the protocol amendment to the Sponsor
of the study. If the Trust or University of Leeds is acting as the sponsor for
the study, please forward this report to the R&D
Department - see R&D Requirements below for further information.
R&D
Requirements
If there is any proposed change to a study protocol that will have an impact on Trust resources, R&D approval is required for the proposed change. With your permission we can obtain this information from the Research Ethics Committee notification of amendments.
The process for informing R&D of protocol amendments is as follows:
- Submit notification of protocol amendment on REC paperwork to R&D Department
- R&D review the proposed amendment to establish whether it will have an impact on resource use in the organisation
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Appropriate Directorate Research Lead is contacted by R&D to confirm approval of change to protocol and any impact on resources.
- R&D confirm approval of amendment in writing to Chief Investigator
If you are clear that the proposed amendment will impact on resource use, please contact your Directorate Research Lead directly and submit confirmation of their approval (letter or email) along with details of the protocol amendment to the R&D Department .
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