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Research in Progress
Changes to the Research Team
Research Ethics Committee Requirements
If the Chief Investigator (CI) or local Principal Investigator (PI) is changed, please contact the main REC (i.e. the committee that provided the main ethical review of the study) to establish their requirements for reporting a change to CI or PI.
Changes to the research team other than the CI and PI are not considered substantial changes and do not need to be reported to the REC.
For REC contact details please click here
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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, requires notification of change of Chief Investigator as named on the Clinical Trial Authorisation. Please see the relevant section of the Clinical Trials Toolkit for further information.
Sponsor Requirements
Please inform the Sponsor or changes to the Chief Investigator (CI) or local Principal Investigators (PIs). This will allow the Sponsor to ensure that appropriate agreements, allocating responsibilities for the study can be put in place with the new CI or PI. Where the Trust or the University of Leeds is the Sponsor, please inform the R&D Department of the change.
R&D Requirements
Please notify the R&D Department of any changes to the local Research Team named on the original REC and LTHT R&D Approval application forms. This will allow us to extend NHS indemnity to the new members of the research team.
Please note that honorary contracts may be required for new
members of the research team. Please click
here for further guidance on honorary contracts
Addition of New Sites to the Study
Clinical Trials of Investigational Medicinal Products:
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Please see the appropriate section of the Clinical Trials Toolkit
All other research:
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If the Sponsor for the study is the Trust or the University of Leeds, please notify the R&D Quality Assurance Department. The R&D Department will then ensure that agreements allocating responsibilities for the research are put in place with the new site.
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If the Sponsor is not the Trust or University, please notify the Sponsor and the R&D Department.
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