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Amendments

Once your study has been approved you must keep the sponsor and all relevant review bodies informed of any changes to the study. Changes to the study are defined as either substantial or non-substantial. Substantial amendments require approval (from the relevant bodies) before they can be implemented except in the case of Urgent Safety Measures.

For all studies, it is the responsibility of the sponsor to determine whether an amendment is substantial and confirm which approvals are required (prior to any submission being made by the delegated responsible party). 

The interactive flow diagram below demonstrates the amendment process for research sponsored by a Noclor partner. Click on the section of interest to reveal details of the process. You can close the box with the x or by clicking on another section.  You can print off a copy of the whole process by clicking on the printer icon.

 

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