After a protocol is approved, the investigator may find that it must be modified. Possible reasons include:
In these cases, the investigator may submit a request for a modification review (see Forms and Templates). In the request, the desired changed should be explained, as well as the reasons for making them. All revised IRB documents should be attached. For instance, if the recruiting information is being changed, the revised flyer, recruiting script or text should be submitted. Changes should be highlighted so that the IRB can compare the old and new documents. If the changes are substantive, or involve higher risk to the participants, a revised protocol which incorporates the changes should be generated and submitted.