Reportable Event Application Questions and Guidance
Below is a listing of all the questions asked in the reportable event application. The questions are sorted by screen and many will not be required for your specific reportable event. The guidance links, presented to the right of the questions, will open the guidance window displaying IRB guidance and help on answering the specific question.
1. Project Identification Information
Title of the Protocol Principal Investigator Study Coordinator
Please provide a brief (less than 30 words) summary of the Internal Adverse Event. Include a description of the AE(s), what was done to treat it, whether the study drug or procedure was interrupted, discontinued, etc. and indicate outcome.
Please provide a brief (less than 30 words) summary of the Internal Adverse Event. Include a description of the AE(s), what was done to treat it, whether the study drug or procedure was interrupted, discontinued, etc. and indicate outcome.
If the sponsor of the study or the study protocol requires this report to be submitted, or if in your medical/professional judgment you believe that the IRB should review this event, please check here
Please attach any additional documentation such as reports received from the sponsor, MedWatch reports or reports sent to other entities regarding this event.