IND Safety Reports Tutorial IND Safety Reports that do not involve changes to the consent form and/or protocol do not need to be submitted as a Further Study Action (FSA). A "Submit IND Safety Reports" activity has been created to perform this function. It is located under "Current New Application Activities" on the Left Navigation Bar of the Summary View for the application. If you are submitting IND Safety Reports with NO changes to the protocol or consent form(s) you may upload more than one report. Be sure to enter the IND Safety Report numbers and any other important relevant information into section 2.0 of the activity. The informtaion entered in this section will be included in the acknowledgment email you receive from the IRB. This will be the only acknowledgment you receive. The HIstory Log will record the IND Safety Report submission and acknowledgment. Safety reports are not reviewed by the JHM IRB. Note: If you are submitting IND Safety Reports with changes to the protocol or consent form(s), you MUST submit a Further Study Action. | 
