Below is a listing of all the questions asked in the amendment application. The questions are sorted by screen and many will not be required for your specific study. 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 indicate the study documents that require revisions, or that will be added to the study as a result of this amendment. Please attach the documents that require revision or that will be added to the study to the modified protocol
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision (Include any Assent Form or Information Sheet changes)
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Do any of the new participating study investigators (or their immediate family/significant other) have a financial and/or intellectual interest in the sponsor or products used with this project
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision
Please describe each of the changes to the previously approved protocol and provide sufficient information about each change to allow the IRB/Reviewer to make a decision