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Amendment Application Questions and Guidance

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
Guidance
1.1. Identifier for this Amendment Guidance
1.2. Type of Amendment(s) (check all that apply) Guidance
1.2.1. If Other type of amendment, please specify Guidance
1.3. 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 Guidance
1.3.1. If Other study document, please specify Guidance
1.4. Should current subjects be informed of the changes and their consent re-obtained? Guidance
2. Administrative (editorial changes)
2. 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 Guidance
3. Consent Form and/or Consent Form Addendum
3. 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) Guidance
4. Drug or Device
4. 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 Guidance
5. Investigators
5.1. New Principal Investigator Guidance
5.1.1. If a new Principal Investigator is being appointed, the new PI should read and certify the Assurance below Guidance
5.2. Indicate the current Co-Investigators to be removed from the study Guidance
5.3. Indicate Co-Investigators that will be added to the study Guidance
5.4. 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 Guidance
5.4.1. If yes, attach a completed Financial and Intellectual Interest Disclosure Form for each person who has a potential conflict to be managed Guidance
6. Number of Subjects
6. 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 Guidance
7. Procedures
7. 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 Guidance
8. Recruitment Materials
8. 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 Guidance
9. Study Contact Person or Coordinator
9.1. New Study Contact Person or Coordinator Guidance
9.2. Other Study Staff to be removed from the study Guidance
9.3. Other Study Staff to be added to the study (who may have access to online application and study materials) Guidance
10. Survey Instrument/Questionnaires/Psychological Tests
10. 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 Guidance
11. Risks/Harms
11. 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 Guidance
12. Study Population
12. 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 Guidance
13. Other
13. 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 Guidance
99. Modified Study Link
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