IRB Amendment and Renewal Request & Monitoring Form

Name Name First Last
IRB Study Name
IRB Protocol Number
Email
Type of Request:

Type of Request: Amendment Renewal Monitoring Report as requested by IRB
1. Have there been any research-related problems,complications, or mishaps affecting the research subjects since the last IRB review? Unanticipated adverse events must be reported via Adverse Event form.

1. Have there been any research-related problems,complications, or mishaps affecting the research subjects since the last IRB review? Unanticipated adverse events must be reported via Adverse Event form. No Yes (Describe below any changes in the research rise to the human subjects)
2. Has the nature of the contact with human subjects changed since the last review? If yes,does this increase the research risk to the subjects?

2. Has the nature of the contact with human subjects changed since the last review? If yes,does this increase the research risk to the subjects? No Yes (Explain below the change and increased risk in detail)
Supporting Documentation

Attach Files
3. Has the study method or sampling plan (data collection methods or instruments; size, sex, or age of the target population) been altered ?

3. Has the study method or sampling plan (data collection methods or instruments; size, sex, or age of the target population) been altered ? No Yes (Explain alterations in detail below)
4. Has the environment for subject contact been changed or altered?

4. Has the environment for subject contact been changed or altered? No Yes (Explain alterations in detail below. Include as an attachment the approval of QI project from host facility or letter of commitment from administrative representative of the facility that indicates intent of facility to participate in and host this project)
Facility Approval/Letter of Commitment

Attach Files
5. Have the investigators or persons having contact with the subjects or subject data changed?

5. Have the investigators or persons having contact with the subjects or subject data changed? No Yes (Explain in detail below. List both the NEW investigators and those NO LONGER serving as investigators)
6. Have all subjects in the study signed the consent form?

6. Have all subjects in the study signed the consent form? No (Explain in detail below) Yes
7. Have there been problems associated with obtaining informed consent?

7. Have there been problems associated with obtaining informed consent? No Yes (Explain in detail below)
8. Is a copy of each signed consent form on file, stored in a secure manner, and available for review by appropriate authorities?

8. Is a copy of each signed consent form on file, stored in a secure manner, and available for review by appropriate authorities? No (Explain in detail below) Yes
9. Has work with human subjects been completed? If yes, enter date completed in box below.

9. Has work with human subjects been completed? If yes, enter date completed in box below. No (Explain in detail below) Yes (Enter date completed below)
10. Do you want the IRB to close this file? If yes, complete Closure Report.

10. Do you want the IRB to close this file? If yes, complete Closure Report. No (Describe reason for requesting continuation below) Yes (Complete Closure Report)
11. Signature
I certify that the above statements and attachments (if needed) concerning this research are true.

Draw or Type

I understand this is a legal representation of my signature. Clear

Full Name

I understand this is a legal representation of my signature.