Annual Renewal Form ~ July 08
IRB PROTOCOL SUPPLEMENT
ANNUAL PROTOCOL RENEWAL
Status & Information Update
NOTE: For processing, submit this completed form along with your
Progress Report and current Consent Forms to:
Cat Runden, Office of Research Compliance, 326 Cameron Hall
Call 704-687-1871 if you have questions.
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Annual Renewal Form ~ July 08
Easy to Use Template InstructionsSimply tab to the gray blocks and type in your information. The box or text area will expand as you type.
To select a box (*) of your choice, simply point the mouse to the box and click!
Date Submitted:
SECTION I. APPLICATION INFORMATION
Primary
Investigator: / Protocol No.:
Assigned by ORS
Department: / Phone: / Fax:
Address: / E-mail:
Project Title:
Co Investigator(s)
NOTE: Federal regulations require an annual continuing review of approved projects. If you have submitted requests for amendments or changes to your protocol, please submit an updated IRB Protocol Application along with this completed questionnaire prior to your anniversary date.
PLEASE COMPLETE ALL SECTIONS BELOW!
SECTION II. STATUS OF RESEARCH
Terminated
OR
Active
SECTION III. CHANGES IN THE PROTOCOL : ANSWER ALL QUESTIONS
1. Have there been any procedural changes from the originally approved protocol?
No
Yes
If yes, please explain and submit an updated IRB Protocol Application along with this questionnaire:
Have the changes been approved? If “yes,” please attach IRB Approval letter with Renewal Form.
No
Yes
2. Have any adverse events or unanticipated risks to subjects or others?
No
Yes
If yes, please explain:
3. Have any of the subjects withdrawn from the research?
No
Yes
If yes, please explain:
4. Have you had any complaints about the research?
No
Yes
If yes, please explain:
5. Have any co-investigators been added or deleted?
No
Yes
If yes, please explain:
6. Progress/Final Report
Please briefly describe the progress of the study to date. If you are terminating the study, please submit a brief Final Report.
SECTION IV. Subjects in the study
Please complete the following questions related to the subjects in your study. Provide as much information as possible. If you did not collect specifics regarding gender or ethnicity, please indicate this with “N/A” in the total columns for Female and Male. Then indicate the Total number of participants in your study for the past year.
1. Please provide the number of subjects in the study on the following table.
American Indian or Alaskan Native / Asian orPacific Islander / Black (not of Hispanic origin) / Hispanic / White (not of Hispanic origin) / Unknown or Not Applicable (please explain) / Total
Female
Male
Unknown or
Not Applicable
Total
2. Do you plan to enroll more subjects?
No
Yes
SECTION V. INFORMED CONSENT—Do not Submit if you are terminating the study
Submit a copy of the informed consent document which you will be using during the upcoming approval period.
The document should reflect any amendments or changes which have been made to the protocol (e.g. increase/decrease in number of participants, changes in procedures, changes in risks, etc.)
SECTION VII. FUNDING
1. Is this project funded?
No
Yes. Agency:
Grant #:
Title:
SECTION VIII. ASSURANCES & APPROVALS
Renewal Assurance Statement
Protocol Title:
Protocol #:
Date Annual Renewal Application Submitted:
I acknowledge responsibility for the conduct of these procedures involving human subjects and attest to the accuracy and completeness of the information provided. I agree to conduct this work in accordance with university and federal guidelines as approved by the UNC Charlotte IRB and with the assurance that the proposed work does not unnecessarily duplicate that of any other project. I agree that all personnel involved in this summary will be properly trained before being added to the protocol. Changes in the protocol will not be implemented without first obtaining the approval of the IRB.
Principal Investigator (Please print name)
Signature of Principal Investigator Date
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