Application for Approval for Research Involving Human Subjects CONTINUING REVIEW REQUEST / CLOSURE REPORT	New IRB#: _____________
Submission Procedures
Every Continuing Review Request must include a summary protocol of current research procedures Any changes made to the approved protocol must be accompanied with a Request for Modification Investigator must submit most recent application, signature page and any accompanying documents electronically via email to irb@chapman.edu Application and informed consent forms must be submitted in a Word document For any questions, please refer to the IRB website or contact the IRB staff at irb@chapman.edu or (714)628-7392.
Continuing	Closure (Completed)	Terminated
IRB#	Category:	Expedited	Full	Note: exempt research does not qualify for continuation
Protocol Title:
Today’s Date:	Protocol Expiration Date:	Most Recent Modification Approval Date:
Externally Funded?	Yes No	Study Sponsor:	Award #

Chapman Principal Investigator (Faculty/Academic Professional Staff/Faculty Advisor):
This is a Student-Directed Project and I am serving as Faculty Advisor
Name & Title:	Email:
Institute/Center/Department:
School/College:	Phone:

Student Investigator (Complete only if Student-Directed Project – MUST have Faculty Advisor listed above):
Graduate	Undergraduate	Program/Major:
Name:	Email:
Institute/Center/Department:
School/College:	Phone:

Materials and Procedures. Check all that apply.
PROTOCOL SUMMARY: Required
A written summation describing the research, test measures, procedures, recruitment process, and any other pertinent information about the protocol. Attach in a separate document. Do NOT attach previous applications.
Have any members of the research team been added or removed since last approval or modification?
CONSENT FORMS:
Informed consent (18+)	Child assent form	Passive consent (waiver of written consent)
Have ANY changes been made to consent forms since last approval/modification?
INTERVIEW(S):
Simple	Audio-Recorded Interview	Video-Recorded Interview
Have ANY changes been made to interview format since last approval/modification?
SURVEY(S)/QUESTIONNAIRES(S) How is it administered?
Written	Computer-Administered	Web-Administered
Have ANY changes been made to survey(s)/questionnaire(s) since last approval/modification?
Additional procedures:
Access to personally identifiable information or decoded identification
Vulnerable population (prisoners, children, pregnant women, diminished capacity)
Video-Recorded Procedure(s)
Deception
Recruitment Advertisement(s)
Have ANY of the additional procedures been removed/added since last approval/modification?
Any other supplementary documentation. Please describe:
*Indicates a modification of approved protocol. Therefore, a Request for Modification must accompany this application along with additional documents of tracked changes or revisions.

RESEARCH TEAM: Please list all remaining members of the research team, including their current contact information, role on the project, training and access to Human Subjects. All researchers who have access to human subjects should be listed on the informed consent document. Please attach another sheet if necessary.

Chapman Researchers
Name	Email	Phone	Role	Access to Subjects?	Training (CITI, NIH, Other)

Non-Affiliated Researchers (Non-Chapman Team members)
Name	Institution	IRB Approval?	Email	Phone	Role	Access to Subjects?

1) STATUS OF RESEARCH PROTOCOL/PROJECT:
If the research is “Continuing”, you MUST provide an updated protocol summary (description of all research procedures). Do NOT attach previous applications.
1a)	Is subject enrollment continuing?	Yes	No
If Yes, new, updated, clean copies of the consent forms are required to continue subject enrollment.*
1b)	Are subjects being seen for follow-up?	N/A	Yes	No
1c)	Based on study results, has the risk/benefit ratio changed for this study?	Yes	No
If yes, explain:
1d)	Has there been a change in the PI, or the PI’s role in the study?	Yes	No
If yes, explain:
1e)	Has there been a change in the PI’s duties at Chapman University?	Yes	No
If yes, explain:
1f)	Have the physical or financial resources that are available to the study decreased since the last review?	Yes	No
If yes, explain:
1g)	Has there been any change in research staff since the last review?	Yes	No
1h)	Do you wish to make any changes in research staff at this Continuing Review?	Yes	No
If yes, please indicate the type of change that you are requesting, the name of the individual(s) and the training and qualifications of the individual(s) on the IRB Form “Request for Modification of Approved Project” and attach with this submission
*Note: If an individual obtains informed consent independently of an investigator, they must be identified on the research application and consent form and have completed an approved training program. Documentation of training must be kept on file by the investigator with a copy to the IRB.

2) MODIFICATIONS:
2a)	Have any modifications to the protocol (including sponsor amendments) been approved since the last review?	Yes	No
If yes, summarize the nature and purpose of all protocol modifications made since the time of last review:
2b)	If Continuing Review, are you submitting any modifications to the protocol (including sponsor amendments)?	Yes	No
If yes, summarize and include IRB Form “Request for Modification of Approved Project” with this submission

3) STATUS OF SUBJECTS:
3a)	Number of subjects enrolled in study since last report:	Since project began:
3b)	Number of female subjects since last report:
3c)	Number of minority subjects since last report:
3d)	Number of subjects who signed consents but were dropped from study since last report:
3e)	Total number of patients who withdrew or were withdrawn from the study since last report:
Summarize the reason(s) for withdrawal:
3f)	Number of subjects considered part of a vulnerable population since last report:
Indicate the reason(s) subjects were considered part of a vulnerable population (if applicable):
How do you continue to protect the vulnerable population? (if applicable)
3g)	Did all research subjects give written informed consent since last report?	Yes	No
If no, explain:

4) SERIOUS AND/OR UNANTICIPATED ADVERSE EVENTS:
4a)	Have there been any complications, untoward side effects, serious adverse events (SAE), or unexpected adverse events at this site since the last report?	Yes	No
If yes, have all events been reported to Chapman, FDA or Study Sponsor?	Yes	No
Summarize all events that occurred (if any) and describe the outcome(s)(what was done to resolve the event(s):
Is/are the subject(s) continuing in the research?	Yes	No
4b)	Have you received an SAE or an IND/IDE safety report from the FDA or Study Sponsor since last report?	Yes	No
If yes, have all non-local events been reported?	Yes	No

5) UNANTICIPATED RISKS OR SIGNIFICANT NEW FINDINGS:
Have unanticipated risks or significant new findings been discovered since the last review that might affect the subject’s willingness/consent to continue participation?	Yes	No
If yes, complete the following:
5a)	Explain the risks or findings in detail:
5b)	Do these or findings require modification to the informed consent form?	Yes	No
If yes, have the modifications been submitted to the IRB?	Yes	No
5c)	Were subjects notified of these risks or findings?	Yes	No
5d)	Have subjects given consent again?	Yes	No

6) UNANTICIPATED PROTOCOL DEVIATIONS
Did any unanticipated protocol deviations (including errors and/or accidents) occur since the last review?	Yes	No
If yes, summarize all protocol deviations:

7) ADVERTISING/RECRUITMENT
7a)	Were there any changes to the planned advertising or recruitment methods described in the original protocol since the last review?	N/A	Yes	No
If yes, summarize all changes that occurred AND submit the revised flyer or advertising materials to the IRB with this application.

8) DATA STORAGE
Have there been any changes to how information is stored since the last review?	Yes	No
If yes, explain:

9) RESOURCES (Pharmacy, Laboratory, Radiology)
Has there been any change in the use of pharmacy, laboratory, or radiology resources of the facility for procedures or tests that are not clinically indicated?	N/A	Yes	No
If Yes, you must complete the Impact Estimation Worksheets.

10) EXTERNAL STUDY MONITOR VISITS
Have you had any external study monitor visits since the last review?	Yes	No
If yes, were there any serious findings or concerns identified by the monitor?	Yes	No
If yes, explain:
If yes, please attach all Study Monitor Reports and Follow-up Memos with this Continuing Review submission

11) AUTHORED PUBLICATIONS
Has the Principal Investigator been an author or co-author on any published or submitted articles relative to this project/protocol since the last continuing review of this project?	Yes	No

12) FINANCIAL CONFLICT OF INTEREST
Since last reported, has there been any change in the financial interests of the Principal Investigator, any Co-investigator, or their spouse or dependent child(ren) with respect to the sponsor or other entity external to Chapman whose business interests are related to the data or results of this study?	N/A (unfunded)	Yes	No
If yes, describe in detail the change in financial interest:

13) PROGRESS REPORT (Must be completed to be accepted for review)
Provide a description of study progress, number enrolled, subject experiences, research results obtained thus far, any complaints about research, summary of subject benefits, any new scientific findings (or relevant recent literature available), and any new information since the IRB’s last review.

PRINCIPAL INVESTIGATOR’S ASSURANCE STATEMENT & SIGNATURE PAGE

This page is to be read and signed by the Faculty/Academic Professional Staff member acting as principal investigator or faculty advisor for a student-directed project AND the principal investigator’s department chair or supervisor.
Principal Investigator (Faculty/Academic Professional Staff/Faculty Advisor)
I certify that the information provided in this application is correct and complete. I have read and understand Chapman University’s policies concerning research involving human subjects and I agree to comply with all IRB policies, decisions, conditions, and requirements and that all procedures will meet relevant local, state and federal regulations regarding the use of human subjects in research.
Name of Principal Investigator (Please Print)
Signature of Principal Investigator	Date