CHOC, Memorial Care Health System and UCI (CMU) IRB Reliance
RELYING INVESTIGATOR (RI) APPLICATION FOR CONTINUING REVIEW
The RI is to complete this application at the time of continuing renewal and provide it to the Project Principal
Investigator (PPI) for submission to the Reviewing IRB. The RI must not continue research at their respective
institution until the Relying IRB has issued an IRB Reliance Letter and releases the institution specific IRB
approved documents to the RI.
Attached to this application the RI may need to include:
 IF APPLICABLE: A Data Safety Monitoring Report
 IF APPLICABLE: Any Audit Reports
 UPON IRB REQUEST: A signed copy of the most recent consent document. The consent document
must include the Cover Letter, Part A and Part B.
SECTION A: PROJECT INFORMATION
Title:
Reviewing IRB Protocol Number:
CHOC
MHS
UCI
Relying IRB Protocol Number:
CHOC
MHS
UCI
RI Name:
SECTION B: RI SITE PROGRESS REPORT
1. Current Study Status.
Please mark the option that best represents the current status of this study at the RI site.
Remember, when a subject has enrolled, they have signed a consent form – even if they later withdraw or are
withdrawn by the research team (e.g., determined to be a screen failure).
No subject enrollment. Enrollment has not begun. No consent forms have been signed.
If enrollment has not begun specify why below:
Subject enrollment and research procedures are ongoing.
Subject enrollment is complete. Research procedures are ongoing.
Subject enrollment and research procedures are complete. Subjects are on standard care or undergoing
follow up.
Subject enrollment and research procedures are complete. Analysis of identifiable data is ongoing.
2. Study Progress.
Please provide a detailed description of the progress of the study at the RI’s site, including a brief summary of
any interim findings or trends. State the research team’s plans for the next approval period, including the
anticipated enrollment at the RI site.
Version: November 2014
Relying Investigator Application for Continuing Review
Page 1 of 4
3. Please review the completed RI Worksheet. Confirm that the information provided is current.
No changes are allowed with this form at continuing review, except for the removal of study staff. A separate
amendment is required to request changes.
The RI Worksheet is current. No changes are needed. The current RI Worksheet is attached to this
application.
The RI Worksheet has been updated to reflect the removal of study staff. The Updated RI Worksheet is
attached to this application.
4. Have there been any publications or presentations resulting from this study since last review?
Yes. Provide any citations below and provide a copy of each publication, as required by the Relying IRB.
No. The following text box may be left blank.
SECTION C: SUBJECT ENROLLMENT
If study enrollment has NOT begun, proceed to Section E.
5. Report the total number of subject (including specimens/records review) enrollments for the relying site.
Status of Enrollments
Total
Subjects screened, not yet active (consent signed)
Subjects active on study
Subjects on follow-up
Subjects withdrawn or screen failed
Subjects who completed study
Total number subjects consented (add rows above)*
For specimen/records review studies only:
Status of Enrollment
Total
Specimens/records screened, no data collected (consent signed, unless waiver granted)
Specimens/records reviewed, data collected
Total number of subjects consented, unless waiver granted (add rows above)*
*should not exceed total enrollment across all study sites
SECTION D: DEMOGRAPHICS OF ENROLLED SUBJECTS
If the study is NOT federally funded, proceed to Section E.
6. If the study is federally funded, report the demographic information for the subjects (including
specimens/records review) enrolled at the relying site below.
Racial Categories
American Indian/Alaska Native
Asian
Version: November 2014
Females
Males
Relying Investigator Application for Continuing Review
Total
Page 2 of 4
Native Hawaiian or Other Pacific Islander
Black or African American
White
Other or Unknown
Ethnic Category
Hispanic or Latino
Females
Males
Total
SECTION E: RISK / BENEFIT
7. Have subjects experienced any direct benefits?
Yes. Include a summary below.
No. Explain below.
No. The study does not anticipate direct benefit to subjects. The following text box may be left blank.
N/A - Not Applicable: No Subjects Enrolled. The following text box may be left blank.
8. Has the frequency or seriousness of the expected risks been greater than expected?
Yes. Include a summary below and indicate if any changes will be made to the study protocol or consent
document.
No. The following text box may be left blank.
N/A - Not Applicable: No Subjects Enrolled. The following text box may be left blank.
9. Have there been any unanticipated study-related problems that involve risks to subjects or others which
has not previously been reported to the PPI site?
Yes. Include a summary below and indicate if any changes will be made to the study protocol or consent
document.
No. The following text box may be left blank.
N/A - Not Applicable: No Subjects Enrolled. The following text box may be left blank.
10. Does this study have a Data Safety Monitoring Board?
Yes. Attach the most recent data safety monitoring reports received. If the most recent data safety
monitoring report is not attached, explain why below.
No. The following text box may be left blank.
11. Does scientific literature indicate changes in knowledge relevant to the conduct of the study?
Yes. Include a summary below. The summary should include a brief description of any changes in the
currently accepted therapy or practices used in this study.
Version: November 2014
Relying Investigator Application for Continuing Review
Page 3 of 4
No. The following text box may be left blank.
12. Given your responses for # 8 and # 9, have there been any new risks or new benefits identified that have
not previously been reported to the IRB?
Yes. Please clarify below.
No. The following text box may be left blank.
13. Have there been any internal (institutional) or external (FDA/ OHRP/Sponsor) audits since the last IRB review
of this study?
Yes. Clarify below and specify if the institution was notified of this audit. Attach the audit report. If the
audit report is not attached, explain why below.
No. The following text box may be left blank.
14. Have any changes been made to the IRB protocol or consent document or any other material seen by
subjects that has not previously been reported to the IRB?
Yes. Please clarify below and have the PPI submit an amendment to the Reviewing IRB.
No. The following text box may be left blank.
15. Is there any information you have not otherwise reported that further summarizes study activity to date?
For instance, information may include communications from the study sponsor addressing study wide issues
or progress.
Yes. Please clarify below. Include any additional information that further describes the research activity
to date which is not otherwise stated above.
No. The following text box may be left blank.
Thank you for taking the time to complete this application. Please submit this application to the PPI
for review and submission to the Reviewing IRB.
Version: November 2014
Relying Investigator Application for Continuing Review
Page 4 of 4