FORM: Continuing Review Progress Report
NUMBER
HRP-212
DATE
02/03/2015
PAGE
1 of 4
Use for both continuing review and as a final report to close a protocol.
If modifications are being requested, submit HRP-213 Modification Form with submission.
IRB Number:
Protocol Name:
Principal Investigator Name, Email, Phone:
Primary Contact Name, Email, Phone:
Enrollment Status
1. a.) Indicate the total number of subjects to be enrolled1 that the IRB approved for this
UCD site:
study (If this study only involves a charts/records review or the examination of
Study wide:
biospecimen samples, and waiver of informed consent was granted by the IRB, please
proceed to #2).
b.) How many total subjects have been consented (Include screen failures, drop outs,
UCD site, since the study began:
withdrawn consent, lost to follow up, etc. in this number)?
Study wide, since the study began:
c.) Total number screen failures at a UCD site (Screen failures are considered to have
been consented, but did not meet formal inclusion and exclusion criteria, and are not
UCD site, since the study began:
scheduled to participate in the research in accordance with the protocol).
d.) How many total subjects have been enrolled cumulatively (Enrolled subjects are
considered to have been consented, met formal inclusion and exclusion criteria, and are
scheduled to participate/are participating/or have participated in the research in
UCD site, since the study began:
accordance with the protocol)? (i.e. Sections 1(b) – 1(c) = 1(d))
Study wide, since the study began:
Note: *If over-enrollment has occurred complete HRP-214 Reportable New Information
form and include with this submission.
Withdrew due to AE:
e.) Total number of subjects that discontinued prematurely from the study who were
enrolled at a UCD site (lost to follow up, withdrew consent, withdrawn due to an adverse
event (AE), etc.).
2.
+ Withdrew Consent:
+ Lost to Follow-Up:
+ Other (please explain):
= Total discontinued at a UCD site:
Studies Only Involving Charts/Records or Biospecimen Samples
a.) Indicate the total number of charts/records or biospecimen samples the IRB
UCD site:
approved for this study (N/A if #1 completed above).
Study wide:
b.) Indicate the total number of charts/records reviewed or biospecimen samples
UCD site, since the study began:
examined cumulatively (N/A if #1 completed above).
Study wide, since the study began:
Vulnerable Populations Enrollment
Total number of subjects enrolled at this investigator’s site(s) considered members of vulnerable populations:
Count an individual in only one category. If individuals qualify for more than one category, report them in a federally defined
vulnerable category, when applicable. See 45 CFR 46 subparts B, C and D for federal definitions of vulnerable populations.
Neonates of
Pregnant
Cognitively
Students/
Other/
Children
Fetuses
uncertain viability/
Prisoners
Women
Impaired
Employees
Unknown
Non-viable neonates
True
1
False
Current Protocol Status2
The protocol is permanently closed to enrollment at this institution.
All subjects enrolled at this institution have completed all protocol related interventions and interactions, including
interventions and interactions related to collection of long-term follow-up data.
No additional identifiable private information about the subjects is being obtained by this institution’s investigator.
Analysis of private identifiable information at this institution is completed. (This can be checked even if a statistical
center at another institution will analyze private identifiable information from subjects enrolled at this institution.)
If all above are checked "True", do you wish to close the study permanently?
Enrolled subjects are considered to have been consented, met formal inclusion and exclusion criteria, and are scheduled to participate/are
participating/or have participated in the research in accordance with the protocol.
2
This refers to the status of the protocol under the supervision of the investigator, not the status of the protocol at all centers.
FORM: Continuing Review Progress Report
NUMBER
HRP-212
True
False
DATE
02/03/2015
PAGE
2 of 4
Do not fill in this section if you checked "True" to close the study permanently.
The remaining protocol activities are limited to identifiable data analysis.
The protocol remains active only for long-term follow-up of subjects.
Financial Interest Declaration
 “Related Financial Interest” means any of the following interests in the sponsor, product(s) or service(s) being tested, or competitor of
the sponsor held by the individual or the individual’s immediate family that was received within the last 12 months or that you expect to
receive in the next 12 months:
o Ownership interest of any value including, but not limited to stocks and options, exclusive of interests in publicly-traded, diversified
mutual funds.
o Compensation of any amount including, but not limited to honoraria, consultant fees, royalties, or other income.
o Proprietary interest of any value including, but not limited to patents, trademarks, copyrights, and licensing agreements.
o Board or executive relationship, regardless of compensation.
o Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or
affiliated research institute, academic teaching hospital, or medical center.
 “Immediate Family” means spouse, domestic partner, children, and dependents.
Do you or any personnel involved in the design, conduct, or reporting of the protocol have a Related Financial
Yes
No
Interest, as defined above?
NA
Yes
No
If yes, were financial interest previously disclosed?
NA
Yes
No
If yes, has there been any change(s) in any of the investigator(s) financial interest within the last 12 months?
If yes to above, have you submitted new financial interest disclosure forms (e.g., 700-U, Form 800 and
NA
Yes
No
Supplemental Form) which can be found at the Office of Research Forms webpage?
If yes, please attach determination from the Conflict of Interest Committee (COIC).
The following questions refer to all sites involved in the protocol since last IRB
Yes
No
continuing review (study renewal)
Have subjects experienced any harms (unexpected or increased frequency and/or severity of expected)?
Have subjects experienced any benefits?
Have there been any unanticipated problems involving risks to subjects or others?
Have any subjects withdrawn, been discontinued or terminated early from the study?
Have any subjects or others complained about the protocol?
Have there been any publications in the literature relevant to risks or potential benefits?
Have there been any interim findings?
Have there been any multi-center trial reports?
Have there been any data safety monitoring board reports?
In the opinion of the principal investigator, have the risks or potential benefits changed?
Are there any problems that required prompt reporting that have NOT been submitted?
Have there been any regulatory actions that could affect safety and risk assessments?
Have there been any other relevant information regarding this protocol, especially information about risks?
Have there been any written reports from the study monitors?
Explanation of any “Yes” responses to items in above sections:
Type "N/A" if not applicable
Type "See Attached" if attaching a separate document addressing all "yes" responses
FORM: Continuing Review Progress Report
NUMBER
HRP-212
DATE
02/03/2015
PAGE
3 of 4
Federal regulations require the IRB to conduct continuing review (study renewal) at least annually. The
IRB requires information from the investigator to complete the continuing review process, and needs
sufficient time to conduct this review. If this report is not being submitted at least 45 days prior to the
study expiration date, please explain why the form was late, and provide a corrective action plan to
prevent the submission of late reports in the future.
Is this report being submitted past the administrative due date?
No
This report is being submitted at least 45 days prior to the expiration date.
This form was submitted late because:
If you are submitting this report after the date your study expired, were research-related activities conducted during the time
IRB approval of this research was expired?
Yes
No
If “yes,” what activities were conducted?
Yes
It is very important that you submit your study renewal documentation on or before the required administrative due date. To
obtain approval of study renewal you must develop a plan to ensure that you submit required reports. You must be able to follow
this plan because failure to submit required reports by the due date could lead to a determination of “Continuing NonCompliance,” which is a reportable determination. Please note that failure to receive the a courtesy renewal reminder from the
IRB is not justification for failing to submit you documents on time. Please document your plan here:
Federal regulations require the IRB to have a procedure in place to ensure that changes to approved
research are not initiated without first obtaining IRB approval unless, the change is necessary to eliminate
an apparent immediate hazard to subjects
Have any changes, revisions, modifications, or alterations to the protocol, research procedures, or research
documents been implemented since the last initial or continuing review (study renewal) without IRB review and
approval? If yes, please submit Form HRP-213 (Modification) and Form HRP-214 (Report of New Information) to
Yes
No
explain the changes, why they were made, and the corrective actions you have taken to prevent implementing
changes in research without IRB approval.
Brief Summary of the Progress of the Protocol
Type "See Attached" if attaching a separate document addressing each section below
1. Summarize the research activity since last continuing review approval.
2. Provide a summary of all Reportable New Information reported to the IRB during the current approval period/since last approval. This
summary should include the following: date the PI became aware of the event, date of IRB submission, brief description of information,
resolution/corrective action plan, and the IRB determination (sample document available).
3. If the Short Form was utilized during the current approval period/since last approval, identify the language and number of subjects that
were consented. If you anticipate regular recruitment of subjects speaking this language, identify your plan for the consenting process in
the Protocol/DOS, and attach the appropriate translated consent documents.
4. If the study is active, but closed to enrollment, clarify the remaining procedures for subjects still enrolled in the study intervention.
Indicate whether these procedures will be minimal risk and/or whether subjects could undergo the remaining procedures as part of
standard of care.
Provide one copy of the following documents:
 Copy of sponsor’s progress report or annual report, if available
 Point-by-point response (When in response to modifications to secure approval, deferral, or disapproval)
 Sponsor Fee Form, if applicable
FORM: Continuing Review Progress Report
NUMBER
HRP-212
DATE
02/03/2015
PAGE
4 of 4
Principal Investigator Acknowledgement
I will conduct this protocol in accordance with requirements in the INVESTIGATOR MANUAL (HRP-103) listed in the section “What are my
obligations after IRB approval?”
Principal Investigator Signature
Date
IRB Use Only
This delayed or expired protocol submission involves:
Non-compliance that is neither serious nor continuing – Please note that failure to comply with your preventive
action plan could result in a finding of continuing non-compliance, which is a reportable event for federally
funded research and research that is subject to FDA regulations.
Please note that you will receive a letter from the IRB if any one of the determinations below is made in response
to this report. These events are considered a reportable event. If the research is federally funded or subject to the
FDA regulations, the IRB will be required to report the funding to applicable regulatory authorities.
 Unanticipated problem involving risks to subjects or others
 Suspension or termination of IRB approval
 Serious non-compliance
 Continuing non-compliance
IRB signature
Date