Form 30 CIRB CR Application

CIRB CONTINUING REVIEW APPLICATION
OMB#: 0925–xxxx Expiration Date: xx/xx/xxxx
Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the
NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing
from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected will be kept private
to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined
for all participants and reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with
the operations of NCI CIRB Initiative.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid
OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions
for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0625).
Do not return the completed form to this address.

This application has been designed to meet the regulatory requirements for review, so
answer each question as completely as possible.
• All answers must be in lay language.
• If an answer to any question cannot be provided, provide an explanation for the
missing answer.
• If you have any questions regarding the completion of this application, contact the
CIRB Helpdesk at [email protected] or 888-657-3711.
APPLICATION COMPLETION DATE:
STUDY ID NUMBER:
.

STUDY TITLE:
PROTOCOL VERSION DATE:
This application should be based on the current CIRB-approved Protocol Version Date.
STUDY CHAIR
Name
Institution Name
Phone Number
E-mail
Administrative
Assistant Name
Administrative
Assistant E-mail
Administrative
Assistant Phone
Numb
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CONTACT PERSON (Person to contact with questions about this application)
Name
Title
Institution Name
Phone Number
E-mail
1.0

CIRB Study Status
1.1

Indicate with a check mark the current study status as defined by the CIRB.
Please note that CIRB study status definitions differ from CTEP study status
definitions. The CIRB definitions are provided for your convenience.
1.1.1

Active: The study has received full approval from CTEP and the CIRB,
has been activated by the coordinating group, and the study is open to
accrual.
Initial Activation Date:

1.1.2

Approved but Not Yet Activated: The study has gone through CIRB
review and has been fully approved by the CIRB however it is not open to
accrual.

1.1.3

Temporarily Closed to Accrual: The study is not completed but is
temporarily not accruing participants. Participants currently enrolled in
the study continue to receive study intervention and/or are being followed.
Temporary Closure to Accrual Date:

1.1.4

Temporarily Closed to Accrual and Intervention Suspended: The
study is not completed but is temporarily not accruing participants.
Participants currently enrolled have had study intervention suspended.
Temporary Closure/Intervention Suspension Date:

1.1.5

Closed to Accrual, Participants still Receiving Intervention: The
study has permanently closed to accrual however enrolled participants are
still receiving study intervention.
Closure to Accrual Date:
Number of participants still on study intervention:

1.1.6

Version Date 12/02/13

Closed to Accrual, Participants have Completed Intervention: The
study is permanently closed to accrual and all participants have completed
study intervention. Participants are either in the follow-up phase or have
finished participation in the study.
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Closure to Accrual Date:
Number of participants still in follow-up:
1.1.7

Withdrawn: The study is withdrawn by the Study Chair prior to CIRB
final approval or withdrawn prior to activation by the coordinating group.
Once withdrawn, all study activity will be considered completed with the
CIRB. If the study is reactivated, it will have to be submitted to the CIRB
and reviewed as a new study.
Withdrawal Date:

1.1.8

Completed: The study is considered completed with the CIRB only
when it has finished its planned course and all of the following are true.
a. The study has been closed to accrual.
Yes
No
b. All participants have completed study intervention.
Yes
No
c. All participants have completed all follow-up activities.
Yes
No
d. Analysis of the data is complete.
Yes
No
e. The study has met its primary objectives and a final study
report/publication has been submitted.
Yes
No
If Yes, provide a copy of the final report/publication.
If all of the above five questions have been answered “Yes”, the study will
be permanently closed with the CIRB. Please go to Section 2.0 and
complete the rest of the form as a final report to the CIRB.

1.1.9

Administratively Completed: The study is considered
administratively completed with the CIRB when it has been stopped
earlier than planned and all of the following are true.
a. The study has been closed to accrual.
Yes
No
b. Participants are no longer receiving study intervention.
Yes
No
c. All follow-up activities have ceased.
Yes
No
d. No further activity or data analyses are being performed.
Yes
No
If the above four questions have been answered “Yes”, the study will be
permanently closed with the CIRB. Please state why the study was

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stopped earlier than planned then complete the rest of the form as a final
report to the CIRB.
2.0

Enrollment Information
2.1

Accrual target:
2.1.1
2.1.2
2.1.3
2.1.4
2.1.5

Number of participants enrolled:
Total number of participants currently receiving study intervention:
Total number of participants who completed study intervention:
Total number of participants still in follow-up:
Total number of participants whose study intervention was terminated
early or who have chosen to withdraw from the study:
Describe specific reasons for withdrawals or terminations:

2.2

Projected Enrollment Information at Study Institutions
2.2.1

Provide the protocol section and page number for the Targeted/Planned
Enrollment tables for ethnic and racial categories.

2.2.2

Are there zeroes in any of the categories in either chart?
Yes
No
If yes, provide a rationale for the exclusion:

2.3

Current Enrollment Information at Study Institutions
For your convenience, we have retained the NIH formatting so that you can easily
include the information in this application.
Cumulative Inclusion Enrollment Report

Ethnic Categories

Racial
Categories
American
Indian/Alask
a Native

Not Hispanic or Latino
Unknown
/ Not
Reported
Female
Male

Hispanic or Latino
Unknown
/ Not
Reported
Female Male

Unknown/Not Reported
Ethnicity
Unknown
/ Not
Reported
Female Male

Asian

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Total

Ethnic Categories

Racial
Categories
Native
Hawaiian or
Other Pacific
Islander

Not Hispanic or Latino
Unknown
/ Not
Female
Male
Reported

Hispanic or Latino
Unknown
/ Not
Female Male
Reported

Unknown/Not Reported
Ethnicity
Unknown
/ Not
Female Male
Reported

Black or
African
American
White

More Than
One Race

Unknown or
Not Reported

Total

3.0

2.4

How is overall study recruitment progressing compared to the intended schedule?
If concerns exist, what is the plan to address them?

2.5

How is recruitment to the ethnic and racial categories defined in the charts of
Section 2.3 progressing compared to the intended schedule as defined in the
charts of Section 2.2? If concerns exist, what is the plan to address them?

Other Study Information
3.1

Have any findings from this study been presented or published other than to a
Data and Safety Monitoring Board?
Yes

No

If yes, explain and attach the presentations or publications.

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Total

3.2

To the Study Chair’s knowledge, has any publication or other relevant
information relating to participants’ risks and benefits on this study become
available since the last CIRB review? This would include any new information
about the drugs or procedures used in this study, as well as any new information
on alternative therapies for the condition being studied.
Yes

No

If yes, explain and attach relevant documents.
3.3

Have there been any changes in the research activity, revisions, amendments, or
any editorial or administrative updates to the protocol, model consent form, or
study participant questionnaires since the last continuing review approval or
initial review approval if this is the first review for continuation?
Yes

No

If yes, please list all changes, revisions, amendments, and/or editorial or
administrative updates since the last continuing review approval or initial review
approval if this is the first review for continuation. Include the respective
Protocol Version Dates or Update Dates.
3.4

Has the Investigator’s Brochure (IB) been updated since the last continuing
review approval or initial review approval if this is the first review for
continuation?
Yes

No

Not applicable

Please provide the version date of the most current IB:
3.5

Have there been any updates or changes since the last continuing review approval,
or initial review approval if this is the first review for continuation, to the
financial conflict of interest disclosures of the Study Chair or any persons listed
on the protocol who are involved in the development or coordination of the study?
Yes

No

If yes, explain.
3.5.1

Do any of the updates or changes result in new or revised significant
financial conflicts of interest as defined in the National Cancer Institute
(NCI)/Division of Cancer Treatment and Diagnosis (DCTD) Conflict of
Interest Policy for NCI/DCTD-supported Cooperative Group Randomized
Phase 2 and Phase 3 Clinical Trials?
Yes

Version Date 12/02/13

No
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If yes, please provide a copy of the coordinating group’s management plan
to address the new or revised conflicts disclosed in question 3.5.
4.0

Adverse Event and Unanticipated Problem Information
4.1

How is the study monitored for safety?
Data and Safety Monitoring Board (DSMB)
Safety monitoring committee
Not applicable, explain.
4.1.1 Date of last DSMB or safety monitoring meeting:
Attach the current DSMB report supplied to investigators.
4.1.2 Date/approximate date of the next DSMB or safety monitoring meeting:

4.2

Has a toxicity summary report been prepared for the study?
Yes

No

Not applicable

If yes, attach a copy of the current toxicity summary report supplied to
investigators.
4.3

Since the last continuing review approval, or initial review approval if this is the
first review for continuation, have there been any incidents, experiences,
participant complaints, or outcomes that indicate participants or others may be at
greater risk of harm (physical or otherwise) than previously anticipated?
Yes

No

If Yes, explain.
4.4

Have there been any unanticipated problems since the last continuing review
approval or initial review approval if this is the first review for continuation?
Yes

No

If yes, has the unanticipated problem been reported to the CIRB?
Yes

No

If No, please provide a description of the unanticipated problem and any
corrective action plan implemented.

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4.5

Since the last continuing review approval, or initial review approval if this is the
first review for continuation, has anything occurred to cause the risk-benefit
assessment to change?
Yes

No

If Yes, explain.
Summary of CIRB-Requested Supporting Documents
Protocol upon which this application is based
Consent form with the same Protocol Version Date as the protocol
Relevant information relating to participants’ risks and benefits (Question 3.2)
The following materials are required, if applicable:
Presentations and publications for this study (Question 3.1)
Investigator’s Brochure (Question 3.4)
Management plan to address new or revised conflicts (Question 3.5.1)
Current DSMB/safety monitoring committee report (Question 4.1.1)
Current toxicity summary (Question 4.2)
Submit the completed application and the required supporting documents via email to
[email protected], [email protected] or [email protected].

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