Form 30 CIRB CR Application

CIRB CONTINUING REVIEW APPLICATION
Attachment_B14_CR_App

OMB #0925-0753 Expiration Date: 06/30/2020

The purpose of the information collection is to conduct reviews of clinical trial studies. NCI guidelines mandate the participation of
institutions in the CIRB for Network group studies. You are being requested to complete this instrument so that we can conduct
activities involved with the operations of the NCI CIRB Initiative. Although your participation in Network group research and
completion of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The
information you provide will be combined for all participants and reported as summaries. It will be kept private to the extent
provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 15 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 (0925-0753). 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:
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
Number
CONTACT PERSON (Person to contact with questions about this application)
Name
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Title
Institution Name
Phone Number
E-mail
Provide a list of all individuals to be copied on CIRB outcome letters addressed to the Study
Chair.
Name

E-mail

Please remember to notify the CIRB if this list updates throughout the approval period in order to ensure
all necessary parties receive the proper correspondence from the CIRB.

1.0

CIRB Study Status
1.1

Check the appropriate box below to indicate the CIRB study status. Please note
that CIRB study status definitions differ from CTEP/DCP study status definitions.
1.1.1

Active: The study has received full approval from CTEP/DCP 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 been fully approved
by the CIRB, but 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:
Describe reason for Temporary Closure:

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:
Describe reason for Temporary Closure/Intervention Suspension:

1.1.5

Version Date 07/26/17

Closed to Accrual, Participants Receiving Intervention: The study
has permanently closed to accrual, however enrolled participants are still
receiving study intervention.
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Closure to Accrual Date:
Number of participants on study intervention:
1.1.6

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.
Closure to Accrual Date:
Number of participants 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 completed with the CIRB only when it has
finished its planned course and all of the following are true.
a. The study has been permanently closed to accrual at all study sites.
Yes
No
b. All study participants have completed study intervention and
interactions at all study sites.
Yes
No
c. All study-related collection of identifiable private information about
the participants is complete at all study sites.
Yes
No
d. Analysis of identifiable data is complete at all study sites.
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 study report/publication.
If all of the above questions have been answered “Yes”, the study will be
permanently closed with the CIRB. 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 complete with the CIRB if the study was stopped earlier
than planned and all of the following are true.
a. The study has been permanently closed to accrual at all study sites.
Yes
No

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b. All study participants have completed study intervention and
interactions at all study sites.
Yes
No
c. All study-related collection of identifiable private information about
the participants is complete at all study sites.
Yes
No
d. No further study activity or data analysis will be performed at any
study site.
Yes
No
If all of the above questions have been answered “Yes”, the study will be
permanently closed with the CIRB.
State why the study was stopped earlier than planned:
Go to Section 2.0 and complete the rest of the form as a final report to
the CIRB.
1.2

For multiphase studies provide a summary of the study progress (i.e. completed
phase I). Include which phase/stage of the study is currently active and the future
timelines for moving into additional phases or expansion cohorts if applicable.

N/A
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 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:

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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
Female
Male
Reported

Hispanic or Latino
Unknown
/ Not
Female Male
Reported

Unknown/Not Reported
Ethnicity
Unknown
/ Not
Female Male
Reported

Asian

Native
Hawaiian or
Other Pacific
Islander
Black or
African
American
White

More Than
One Race

Unknown or
Not Reported

Total

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?

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Total

3.0

Other Study Information
For the following questions include new relevant information that has become available
since the last continuing review approval, or initial review approval if this is the first
review for continuation,
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.
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? 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?
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)/Package Insert been updated?
Yes

No

No IB/Package Insert

If Yes, please provide the drug name and the version date of the most current
IB(s) being used:
3.5

Have 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 changed?
Yes

Version Date 07/26/17

No
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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 Coordinating Group
Randomized Phase 2 and Phase 3 Clinical Trials?
Yes

No

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
For the following questions include new relevant information that has become available
since the last continuing review approval, or initial review approval if this is the first
review for continuation,
4.1

How is the study monitored for safety?
Data and Safety Monitoring Board (DSMB)
Safety monitoring committee
Other, explain.
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:

4.1.3 If no DSMB is being utilized, state when and how the continued progress
of the study was last monitored/reviewed and state results from that
discussion.

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.
4.3

For Phase I or I/II studies, have any Dose Limiting Toxicities (DLTs) occurred?
Yes

No

Not applicable

If Yes, did these DLTs cause a change in the accrual status?
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Yes

No

Not applicable

If Yes, explain.
4.4

For Phase I or I/II studies, provide the following information related to Adverse
Events which have occurred to date (a table may be attached if available):
Not applicable (skip to question 4.5)
Number of participants reporting AEs:
Of the reported AEs provide the following:
Number of Grade 3:
Number of Grade 4:
Number of Grade 5:
For each Grade 3, 4 or 5 AE summarize in which cohort and dose level the
AE’s occur. Note if Dose Limiting Toxicity (DLT) was a factor. (e.g.
grade 4 oral mucositis, cohort 3, 10 mg/m2):

4.5

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.
4.6

Have there been any unanticipated problems?
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.
4.7

Has anything occurred to cause the risk-benefit assessment to change?
Yes

No

If Yes, explain.

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Summary of CIRB-Requested Supporting Documents
Protocol upon which this application is based
Consent form(s) with the same Protocol Version Date as the protocol
Relevant information relating to participants’ risks and benefits (Question 3.2)
Provide the following materials 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)
Email the completed application and the required supporting documents to
[email protected], [email protected], [email protected], or
[email protected].

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