33 Adult CR FB Reviewer Worksheet

NCI ADULT/PEDIATRIC CIRB APPLICATION
FOR
CONTINUING REVIEW
Attachment_B17_Cont_Rev

OMB#
0925-0753,
Expiration
Date: 07/31/2021
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 60 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, when completed, contains information required by CIRB members to conduct a
meaningful review of the study so answer each question as completely as possible. If an answer to any
question cannot be provided, please provide an explanation for the missing answer. If you have any
questions regarding the completion of this application, please contact the CIRB Helpdesk at 888-657-3711
or [email protected].
APPLICATION COMPLETION DATE:

GROUP STUDY ID NUMBER: $$Study ID$$
STUDY TITLE: $$Study Title$$

PROTOCOL VERSION DATE:
This application should be based on the current CIRB-approved Protocol Version Date. Please
provide the protocol and the informed consent document with this Protocol Version Date.
STUDY CHAIR
Name
Title
Institution/Address
Phone Number
E-mail
FAX Number
Administrative
Assistant Name
Administrative
Assistant E-mail
July 2018

$$Study Chair name$$, $$Study Chair Degree$$
$$Study Chair Address$$
$$InvestPrimaryPhone$$
$$InvestEmail$$
$$InvestFAX$$

Administrative
Assistant Phone
Number

STUDY CO-CHAIR (If applicable)
Name
Title
Institution/Address
Phone Number
E-mail
FAX Number
Administrative
Assistant Name
Administrative
Assistant E-mail
Administrative
Assistant Phone
Number

CONTACT PERSON (Person to contact with questions about this application)
Name
Title
Institution/Address
Phone Number
E-mail
FAX Number
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
1.1.2
1.1.3

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

Approved but Not Yet Activated: The study has gone through CIRB review and has
been fully approved by the CIRB however it has yet to be activated by the Cooperative
Group.
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:

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1.1.4

1.1.5

1.1.6

1.1.7

1.1.8

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:

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:

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 still in follow-up:

Withdrawn: The study is withdrawn by the Study Chair prior to CIRB final approval
or withdrawn prior to activation by the coordinating Cooperative 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:

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
b. Participants are no longer receiving study intervention.
Yes
No

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No

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c. All follow-up activities have ceased.

Yes
d. No further activity or data analyses are being performed.
Yes

No
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 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
For your convenience, we have retained the NIH formatting so that you can easily include the information in
this application.
2.2.1

Describe the target population in terms of ethnicity:

TARGETED/PLANNED ENROLLMENT: Number of Subjects
Ethnic category

Sex/Gender
Females

Males

Total

Hispanic or Latino
Not Hispanic or Latino
Ethnic Category Total

2.2.2

Describe the target population in terms of race:

TARGETED/PLANNED ENROLLMENT: Number of Subjects
Sex/Gender
Racial Categories

Females

Males

Total

American Indian /Alaska
Native
Asian
Black or African American
Native Hawaiian or Other
Pacific Islander

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White
Racial Categories: Total of
all Subjects

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.
PART A. TOTAL ENROLLMENT REPORT: Number of Participants Enrolled to Date (Cumulative)
by Ethnicity and Race
Ethnic Category

Females

Sex/Gender
Unknown or
Males
Not Reported

Total

Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals not reporting ethnicity)
Ethnic Category: Total of All Participants*
Racial Categories
American Indian/Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
More than one race
Unknown or not reported
Racial Categories: Total of All Subjects*

PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date
(Cumulative)
Racial Categories

Females

Males

Unknown or
Not Reported

Total

American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
More Than One Race
Unknown or not reported

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Racial Categories: Total of Hispanics or
Latinos**
*These totals must agree.

**These totals must agree.

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?

3.0

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

3.2

If yes, explain and attach the presentations or publications.

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

3.3

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

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

3.5

No

If yes, explain and attach relevant documents.

Yes

3.4

No

No

Not applicable

Please provide the version date of the most current IB:

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

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disclosures of the Study Chair or any persons listed on the protocol who are involved in the
development or coordination of the study?
Yes

If yes, explain.
3.5.1

No

Do any of the updates or changes result in new or revised significant financial conflicts of
interest as defined in the Conflict of Interest Policy for Cooperative Group Phase 3
Clinical Trials?
Yes

No

If yes, please provide a copy of the Cooperative 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.

4.2

4.3

4.1.2 Date/approximate date of the next DSMB or safety monitoring meeting:
Has a toxicity summary report been prepared for the study?
Yes

No

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

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

4.4

If Yes, explain.

No

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

July 2018

Not applicable

No

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

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Yes

4.5

No

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

If Yes, explain.

No

Summary of CIRB-Requested Supporting Documents Required, if applicable
Protocol upon which this application is based
Informed consent document with the same Protocol Version Date as the protocol
Presentations and publications for this study (Question 3.1)
Relevant information relating to participants’ risks and benefits (Question 3.2)
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)

Thank you for completing the NCI Adult/Pediatric CIRB Application for Continuing Review.
Please submit the completed application and the required supporting documents via email to
either [email protected] or [email protected].

July
2018 Version Dated01/20/11 Update 07/07/17
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