24 Adult/Pediatric CIRB Application for Continuing Review

Attachment 5E:

NCI ADULT/PEDIATRIC CIRB APPLICATION
FOR
CONTINUING REVIEW

OMB#: 0925 – xxxx Expiry Date: xx/xx/xxxx
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. Completion of this form is required as
per the NCI CIRB Standard Operations Procedures based on 45 CFR 46.103 (b) (4). If you choose not to
complete this form, you will not be able to participate in the CIRB. Data collected as part of the NCI CIRB
review is private and protected by law. Under the provisions of Section 301d of the Public Health Service
Act, no information that could permit identification of a participating individual may be released. All such
information will be kept private under the Privacy Act and will be presented only in statistical or summary
form.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 1 hour 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-xxxx*). Do not return the completed form to this address.
Application Version dated 03/17/10

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NCI ADULT/PEDIATRIC CIRB APPLICATION
FOR
CONTINUING REVIEW

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 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:
Institution:
Address:
Phone Number:
E- mail Address:
FAX Number:

CONTACT PERSON (Person to contact about this application if Chair not available)
Name:
Title:
Institution:
Address:
Phone Number:
E- mail Address:
FAX Number:

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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 Cooperative 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 has yet to be
activated by the Cooperative Group.

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

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:
(CIRB Study Status options continued on next page)

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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
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:

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
b. All participants have completed study intervention.
Yes
c. All participants have completed all follow-up activities.
Yes
d. Analysis of the data is complete.
Yes
e. The study has met its primary objectives and a final study
report/publication has been submitted.
Yes
If Yes, provide a copy of the final report/publication.

No
No
No
No
No

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
c. All follow- up activities have ceased.
Yes
d. No further activity or data analyses are being performed.
Yes

No
No
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.

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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
Native Hawaiian or Other
Pacific Islander
Black or African American
White
Racial Categories: Total of
all Subjects

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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.
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
Native Hawaiian or Other Pacific Islander
Black or African American
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
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or not reported
Racial Categories: Total of Hispanics or
Latinos**
*These totals must agree.

Application Version dated 03/17/10

**These totals must agree.

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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

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 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, 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?
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:

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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 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.

4.1.2

4.2

Date/approximate date of the next DSMB or safety monitoring meeting:

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.

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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.
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.

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].

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)
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)

Application Version dated 03/17/10

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