Cancer Protocol Committee (CPC) - New Protocol Submission Form
Form is required for all cancer-related protocols. Form must be uploaded into Section 15.2 CPC Application in eIRB.
eIRB #: Pro
Full Protocol Title:
Principal Investigator:
Date:
SECTION 1: PI SIGNATURE AND ACKNOWLEDGEMENT
With my signature, I, the Principal Investigator, confirm that:
1. The information in all pages of this submission form is true and accurate to the best of my knowledge.
2. All key personnel who are listed in eIRB have:
a. Been made aware that they are listed as key personnel on this protocol.
b. Had a chance to review the protocol.
c. Had sufficient time to provide feedback on the feasibility, scientific merit, and benefits/drawbacks of the protocol.
3. For DCI PI-initiated protocols or protocols in which the DCI is the lead/coordinating site, data analyses will not be shared in
any public forum without first consulting with the DCI-approved statistician who is listed as key personnel in this study.
4. The Projected Accrual in this Form was agreed upon by me and the appropriate Disease Group Leader (see Appendix B).
5. The Protocol Priority in this Form was agreed upon by the appropriate Disease Group Leader (see Appendix B).
6. All study activities will be conducted in accordance with the protocol.
Signature
Date
Acceptable forms of PI Signature and Acknowledgement
1. Signature and date on this document
2. Email confirmation, which meets the following requirements:
- Subject line of email must contain eIRB number
- PI’s email must contain study title, PI Signature and Acknowledgement above, and short “I confirm” statement
- PDF of PI’s email must be uploaded into Section 15.2 of eIRB along with the New Protocol Submission Form
NPS form, version 06.27.14
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SECTION 2: PROTOCOL SUBMISSION CHECKLIST
A. If this is a Duke PI-initiated protocol, provide the name of the DCI-approved Statistician who helped develop
the statistical analysis plan.
(add Statistician to key personnel in eIRB)
If this is an externally-initiated protocol, provide the name of the DCI-approved Statistician who provided
feedback on the protocol design and statistical analysis plan.
B. Will Investigational Chemotherapy Services (ICS) manage an investigational agent in this protocol?
If yes, the protocol must be emailed to ICS at invchsvc@notes.duke.edu.
If no, please specify who will manage the investigational agent:
Yes
No
C.
Yes
No
Yes
No
Check yes to confirm that the signed/approved Pathology Review Form been uploaded into Section 7 in eIRB
Yes
N/A
E.
Will this protocol use the DCI Safety Surveillance Team to assist in adverse event tracking and reporting?
If yes, email dcccsafety@duke.edu with the subject header “DCI Safety Team Needed for Pro########”.
Yes
No
F.
Will this protocol require the services of the DCI-IT team to help develop a study database?
Yes
No
G. Is funding for this protocol supported by or expected to be supported by a grant?
If yes, please answer the following:
1. Has the NIH, NCI, DOD, Komen, or other source approved the funding?
2. Has documentation of approved funding been uploaded in Section 4 of the eIRB submission?
i. If no, has a grant score been released or is funding pending?
ii. If yes, please confirm upload of documentation to Section 4 of the eIRB submission
3. Confirm that the full grant submission been uploaded in Section 4 of the eIRB submission?
4. Does this protocol represent a “just-in-time” submission?
Yes
No
H. Is this protocol being conducted as part of a project required for graduation (i.e. Masters or PhD degree)?
Yes
No
I.
Yes
No
Does this protocol involve research-related CT, MRI, PET, Ultrasound, or SPECT imaging?
If yes and the protocol requires the services of the Dept. of Radiology, complete the Radiology Clinical Trial
Imaging Form to Request Radiology Review located here, and email this form, the protocol, and imaging
manual (if available) to steven.shipes@dm.duke.edu.
D. Does this protocol involve research-related human tissue collection (biopsies, resection, or excess tissues)?
If yes, complete the Pathology Review Form located here, and email this form, the research summary, and
protocol to Tom Dod (dod00001@mc.duke.edu) and Rex Bentley (bentl003@mc.duke.edu).
Does this study involve a consent form?
If no, this form is complete.
If yes: complete remainder of this form.
Yes
No
Yes
No
Yes
No
Confirmed
Confirmed
Yes
No
1. Does the study involve a drug or device intervention?
 If yes, name the Research Nurse who reviewed this protocol for feasibility:
 If no, name the appropriate key personnel who reviewed the protocol for feasibility:
 Please supply the estimated primary completion date:
The primary completion date is defined as the date that the final subject was examined or received an intervention
for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according
to the prespecified protocol or was terminated.
 Please supply the estimated study completion date:
The study completion date is defined as the final date on which data was (or is expected to be) collected.
NPS form, version 06.27.14
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SECTION 3: PROTOCOL PRIORITIZATION
Select a Protocol Priority
Rate of accrual expected by CPC**
High
75% of projected cumulative accrual
CPC-IRB FastLane request?*
yes
no
Standard
75% of projected cumulative accrual
*The CPC-IRB FastLane is collaboration between the CPC and IRB that seeks to accelerate the review process for high priority
protocols only. Since the FastLane requires extensive coordination between the CPC, IRB, PI, and study team, the CPC should be
notified (beth.maynard@duke.edu) about the intent to select the FastLane option as early as possible prior to PI sign-off in eIRB.
The reason for the request must be submitted with the request and the disease group leader must confirm the commitment of the
study team and the disease group to the protocol’s priority. The ability to do a FastLane review will depend on the availability of
CPC/IRB personnel and CPC/IRB meeting dates. It is expected that the study team has informed all organizations responsible for
reviewing the study the nature of the FastLane process. The CPC will follow the study until institutional approval is granted to ensure
the process is moving as expected.
** For protocols involving very low projected annual accrual or rare cancer subjects, exceptions to accrual benchmarks and
consequences may be allowed on a case-by case basis.
SECTION 4: ENROLLMENT SITES
Check the enrollment sites for which the protocol is currently seeking approval.
Duke University Medical Center (DUMC)
Duke Raleigh
Duke Regional
Duke Cancer Network
Other, please specify:
SECTION 5: PROJECTED ACCRUAL
Projected accrual should be based on PI input, Disease Group Leader input, protocol priority, and availability of the subject
population. Future CPC decisions on renewal or termination will be based primarily on accrual projections provided below.
Max # of subjects to be consented at DUMC
Time from IRB Initial Review Date
Projected # of subjects who are not screen failures
At DUMC
Yr 1
Yr 2
Yr 3
Yr 4
Yr 5
Yr 6
Yr 7
Yr 8+
Total
At non-DUMC sites:
(Complete this row only if protocol is
Duke PI-initiated and multi-site)
Complete projected accrual as thought the study would receive Institutional Approval on the IRB initial review date. The CPC will
adjust its evaluation of accrual to account for time between the IRB Initial Review Date and Institutional Approval.
SECTION 6: COMPETING STUDIES
List all studies that compete for the subject population being recruited for this study.
eIRB #
PI
NPS form, version 06.27.14
Protocol Title
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APPENDIX B: Authorized signatories for each Disease Group
Please follow the link below to find the appropriate Disease Group Leader and Research Group Statistician.
Research Group Signatories
NPS form, version 06.27.14
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