Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
Title
Policy for CIRB Process for the NCI National Clinical Trials Network (NCTN)
Departmental Policy Number
120
Purpose
The purpose of this policy is to outline roles, responsibilities, and expectations
related to the acceptance, study start-up, maintenance and closure processes of
CIRB NCTN trials.
Definitions/Abbreviations
CAM- CIRB Acknowledgement Memo
CCRRC – Cancer Clinical Research Review Committee
CIRB – NCI’s Central Institutional Review Board
CRMO – Clinical Research Management Office
CTOC – Clinical Trial Oversight Committee
HM – Hematological Malignancies
ICF – Informed Consent Form
IRB – Institutional Review Board
JKCCN – Jefferson Kimmel Cancer Center Network
KCC – Kimmel Cancer Center
MDG – Multi-disciplinary Group
MCSF- Masters Submission Committee Form
NCI –National Cancer Institute
NCTN- National Clinical Trials Network
PI – Principal Investigator
RA – Regulatory Affairs
ROPG – Radiation Oncology Protocol Group
Approved Date:
Effective date:
Version 3.0_ April 16, 2014
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
SOC – Standard of Care
STO – Solid Tumor Oncology
TJU – Thomas Jefferson University
Policy Statement
The Kimmel Cancer Center is an NCI designated cancer center. The NCI
requires that we evolve as a cancer center and make every effort to increase
accrual in our clinical trials targeting cancer. As an NCI designated cancer
center we are mandated to make appropriate clinical trials available to the
community in which we serve. To ensure that our clinical trial portfolio fits our
patient population and their needs, while supporting faculty research interests, a
specific process must be followed to determine that pursuing a clinical trial is
appropriate. This process is a two-fold one in which potential clinical trials are
reviewed and vetted by the relevant MDG and then approved by the Director of
Solid Tumor Oncology or the Director of Hematological Malignancies. As an NCI
designated cancer center we must also ensure that new trials are opened and
activated in a timely manner. To do that a streamlined process has been
developed and implemented for NCI NCTN Trials for which TJU accepts CIRB
review by a “facilitated review” process.
Scope
This SOP describes the processes for the internal management of the CIRB
independent model trials at TJU:

Initiating a new CIRB-approved protocol

Amendments both internal and external (NCTN)

Continuing Reviews

Study closure
This policy is applicable to the following studies:
Approved Date:
Effective date:
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials

CIRB-approved NCTN Trials accepted by the TJU IRB through the
facilitated review process as described in the IRB Authorization
Agreement between TJU and the NCI CIRB.
Responsibility for Executing the Policy
For the departments that conduct cancer research, the Department Chair will
hold the Director of Solid Tumor Oncology and the Director of Hematological
Malignancies responsible for reviewing and approving all new potential cancer
trials for their tumor type prior to MDG review and approval to ensure that the
appropriate clinical trials are being opened and available to our patients. The
Director of Solid Tumor Oncology and the Director of Hematological
Malignancies will also hold the PIs responsible for the timely completion of the
study. The Master Cancer Submission Committee Form (MCSF) will be provided
to the PI by the MDG coordinator or the PIs can also retrieve this form from the
KCC website. The PIs will then need to submit both the MCSF and the approved
MDG protocol to CCRRC@jefferson.edu, for expedited administrative review.
Roles
The following information describes which areas (groups or Individuals) and
associated roles that shall adhere to this policy. A single person may perform
multiple roles.
Department Chair: The Department Chair or designee is responsible to ensure
compliance with all aspects of this policy specifically to ensure that all new
potential trials are being reviewed by the appropriate Director and their decision
to move forward or decline is communicated to the CRMO.
Director of Solid Tumor Oncology and the Director of Hematological
Malignancies: The Director of either Solid Tumor Oncology or Hematological
Malignancies shall be responsible for the review and approval to either move
Approved Date:
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
forward with a new CIRB-approved trial or decline participation for Jefferson as a
site.
MDG Leaders (e.g. Trial Team Leaders or “Champions”): The Trial Team
Leaders shall be assigned by the Director of STO and the Director of HM, and
shall be responsible for the initial review of protocols prior to sending to the
Director of STO or the Director of HM for final approval. If the Trial Team Leader
is interested in pursuing the protocol, s/he shall submit to the MDG coordinator to
place trial on the MDG agenda.
Principal Investigator: The Principal Investigator or designee shall be
responsible for the timely completion of the MCSF and protocol submission to the
CCRRC@jefferson.edu
CRMO: CRMO Associate Director of Regulatory Affairs or designee is
responsible for relaying all new potential trial information to the CRMO or ROPG
in the bi-monthly (protocol development meeting and entering information in to
JeffTrial for CCRRC submission).
Multidisciplinary oncology working groups (MDG): MDGs are responsible for
vetting each trial for feasibility, coordination, data management, and regulatory
resource capability and to ensure that the current docket does not contain open
competing trials. The MDG physician leader will approve the study to move
forward to IRB submission by signing the MCSF.
Procedure
START-UP OF CIRB PROTOCOL
Role
PI,JKCCN
Senior
Step
Activity
Receives notice of CIRB NCTN trial activation by the respective
Sponsor. Sends targeted email to the MDG leader and MDG
Approved Date:
Effective date:
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
Outreach
Coordinator
MDG
Coordinator
PI
Associate
Director of RA
or Designee
1.0
1.1
1.2
coordinator to gauge interest of the trial at TJU. If MDG leadership
confirms interest in the trial, the CRMO/ROPG will manage the trial
(proceed to step 1.0). If MDG leadership declines interest in study
the JKCCN will open trial for the JKCCN affiliates only (proceed
step 1.1) by submitting the MCSF to CCRRC.
Will send an email to CCRRC regarding the New NCTN trial
approval at MDG
Will submit the Protocol and MCSF to ccrrc@jefferson.edu
Upload the information from MCSF and protocol to JeffTrial for
expedited administrative review and assign a CCRRC number.
This timeline will be approximately 3-4 working days
The study title format must read:
** “(CIRB)” before the actual title and end with the NCTN and
number**.
Associate
Director of RA
or Designee
1.3
Delegate the approved CIRB trial to the regulatory coordinator.
•
1.3
Regulatory
Coordinator
Will complete the TJU KCC internal form: CIRB
Acknowledgment Memo (CAM) (APPENDIX I) and send
out for signature to PI, chair and administrator, Complete
CIRB Study-specific worksheet found in the CIRB
Management Site about local context Confirm with JKCCN
to see if any JKCCN affiliates are participating in the trial
•
Regulatory
Coordinator
Merge CIRB ICF (downloaded from CIRB portal) with TJU
approved ICF template language,
• Retrieve the Protocol and MCSF from JeffTrial.
• Signatures have returned, log on to the CIRB website and
download the CIRB approval letter, subject materials if
applicable, and investigator brochure
• Send the merged ICF document and the CIRB consent to
the regulatory supervisor for QA
1.4
•
Regulatory
Supervisor or
designee of
Network (in
network only
trials)
Regulatory
Coordinator
•
•
1.5
QA by comparing the two documents received electronically from
the Regulatory Coordinator and verify all CIRB requirements are
incorporated.
Return email confirmation of approval and consent to the
regulatory coordinator for TJU IRB submission
You may NOT QA and stamp a consent that you merged.
Submission to the local TJU IRB Portal includes :
• CAM only. (The purpose of creating a Portal submission is
Approved Date:
Effective date:
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Policy: CIRB NCTN Trials
twofold: to trigger assignment of IRB control # to study and
to enter study onto an IRB agenda.)
Transaction Submission to JeffTrial:
Under “Review Information”:
Submit Date: date submitted
Review Reason: initial
Under “Details”:
• CAM
• Protocol
• Subject materials (if applicable)
• Consent
• Appropriate JKCCN consent addendums (if applicable)
• IB
• CIRB Acceptance Letter
NO PAPER COPY will be submitted to the TJU IRB
TJU IRB
Personnel
1.6
Receives CAM from TJU IRB electronic submission Portal and
logs into JeffTrial to assign the IRB control number and place it in
the management tab section in a timely manner
TJU IRB
Personnel
1.7
In JeffTrial, under the “Reviews”>> IRB Tab, finds transaction and
completes the following fields:
Review date: date received
Committee: NCI CIRB
Review type: facilitated
Action : acknowledged
Action date: same as review date
e-mail regulatory coordinator that trial was received and
acknowledged
Regulatory
Coordinator
Regulatory
Supervisor or
designee of
network (in
network only
trials)
1.8
No TJU IRB approval letter is issued.
Add the TJU IRB control number to the consent form per header
template and send to the Regulatory Supervisor for stamping of
the consent.
stamp consent and subject materials with :
“CIRB STUDY (do not sign after: expiration date _________)”


Approved Date:
Effective date:
Version 3.0_ April 16, 2014
Expiration consent date is listed on initial CIRB approval letter
and subject materials are to expire at “end of study”
Footer with version number is required
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
Then send back to the Regulatory Coordinator to upload into JeffTrial.
Regulatory
Coordinator
or designee
1.9
Upload Transaction Submission documents to JeffTrial:
•
•
•
•
•
•
•
CTSU
2.0
CAM
Protocol
Stamped Subject materials (if applicable)
Stamped consent
Stamped JKCCN consent addendum (if applicable)
IB- these must be downloaded from the appropriate
sponsor site or CTSU
CIRB Acceptance letter
CTSU will be copied on the NCI CIRB initial approval email. CTSU
will email requesting confirmation of all site codes participating.
Note: (This is all that needs to be done for new CIRB studies in terms of
CTSU).
Regulatory
Coordinator
or designee
2.1
Regulatory coordinator will respond via email to CTSU with TJU
site code and any participating network site codes.
Regulatory
Coordinator
or designee
2.2
Follow internal CRMO red folder process email
Clinical
Coordinator
2.3
Activates trial as per CRMO, ROPG or JKCCN standard practice
Continuing Reviews
Regulatory
Coordinator
3.0
When due at 4 weeks out from CIRB expiration
•
•
•
login CIRB website and
download the CR approval,
stamp current Merged consent
“CIRB STUDY (do not sign after: expiration date _________)”


Expiration consent date is listed on current CIRB approval letter
Footer with version number is required
Note: the CIRB perspective on CRs - local sites have no regulatory
responsibility and this strictly a TJU process
Approved Date:
Effective date:
Version 3.0_ April 16, 2014
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
Regulatory
Coordinator
3.1
Regulatory
Coordinator
or designee
3.2
Regulatory
Coordinator
or designee
3.3
Upload Transaction Submission to JeffTrial:
Under “Review Information”:
Review date: date submitted
Submit date: date submitted
Committee: NCI CIRB
Review reason: Continuing Review
Review type: Facilitated
Action : acknowledged
Action date: same date as submit date
Expiration date: According to CIRB approval letter
Under “Details”:
• Stamped consent (for open to accrual only)
• Stamped JKCCN consent addendum (for open to accrual
only)
• CIRB Continuing Review Approval letter
Note that CR will NOT be uploaded to the Portal
Follow internal CRMO red folder process email and file accordingly
Complete and Fax CTSU the ‘Acknowledgment Form (for sites
utilizing the NCI CIRB)’
Amendments (Internal)
Regulatory
Coordinator
4.0
Receives amendment via clinical coordinator or P.I.
Examples of internal amendments include: adding or removing
staff, adding a JKCCN site, increasing accrual, foreign language
consents etc)
**Note: Closing accrual doesn’t change the consent or the memo
therefore only emailing notification to Regulatory Registration
Compliance Manager to update JeffTrial is required. Print out the
email and file it accordingly.
Regulatory
Coordinator
4.1
*** Note: if PI changes all parties need notification ( TJU IRB,
CIRB, CTSU) proceed to step 5.0
Necessary changes are made to the consent form or CIRB
Acknowledgement Memo ( CO-I change, staff list etc)
Need to be sent out for signature and re-stamp consent (updating
the ‘TJU version’ date in the footer)
Email the Senior Outreach Coordinator at the Network all staff
member changes.
Approved Date:
Effective date:
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
Note: 12B/Cs are not used in this process
“CIRB STUDY (do not sign after: expiration date _________)”


Senior
Outreach
Coordinator
Expiration consent date is listed on current CIRB approval letter
Footer with version number is required
Responsible for maintaining the CIRB rosters for TJU and its
affiliates.
Regulatory
Coordinator
or designee
4.2
Upload changed documents and release in JeffTrial.
Upload Transaction Submission to JeffTrials::
Under Review Information:
Review date: date submitted
Submit date: date submitted
Committee: NCI CIRB
Review reason: Amendment
Review type: Facilitated
Action : acknowledged
Action date: same date as submit date
Under Details:
• Stamped consent (if applicable)
• Stamped JKCCN consent addendum (if applicable)
Updated CIRB Acknowledgement Memo
Note that these Amendments will NOT be uploaded to the Portal
Regulatory
Coordinator
or designee
4.3
Follow internal CRMO red folder process email and file accordingly
Amendments (External)
Regulatory
Coordinator
5.0
Receives amendment via email from applicable NCTN,
**Note: this includes PI Changes**
Regulatory
Coordinator
5.1
Log into CIRB website and download all amendment materials
Regulatory
Coordinator
5.1
Necessary changes are made to the consent form, updating the
footer to read the new protocol version date, and
re-stamp consent.
“CIRB STUDY (do not sign after: expiration date _________)”
Approved Date:
Effective date:
Version 3.0_ April 16, 2014
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials


Regulatory
Coordinator
or designee
5.2
Expiration consent date is listed on current CIRB approval letter
and subject materials are to expire at “end of study”
Footer with version number is required
Upload Transaction Submission to JeffTrials:
Under “Review Information”:
Review date: date submitted
Submit date: date submitted
Committee: NCI CIRB
Review reason: Amendment
Review type: Facilitated
Action : acknowledged
Action date: same date as submit date
Under “Details”:
•
•
•
•
•
•
Protocol --only if changed
Summary of Changes
Stamped Subject materials --only if changed
Stamped Consent-- only if changed
IB- -only if changed
CIRB Amendment Approval letter
Note that these amendments will NOT be uploaded to the Portal
Regulatory
Coordinator
or designee
5.3
Complete and Fax CTSU the ‘Acknowledgment Form (for sites
utilizing the NCI CIRB)’
Final Closure
Regulatory
Coordinator
6.0
Receives closure notification via email from applicable NCTN
Group
Regulatory
Coordinator
6.1
Log into CIRB website and download all closure materials
Regulatory
Coordinator
or designee
6.2
Upload Transaction Submission to JeffTrials:
Under “Review Information”:
Review date: date submitted
Submit date: date submitted
Committee: NCI CIRB
Review reason: Final
Review type: Facilitated
Approved Date:
Effective date:
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Clinical Research Management Office - Kimmel Cancer Center
Policy 120
Policy: CIRB NCTN Trials
Action : acknowledged
Action date: same date as submit date
Under “Details”:
• CIRB Final Closure Approval letter
Note that Final Reports are NOT uploaded to the Portal
Regulatory
Coordinator
or designee
6.3
Complete and Fax CTSU the ‘Acknowledgment Form (for sites
utilizing the NCI CIRB)’
Approved By:
Endorsed by:
TJU IRB: Jackson Bruce Smith, MD, CIP –Director, Office of Human Research ,
Thomas Jefferson University
KCC CRMO: Sylvia O’Neill, MD- Associate Director of Regulatory Affairs and QA
Natalie Schultz, BA- Regulatory Coordinator
JKCCN: Joshua Schoppe, MPH, CCRP, Senior Outreach Coordinator for Research,
ECOG/CTSU Administrator
Appendix I: CIRB Acknowledgement Memo:
CIRB Trial Acknowledgement Memo (CAM)
Date of Notification:
Protocol Title:
PI:
JeffTrial Number:
IRB Control Number:
CCRRC number:
Approved Date:
Effective date:
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Policy 120
Policy: CIRB NCTN Trials
ITEMS REQUESTED:
Network participation: Yes
or
 No
 Only
Staff members list included (staff signatures not needed) 
Communication to TJU IRB will be limited to: Initial study acknowledgement, any
modifications to CIRB Trial Notification Memo, and suspensions due to safety issues
Serious Adverse events will only be reported per the NCTN specific protocol and the
CIRB SOP reporting guidelines. Unanticipated problems and potential
noncompliance will be reported to both the TJU IRB (OHR-20) and the CIRB via the
appropriate established mechanisms.
The Signatory Institution must provide independent oversight of the conduct of the
research. The TJU IRB reserves the right to conduct audits or interim trial reviews as
needed. In the latter case, the OHR-9 will be used.
Signatures
_______________________________________________Date______________________
PI signature
____________________________________________Date____________________
Chairman
_______________________________________________Date______________________
Regulatory Coordinator
Appendix II: CIRB Transmittal form
Approved Date:
Effective date:
Version 3.0_ April 16, 2014
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