Form 19 NCI CIRB Signatory Enrollment Form

Section A: Signatory Institution Information

OMB #0925-xxxx
Expiration Date: xx/xx/xxxx

NCI CIRB SIGNATORY INSTITUTION ENROLLMENT FORM
The NCI CIRB Signatory Institution Enrollment Form is a Microsoft Word document that must be completed electronically.
Once the Form is completed, save it as a Word document, and then email it to the CIRB Operations Office at
[email protected].

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SECTION A: SIGNATORY INSTITUTION INFORMATION ....................................................................................... 2

•

SECTION B: COMPONENT INSTITUTIONS AS DEFINED BY THE CIRB .............................................................. 3

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SECTION C: SIGNATORY INSTITUTION PRINCIPAL INVESTIGATOR INFORMATION ................................ 5

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SECTION D: AFFILIATE INSTITUTIONS AS DEFINED BY THE CIRB .............................................................. 111

OMB#: 0925 – xxxx

Expiry Date: xx/xx/xxxx

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the
NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing
from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected will be kept private
to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined
for all participants and reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with
the operations of NCI CIRB Initiative.
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 (0925-0046-16). Do not return the completed form to this address.

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Section A: Signatory Institution Information
Section A: Signatory Institution Information
(Institution of Signatory Official who signs the Authorization Agreement)
Signatory Institution Name
Street Address
Street Address #2
City

State

OHRP Federalwide Assurance (FWA) Number

Zip
CTEP Site Code

Identify the Signatory Official at the Signatory Institution
First Name

Last Name

Role

Email Address

Telephone Number (

)

-

Degree

Extension

Research Oversight
Does the Signatory Institution operate an internal IRB? (Yes, No)

Institution GUID (Internal Use Only)

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Section B: Component Institutions as Defined by the CIRB
Section B: Component Institutions as Defined by the CIRB
Component Institutions are defined by the CIRB as meeting ALL of the following criteria:
• the Component Institution operates under a different name than the Signatory Institution, but the Signatory
Institution has legal authority for the Component Institution;
• the FWA number for the Component Institution is the same as the Signatory Institution;
• the local context considerations of the Component Institution are the same as the Signatory Institution. Local
context considerations are reported by the Signatory Institution in the Annual Institution Worksheet About Local
Context;
• the boilerplate language and institutional requirements of the Component Institution are the same as the
Signatory Institution. The boilerplate language and institutional requirements are reported by the Signatory
Institution in the Annual Institution Worksheet About Local Context; and
• the conduct of research at the Component Institution is monitored by the same office as the Signatory Institution.
List all Component Institutions that meet the CIRB’s definition. All institutions where NCI CTEP-sponsored clinical
research trials are conducted must have a CTEP Site Code. Questions or request for assignment of a CTEP Site Code
should be direct to the ECU at [email protected]
NOTE: Information about Affiliate Institutions is captured in Section D.
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City

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CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip

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Section B: Component Institutions as Defined by the CIRB

Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City
Component Institution Information
Institution Name
Street Address
Street Address #2
City

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CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip
CTEP Site Code

State

Zip

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Section C: Staff Requiring Access to IRBManager

Section C: Staff Requiring Access to IRBManager
Provide contact information for investigators and research staff who require access to IRBManager.
Role Definitions:
• Signatory Primary Contact Person – individuals who will serve as the primary point of contact for NCI CIRB related
issues at the Signatory Institution.
• Signatory Institution Principal Investigators (PIs) - Investigators who have the authority to open studies under the
authority of the Signatory Institution and conform to the Authorization Agreement/Division of Responsibilities with
the NCI CIRB.
• Research Staff – individuals who need access to the IRBManager to complete the various required worksheets on
behalf of the Signatory Institution or Signatory Institution Principal Investigators.
All persons listed below must have an active CTEP Person ID. To register or update information with the Cancer Therapy
Evaluation Program - Identity and Access Management (CTEP-IAM) follow the directions at
https://www.ctsu.org/Public/RegProced_ir-ar.aspx.
Sub-Investigators and other support staff not listed below will still have access to the NCI CIRB website and CTSU website
through their associations on the Network Group rosters.
Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

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CTEP Person ID
Principal Investigator

Research Staff

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Section C: Staff Requiring Access to IRBManager
Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

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CTEP Person ID
Principal Investigator

Research Staff

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Section C: Staff Requiring Access to IRBManager
Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

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CTEP Person ID
Principal Investigator

Research Staff

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Section C: Staff Requiring Access to IRBManager
Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

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CTEP Person ID
Principal Investigator

Research Staff

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Section C: Staff Requiring Access to IRBManager
Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

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CTEP Person ID
Principal Investigator

Research Staff

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Section C: Staff Requiring Access to IRBManager
Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

Person Information
First Name
Role

Last Name
Signatory Primary Contact Person

CTEP Person ID
Principal Investigator

Research Staff

If you need to add more staff who require access to IRBManager to assist with completing the required worksheets, access
the form located at the following URL https://www.ncicirb.org/Personnel_SignatoryInstitution.doc. Complete the form, save
it as a Word document, and email it with your completed Enrollment Form to the CIRB Operations Office at
[email protected].
Click here to move to the next section.

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Section D: Affiliate Institutions as Defined by the CIRB
Section D: Affiliate Institutions as Defined by the CIRB
Affiliate Institutions are defined by the CIRB as meeting ALL of the following criteria:
• The local context considerations of the Affiliate Institution are the same as the Signatory Institution. Local
context considerations are reported by the Signatory Institution in the Annual Institution Worksheet About Local
Context;
• The boilerplate language and institutional requirements of the Affiliate Institution are the same as the Signatory
Institution. The boilerplate language and institutional requirements are reported by the Signatory Institution in
the Annual Institution Worksheet About Local Context; and
• The conduct of research at the Affiliate Institution is monitored by the same office as the Signatory Institution.
List each Affiliate Institution that meets the CIRB’s definition. All institutions where NCI CTEP-sponsored clinical research
trials are conducted must have a CTEP Site Code. Questions or request for assignment of a CTEP Site Code should be
direct to the ECU at [email protected]
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number

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Section D: Affiliate Institutions as Defined by the CIRB (continued)
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
Affiliate Institution Information
Institution Name

CTEP Site Code

FWA Number
If you need to add more Affiliate Institutions, access the form located at the following URL
https://www.ncicirb.org/Institution_Affiliate.doc. Complete the form, save it as a Word document, and email it with your
completed Enrollment Form to the CIRB Operations Office at [email protected].
If there are no other Affiliate Institutions, you have completed this form. Please review and return the completed worksheet to
the CIRB Operations Office via email to [email protected]. Thank you.
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