Institutions' Roles With The CIRB

SIGNATORY INSTITUTION

A Signatory Institution:

• Has a direct relationship with the CIRB.
• Signs the Authorization Agreement and the Division of Responsibilities document.
• Has the option of including Affiliate and Component Institutions.
• Is responsible for defining the local context considerations and reporting to the CIRB using the Annual Signatory Institution Worksheet.
• Ensures that all covered entities conform to the local context considerations.

NOTE:  The responsibilities of the Signatory Institution are listed on the Authorization Agreement.

COMPONENT INSTITUTION

A Component Institution:

• Operates under a different name than the Signatory Institution.
• Uses the same Federal-wide Assurance (FWA) number as the Signatory Institution.
• Adheres to the same local context considerations as the Signatory Institution. Uses the same boilerplate language and institutional requirements of the Signatory Institution.
• Conducts research that is monitored by the same office as the Signatory Institution.

NOTE: The Signatory Institution has legal authority over the Component Institution.

AFFILIATE INSTITUTION

An Affiliate Institution:

• Has a direct relationship with the Signatory Institution and its own FWA number.
• Adheres to the same local context considerations of the Signatory Institution.
• Uses the same boilerplate language and institutional requirements of the Signatory Institution.
• Conducts research that is monitored by the same office as the Signatory Institution.

USEFUL TIPS

All institutions where CTEP-sponsored clinical research trials are conducted must have a unique CTEP Site Code.  If you need a CTEP Site Code or have questions, go to the Enterprise Core Unit (ECU) at ecuhelpdesk@mail.nih.gov.