Common use of Institution Providing IRB Review (CDC IRB) Clause in Contracts

Institution Providing IRB Review (CDC IRB). Centers for Disease Control and Prevention (CDC) IRB Registration #: 00002724 Federalwide Assurance (FWA) #: FWA00001413 Name of Relying Institution: IRB Registration #: IRB Registration Expiration Date: The officials signing below agree that may rely on the CDC IRB for review under 21 CFR parts 50, 56 and 312 and for continuing oversight, where applicable, of the involvement of human subjects as described below: Title of IND: Reference ID: Principal/Site Investigator: (name, phone, e-mail) IRB Office Contact: (name, phone, e-mail) Award number, if any: The review and oversight performed by the CDC IRB will meet the human subjects protection and IRB requirements of the FDA regulations cited above, as applicable. The Relying Institution remains responsible for ensuring compliance with the CDC IRB’s determinations and with the terms of its own IRB registration as applicable. This agreement must be kept on file at both institutions and must be provided to FDA upon request. This agreement becomes fully executed upon signatures of the relevant institution's signatory official or designee and remains in effect for as long as the review of the protocol by the reviewing IRB is required or until terminated under the following circumstances: ⁃ Both parties mutually agree to terminate. ⁃ Either party terminates its participation under this agreement; any such unilateral termination must be communicated by the terminating party to the other party thirty (30) business days prior to the effective date of termination. ⁃ The CDC IRB or Relying Institution's IRB registration is suspended, restricted, terminated, or expires; any such suspension, restriction, termination or expiration must be communicated between parties promptly and no later than 2 business days from occurrence.

Institution Providing IRB Review (CDC IRB). Centers for Disease Control and Prevention (CDC) IRB Registration #: 00002724 Federalwide Assurance (FWA) #: FWA00001413 Name of Relying Institution: IRB Registration #: IRB Registration Expiration Date: The officials signing below agree that may rely on the CDC IRB for review under 21 CFR parts 50, 56 and 312 and for continuing oversight, where applicable, of the involvement of human subjects as in the Expanded Access Investigational New Drug (IND) described below: Title of IND: Reference ID: SAMPLE Principal/Site Investigator: (name, phone, e-mail) IRB Office Contact: (name, phone, e-mail) Award number, if any: The review and oversight performed by the CDC IRB will meet the human subjects protection and IRB requirements of the FDA regulations cited above, as applicable. The Relying Institution remains responsible for ensuring compliance with the CDC IRB’s determinations and with the terms of its own IRB registration as applicable. This agreement must be kept on file at both institutions consistent with recordkeeping requirements set out herein and must be provided to FDA upon request. This agreement becomes fully executed upon signatures of the relevant institution's signatory official or designee and remains in effect for as long as the review of the protocol Expanded Access IND by the reviewing CDC IRB is required or until terminated under the following circumstances: ⁃ Both parties mutually agree to terminate. ⁃ Either party terminates its participation under this agreement; any such unilateral termination must be communicated by the terminating party to the other party thirty (30) business days prior to the effective date of termination. ⁃ The CDC IRB or Relying Institution's IRB registration is suspended, restricted, terminated, or expires; any such suspension, restriction, termination or expiration must be communicated between parties promptly and no later than 2 business days from occurrence.

Institution Providing IRB Review (CDC IRB). Centers for Disease Control and Prevention (CDC) Registration expiration date: 12/17/2024 IRB Registration #: 00002724 FWA expiration date: 12/02/2026 Federalwide Assurance (FWA) #: FWA00001413 Name of Relying Institution: IRB Registration #: IRB Registration Expiration Date: The officials signing below agree that SAMPLE may rely on the CDC IRB for review under 21 CFR parts 50, 56 and 312 and for continuing oversight, where applicable, of the involvement of human subjects as in the Expanded Access Investigational New Drug (IND) described below: Title of IND: Reference ID: Principal/Site Investigator: (name, phone, e-mail) IRB Office Contact: (name, phone, e-mail) Sponsor: Award number, if any: The review and oversight performed by the CDC IRB will meet the human subjects protection and IRB requirements of the FDA regulations cited above, as applicable. The Relying Institution remains responsible for ensuring compliance with the CDC IRB’s determinations and with the terms of its own IRB registration as applicable. This agreement must be kept on file at both institutions consistent with recordkeeping requirements set out herein and must be provided to FDA upon request. This agreement becomes fully executed upon signatures of the relevant institution's signatory official or designee and remains in effect for as long as the review of the protocol Expanded Access IND by the reviewing CDC IRB is required or until terminated under the following circumstances: ⁃ • Both parties mutually agree to terminate. ⁃ • Either party terminates its participation under this agreement; any such unilateral termination must be communicated by the terminating party to the other party thirty (30) business days prior to the effective date of termination. ⁃ • The CDC IRB or Relying Institution's IRB registration is suspended, restricted, terminated, or expires; any such suspension, restriction, termination or expiration must be communicated between parties promptly and no later than 2 business days from occurrence.