Exemption Determinations definition

Exemption Determinations. Determinations that Research is exempt from IRB review pursuant to the Federal Policy. FDA: The United States Food and Drug Administration.
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Exemption Determinations. A determination by a Reviewing IRB or Reviewing IRB Institution whether Research is exempt from some or all of the requirements of the Federal Policy. FDA: U.S. Food and Drug Administration. FDA Clinical Investigation Regulations: 21 CFR Parts 50, 56, 312, and 812.
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Examples of Exemption Determinations in a sentence

  • All written comments and request for a hearing (at least three copies) should be sent to the Pension and Welfare Benefits Administration, Office of Exemption Determinations, Room N–5649, U.S. Department of Labor, ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇., ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇.

  • A Reviewing IRB/Reviewing IRB Institution will make available to the Relying Institution(s), when applicable and upon request, the Reviewing IRB’s policies and procedures relevant to its review and oversight of Research, and the Reviewing IRB/Reviewing IRB Institution’s policies and procedures regarding Exemption Determinations.

  • In the case of Exemption Determinations, including those for which Limited IRB Review (defined in Exhibit A) is required, and with respect to Research that is subject to an Exemption Determination, all of the terms of this Agreement shall apply to the extent provided therein except for Sections 2.5, 5.4.1, 5.7, 5.9, 5.15, 6.4, 6.8, 6.9, 6.12, and 6.14.

  • I understand that only authorised members or guests may access the Club and I am not permitted to share my Access Card / Access Device with anyone else.

  • All written comments and request for a hearing (at least three copies) should be sent to the Pension and Welfare Benefits Administration, Office of Exemption Determinations, Room N–5649, U.S. Department of Labor, ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇.

  • This exemption is in Director, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor.

  • Director of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor.

Related to Exemption Determinations

  • Self-Determination means a philosophy and process by which individuals with developmental disabilities are empowered to gain control over the selection of support services that meet their needs. The basic principles of self-determination are:

  • Expert Determination the process described in Paragraph 6 of Schedule 8.3 (Dispute Resolution Procedure);

  • Initial determination means the first child custody determination concerning a particular child.

  • SOFR Determination Date has the meaning specified in the definition of “Daily Simple SOFR”.

  • Claim Determination Period means a calendar year. However, it does not include any part of a year during which a person has no coverage under This Plan, or any part of a year before the date this COB provision or a similar provision takes effect.