The Annual Action Plan Substantial Amendment - Tarrant County 2025

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Amendments to the trial are regarded as substantial where they are likely to have a significant impact on: the safety or physical or mental integrity of the subjects, or the scientific value of the trial, or the conduct or management of the trial, or the quality or safety of any IMP used in the trial.
substantial amendment is for the HOME-ARP Allocation Plan. A preference permits an eligible QP applicant to be selected for assistance before another eligible qualifying applicant. A limitation excludes certain QPs or subpopulations of QPs from eligibility for a project or activity.
Substantial amendments involve significant changes to the design and methodology of a research project. Non-substantial amendments do not involve significant changes to the design and methodology of a research project.
By definition A substantial amendment is a change that is likely to have a significant impact on the safety or physical or mental integrity of the clinical trial subjects, or the scientific value of the clinical trial [1].
Substantive Amendment means an amendment other than an Editorial Amendment. It changes the purpose, scope or substantive content of the Policy Instrument.
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A substantial modification (SM) is defined as any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 of the CTR and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and

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