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Pages 141-196

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From page 141... ... An AE can be any unfavorable and unintended sign, symptom, or disease. AFFILIATE'S HUMAN RESEARCH PROTECTION PROGRAM The HRPP of a VAMC's academic affiliate. Read the entire page →
From page 142... ... HUMAN RESEARCH PROTECTION PROGRAM (HRPP) The systematic and comprehensive approach by an organization to ensure human subject protection in all research. Read the entire page →
From page 143... ... The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization's responsibilities for meeting the requirements of 45 CFR 46. MPAs will be replaced by FWAs. Read the entire page →
From page 144... ... UNEXPECTED ADVERSE EVENT Any adverse event that has not previously been observed (e.g., included in the investigator brochure) Read the entire page →
From page 147... ... 147 Cal ._ , Ct C) Read the entire page →
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From page 193... ... 193 o ~ ~ so C) Read the entire page →
From page 195... ... \| Comment Privacy and Conf- Requirement 1.B Should the IRB minutes be included as dentiality Data source/method a possible data source/method for evaluating IRB assessment of provi sions to protect privacy in individual proposals All Data Source/method Is a one-year look-back period an ap propriate timeframe for adequate evaluation of an HRPP? Read the entire page →
From page 196... ... 196 a o au au a au .> au C) Read the entire page →

From page 141...

... An AE can be any unfavorable and unintended sign, symptom, or disease. AFFILIATE'S HUMAN RESEARCH PROTECTION PROGRAM The HRPP of a VAMC's academic affiliate.