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Clinical research / Pharmacology / Drug safety / Pharmaceutical industry / Adverse event / Institutional review board / Food and Drug Administration / National Institutes of Health / Adverse effect / Medicine / Health / Research


SOP 16. REPORTING REQUIREMENTS FOR UNANTICIPATED PROBLEMS,
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Document Date: 2014-03-10 08:07:42


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File Size: 1,09 MB

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Company

UPS / AES / /

IndustryTerm

human food additive / biological product / electronic product / /

MedicalCondition

bronchospasm / drug abuse / disease / congenital anomaly/birth defect / /

Organization

NIH OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS / FDA / National Institute of Health / office of Human Research Protections / NIH HRPP / Institutional Review Board / FOOD AND DRUG ADMINISTRATION / AEs NIH / OFFICE FOR HUMAN RESEARCH PROTECTIONS / DHHS office of Human Research Protections / NIH HRPP SOP / HRPP SOP / /

Position

investigator / H. Sponsor-investigator / CLINICAL DIRECTOR / INSTITUTE CLINICAL DIRECTOR / General / Sponsor-investigator / THE CLINICAL DIRECTOR / /

ProvinceOrState

Indiana / /

Technology

IRB-approved research protocol / EXAMPLES OF PROTOCOL / IRBapproved research protocol / 8.4 NIH PROTOCOLS / term Protocol / /

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