Protecting Study Volunteers in Research: A Manual for Investigative Sites
Recommended by the National Institutes of Health, the Office of Health and Human Services and the FDA, Protecting Study Volunteers in Research is a 250-page manual designed to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their study volunteers. This convenient and portable manual has become required reading in academic institutions, IRBs and independent investigative sites. Many sponsor and CRO companies have also made this manual mandatory reading for their staff and service providers. Developed in accordance with the essentials and standards of the ACCME, readers can apply for CME credits or Nursing Credit Hours. An exam is provided with each manual. pics include... Historical perspectives on human subject research; Ethics and federal regulations; Roles and responsibilities of institutions and independent sites; Roles and responsibilities of investigators and study staff.
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The Roles and Responsibilities of Institutions in Human Subject Research
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accordance with Sec additional adequate adverse experience Agency head amended at 52 appropriate Assurance Belmont Report biological product Biologics Evaluation biomedical Budget under control Center for Biologics chapter clinical hold clinical investigation Clinical Research clinical trial compliance comply conducted consent form contract research organization control number Declaration of Helsinki Department or Agency determine DHHS document Drug Administration drug application ensure ethical Evaluation and Research exempt federal regulations fetus Food and Drug Health individual information requirements approved informed consent Institutional Review Board investigational device Investigational Device Exemption investigational drug investigational new drug investigational plan investigator's involving human subjects IRB approval IRB review IRB's June 17 licensed manufacturer life-threatening marketing application monitoring notify Nuremberg Code obtained paragraph participation patients person Phase procedures proposed protection records request research subjects responsible safety scientific scientific misconduct submission subpart termination test article tigator tion treatment IND