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    How to get your PI more involved in the clinical Research process

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    Website http://www.globalcompliancetrainings.com/index.php?route=product/product&product_id=7 | Want to Edit it Edit Freely

    Category Online Regulatory Compliance Training, Compliance Training, regulatory compliance training, Online compliance Training, e-learning, Regulatory standards Guidelines, Best Practices, Regulatory Compliance, Compliance Management

    Deadline: October 21, 2013 | Date: October 22, 2013

    Venue/Country: michigan, U.S.A

    Updated: 2013-10-09 21:16:33 (GMT+9)

    Call For Papers - CFP

    When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”. Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards), and 21 CFR 312 (Investigational New Drug Application / IND). For Device studies, 21 CFR 812 (Investigational Device Exemptions / IDE) is added in place of 21 CFR 312. Additional responsibilities are clearly outlined in The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and not follow these regulations is folly

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.