'Informed consent requirements' presentation slideshows

FDA Compliance Actions Against IRBs and Clinical Investigators

FDA Compliance Actions Against IRBs and Clinical Investigators. Paul W. Goebel, Jr., CIP Vice President pgoebel@irbinfo.com. Chesapeake Research Review, Inc. 410-884-2900 www.chesapeakeirb.com. Medical Research Summit

579 views • 47 slides

Legally Effective Informed Consent VA Requirements

Legally Effective Informed Consent VA Requirements. Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education (PRIDE). Topics. General requirements Required elements Additional elements FDA element for Clinical Trial Documentation

633 views • 45 slides

375 views • 37 slides

Differences in OHRP, FDA and ICH Regulations/Guidelines

Differences in OHRP, FDA and ICH Regulations/Guidelines. Monika Haugstetter, MHA, MSN, RN Human Subject Protection Office (HSPO) and Institutional Review Board (IRB), UCHC September 2010. Outline . Agencies Applicable Regulations/Guidelines Scope Definition of Research

1.71k views • 24 slides

How would you revise the human subject research regulations?

How would you revise the human subject research regulations?. 4th Annual Medical Research Summit Baltimore, April 22, 2004. Steven Peckman; University of California, Los Angeles With thanks to Dale Hammerschmidt, M.D .; University of Minnesota.

318 views • 19 slides

Informed consent requirements

Informed consent requirements. An IRB Infoshort , June 2013. Informed Consent: Basis. The federally mandated requirements for informed consent are grounded in the Belmont Report. Respect for Persons:

313 views • 9 slides