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Research Support Slides

The following links are to slide presentations done by the Office of Research Compliance or one of its affiliates.

Q&A Forums

  •   Human Subject Protection Education

  •   HIPAA and Research

  •   The Informed Consent Process

  •   Electronic Systems Validation 21 CFR 11

  •   The A – Z of INDs (Investigational New Drug Exemptions)

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    RSRA Presentations

  • Record Keeping and Regulatory Binders

  • Writing Standard Operating Procedures

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    Other Program Slides

  • IRB Flexibility (OHRP) for Behavioral Research

  • Oversight of Social and Behavioral Research (OHRP)

  • http://www.fda.gov/cber/summaries/socra051706ph1.pdf

  • http://www.fda.gov/oc/gcp/slideshows/lepay2001/SQAWeb.ppt#257,1,GCP, Quality Assurance, and FDA

  • http://www.fda.gov/cder/present/dia698/diafda2/diafda2.PPT

  • http://www.fda.gov/oc/gcp/slideshows/misconduct2001/misconduct.ppt#256,1,Scientific Misconduct -The “F” word-

  • http://www.fda.gov/cder/present/dia-699/lepay-dia99/lepay-dia99.PPT#256,1,GCP   COMPLIANCE: Emerging Issues in Worldwide Clinical Trials


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