ICH and OHRP Guidance
ICH (International Conference on Harminization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
- E6_ICH Good Clinical Practice
- E15 FDA Guidance Document
- AAHRPP Tip Sheet 11: Following the Guideline of the ICH -- Good Clinical Practice (E6)
OHRP (Office for Human Research Protections)
- OHRP Guidance on Genetic Information Nondiscrimination Act (GINA)
- Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule) (Formerly Form 310)
- ORHP Guidance on Engagement of Institutions in Human Subjects Research
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