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