Internet Resources
REGULATIONS AND GUIDANCE THAT APPLY TO RESEARCH INVOLVING HUMAN SUBJECTS
| ICH/GCP Regulations |
| ICH GCP E6(R1) Guidelines |
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45 CFR 46 - Federal Policy for the Protection of Human Subjects. The Common Rule (DHHS) |
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Human Subject Regulations Decision Charts, (DHHS) (9/04) http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm |
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21 CFR 50 - Protection of Human Subjects, (FDA) |
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21 CFR 56 - Institutional Review Boards, (FDA) |
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21 CFR 312 - Investigational New Drug Applications, (FDA) http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm |
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21 CFR 812 - Investigational Device Exemptions, (FDA) |
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Office for Human Research Protections (OHRP) |
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Office for Human Research Protections (OHRP) - Frequently asked Questions |
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Clinical Trials and Insurance Coverage - A Resource Guide |
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FDA Guidance |
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Certificates of Confidentiality |


