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FDA website:
http://www.fda.gov |
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Guidance Documents:
www.fda.gov/CDER/guidance/index.htm |
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Good Clinical Practices in FDA-regulated clinical trials:
http://www.fda.gov/oc/gcp/ |
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Comparison of FDA and HHS Human Subject Protections:
http://www.fda.gov/oc/gcp/comparison.html |
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Title 21 Code of Federal Regulations (21 CFR Part 11):
www.fda.gov/ora/compliance_ref/part11/Default.htm |
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Computerized Systems Used in Clinical Trials:
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm |
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Guidance for Industry. Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators:
http://www.fda.gov/cber/gdlns/studysub.pdf |
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Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance:
http://www.fda.gov/cder/guidance/959fnl.pdf |
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Guidance for Industry. Cancer Drug and Biological Products - Clinical Data in Marketing Applications:
http://www.fda.gov/cder/guidance/4332fnl.htm |
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CBER Guidances / Guidelines / Points to Consider:
www.fda.gov/cber/guidelines.htm |
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Electronic Regulatory Submissions and Review:
www.fda.gov/cder/regulatory/ersr |
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Clinical Data Standards:
www.cdisc.org |
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HIPAA:
http://privacyruleandresearch.nih.gov/ |
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Office for Human Research Protections:
http://www.hhs.gov/ohrp/ |
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ICH Guidelines:
http://www.ich.org/cache/compo/276-254-1.html |
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Cancer Therapy Evaluation home Page:
http://ctep.cancer.gov/ |
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Cancer Data Standards Repository:
http://ncicb.nci.nih.gov/NCICB/infrastructure/cacore_overview/cadsr/ |
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NCI:
http://ctep.info.nih.gov/handbook/ |
