FDA website:
http://www.fda.gov

Guidance Documents:
www.fda.gov/CDER/guidance/index.htm

Good Clinical Practices in FDA-regulated clinical trials:
http://www.fda.gov/oc/gcp/

Title 21 Code of Federal Regulations (21 CFR Part 11):
www.fda.gov/ora/compliance_ref/part11/Default.htm

Computerized Systems Used in Clinical Trials:
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm

Guidance for Industry. Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators:
http://www.fda.gov/cber/gdlns/studysub.pdf

Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance:
http://www.fda.gov/cder/guidance/959fnl.pdf

Guidance for Industry. Cancer Drug and Biological Products - Clinical Data in Marketing Applications:
http://www.fda.gov/cder/guidance/4332fnl.htm

CBER Guidances / Guidelines / Points to Consider:
www.fda.gov/cber/guidelines.htm

Electronic Regulatory Submissions and Review:
www.fda.gov/cder/regulatory/ersr

Clinical Data Standards:
www.cdisc.org

HIPAA:
http://privacyruleandresearch.nih.gov/

Office for Human Research Protections:
http://www.hhs.gov/ohrp/

ICH Guidelines:
http://www.ich.org/cache/compo/276-254-1.html

Cancer Therapy Evaluation home Page:
http://ctep.cancer.gov/

Cancer Data Standards Repository:
http://ncicb.nci.nih.gov/NCICB/infrastructure/cacore_overview/cadsr/

NCI:
http://ctep.info.nih.gov/handbook