References

For NIH sponsored studies, information pertaining to Data and Safety Monitoring Plans can be found at:

• http://grants.nih.gov/grants/guide/notice-files/not98-084.html
• http://grants.nih.gov/grants/guide/notice-files/not99-107.html.
• http://grants.nih.gov/grants/guide/notice-files/NOT-OD-oo-038.html

Good Clinical Practice Guidance can be found at:

• http://www.fda.gov/cder/guidance/959fnl.pdf
• http://www.fda.gov/oc/gcp/default.htm
• http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121

Stony Brook IRB, Committee on Research Involving Human Subjects:

• http://www.research.sunysb.edu/research/humans/humansubjects.html