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12

Supplemental Regulatory Considerations:

 

ISO Standards:

http://www.iso.org/iso/iso_catalogue/catalogue_ics.htm

 

Titles 2, 21, 42, 45, 48 of Code of Federal Regulations (CFR):

http://www.gpoaccess.gove/cfr/index.html

 

ICH Standards on GMP, GLP, GCP:

http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

 

Human Subjects Protection:

http://www.hhs.gov/ohrp/education/training/introduction.html
http://grants.nih.gov/grants/policy/hs/index.htm
http://www.cc.nih.gov/training/training.html
http://www.hhs.gov/ohrp

 

Animal Subjects Protection:

http://grants.nih.gov/grants/olaw/tutorial/index.htm
http://grants.nih.gov/grants/olaw/sampledoc/index.htm
http://grants.nih.gov/grants/olaw/olaw.htm