http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
guidance for institutional review boards and clinical investigators (sponsor - investigator - IRB interrelationship)
Sponsor-investigator-IRB interrelationship
Title from HTML caption (viewed on July 20, 2009).
Mode of access: Internet at the FDA web site. Address as of 7/20/09: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126425.htm ; current access is available via PURL.