Electronic Source Documentation in Clinical Investigations - Guidance for Industry

Guidance for Industry
Electronic Source Documentation in Clinical Investigations

DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact Leonard Sacks at 301-796-8502.
U.S. Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner
December 2010

pdf, 18 pages:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf

alternate FDA nexus:
Guidances