Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformation/Guidances/ucm240323.htm.
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed – Draft Guidance for IRBs, Clinical Investigators and Sponsors
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM328855.pdf
Electronic Source Data in Clinical Investigations – Draft Guidance for Industry
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf
