Articles from BioResearch Compliance Report (December 1, 2007)

Title	Author	Type	Words
7-item 483 delivered to clinical investigator for protocol violations.	Hendrick, Kim		639
BiMo inspection FOIA log.		Brief article	177
FDA starts effort to respond to I.G. report on dwindling BiMo audits; Part 11 still a concern.	Cezanne, Jeannette		692
IRB determination letters.			78
OHRP asked to review repositories and 'previous consents' in expedited review guidance.	Cezanne, Jeannette		1421
OHRP still grappling with how to report AEs to IRBs, despite guidance.	Cezanne, Jeannette		856
XML a frequent problem with eCTD submissions; speaker says refuse-to-files are painful.	Pickett, Joseph		1036