Articles from BioResearch Compliance Report (August 1, 2006)

Title	Author	Type	Words
BiMo inspection FOIA log.			188
Definition of 'human subjects research' under Subpart A recommended for revision.	Pickett, Joseph		471
FDA to issue new guidance on computers in clinical trials via rewrite of part 11; IRB registration, international GCPs coming, too.	Pickett, Joseph		672
NIDPOE letters.			397
Non-clinical lab cited in 2-item 483 for dirty equipment.			644
PPD Development clears audit; questionable use of protocol waivers noted.			542
Prisoner participants in research should have voluntary consent procedures: IOM committee.	Pickett, Joseph		499
SACHRP creates new subcommittee to recommend guidance on 'decisionally impaired' research subjects.	Pickett, Joseph		714
Sponsor's responsibility to ensure CRO is trained and follows protocol, says FDA's Seleswki.	Pickett, Joseph		581
Warning letters.			3378