• Introduction
• Protocol
• CVs
• Licensure
• Logs
• IRB/HRC
• Consent Forms
• Investigator Brochure/Device Manual/Package Insert
• Lab Documents
• Drug/Device Accountability
• Data Collection
• FDA
• NIH
• Sponsor
• Data and Safety Monitoring Board (DSMB)

Human Research Quality Improvement Program 2005
© Copyright 2005 Partners HealthCare System, Inc.   Last Update: 08/10/2005.