Quality Assurance Materials

These materials are referenced in the paper “Quality Assurance of Research Protocols Conducted in the Community: The National Institute on Drug Abuse Clinical Trials Network Experience,” by Carmen Rosa, Aimee Campbell, Cynthia Kleppinger, Royce Sampson, Clare Tyson and Stephanie Mamay-Gentilin, published in Clinical Trials 2009; 6:151-161. [DOI: 10.1177/1740774509102560]. [more]

• Quality Assurance & You: A Guide to Conducting High Quality Research in the CTN (brochure)
  
• Protocol Quality Assurance Plan Template (Rev Mar 8, 2005)
  
• Protocol Data & Safety Monitoring (from CTN Policies and Procedures Guide, V1.3, Rev May 13, 2008)
  
• Protocol Violation Categories
  
• Node Protocol Pre-Initiation Worksheet (V7 – 17 Feb 2004)
  
• CTP Protocol Pre-Inititation Worksheet (V5 -05 July 2001)
  
• Site Initiation Report Form
  
• NIDA-CTN QAS Interim Monitoring Report Form

If you have questions about the content of the materials, please contact:
Carmen L. Rosa, M.S.
Center for the Clinical Trials Network
NIDA/NIH/HHS