Resources

Prior Aureus Presentations:

• Disaster Proofing - A Webex presented by Alicia Pouncey Jan 11, 2006
  VISIT www.firstclinical to donate and receive the actual audio presentation
  
  
• DISASTER READINESS CHECKLIST - A PDF file for sponsors or sites Disaster Proofing
  A Webex presented by Alicia Pouncey Jan 11, 2006
  VISIT www.firstclinical to donate and receive the actual audio presentation
  
  
• DISASTER READINESS CHECKLIST
  A PDF file for sponsors or sites
  
  
• Applied Clinical Trials
• "Training for the Real World" by Barry Strack
• CenterWatch
• Declaration of Helsinki (2000)
• Medical Terms Dictionary
• CDG (Device Consultants)
• Drug, Device, and Biologic FDA Regulations Pocket Size
• Training for the Real World - Article
  
  Insurance - Clinical Trials

• Rich & Cartmill - Insurance/Bonds
• ACRP - Professional Liability Insurance/Rich & Cartmill

Hazardous Materials (HazMat) Training

• Dangerous Goods Training
• IATA Denagerous Goods Regulations 2009

United States Research Agencies and Agency Resources

• Bioresearch Monitoring
• FDA Center for Devices Homepage
• FDA Information Sheets
• Health & Human Services
• Industry Portal to FDA
• Investigators
• Investigator Debarment List
• Code of Federal Regulations
• Warning Letters
• Louisiana Medical License Verification Site
• All US States - Medical License Verification Site
• DEA Manual
• Drug Review and Related Activities in the United States - FDA FREE ONLINE TRAINING

• Clinical Trials Jobs
• Job Watch

Professional Organizations

• ACRP
• ACRP - Southeast Louisiana Chapter
• SOCRA
• DIA

Good Clinical Practice

• Title 21, Part 50 (Informed Consent)
• Title 21, Part 56 (Institutional Review Boards)
• Title 21, Part 312 (Investigational New Drug Application)
• Title 21, Part 812 (Investigational Device Exemption)
• Title 21, Part 54 (Financial Disclosure)
• Title 21, Part 11 (Electronic Records; Electronic Signatures
• Title 45, Part 46 (HHS Regulations - Protection of Human Subjectew Guidance Document - HIPAA - May 2005

IRB'sPP

• Aspire IRB, LLC
• BIOMED
• Chesapeake IRB
• Consortium of Independent Review Boards (CIRB) Member IRB Organizations
• Copernicus
• Ethical Review Committee, Inc.
• Essex IRB
• Goodwyn IRB
• Independent Review Consulting
• IRB Guidance for review of Clinical Trial Web Sites
• IRB Forum
• IRB Services
• Integ Review IRB
• Liberty IRB, Inc.
• Quorum Review IRB
• Schulman Associates IRB
• Sterling IRB
• WIRB
  

EDC- Site Assessment PP

• Vista