Clinical Trial Monitoring: A Sponsor Responsibility 2017

Topics

• Why Monitor Clinical Studies
• The Sponsor`s responsibility in ensuring quality monitoring
• How does a Sponsor or Site prepare for an Audit?
• What does a Monitor look for?
• The importance of Protocol knowledge in preventing errors
• To understand the importance of a well written Clinical Trial Protocol
• What are the main strategies to improve an audit outcome?
• What are the top 6 GCP problems found by monitors?
• What types of studies are targeted for auditing?
• What does the FDA look at when Auditing/Inspecting a study?
• The Sponsors role in preparing a site for an audit

Who should Attend

• Sponsors and Principal Investigators
• Drug Development Staff
• Study Coordinators
• Clinical Research Associates
• Industry Study Sponsors of Pharmaceutical Products (Drug or Device) Research involving Human Subjects
• Project Managers at CROs