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7-8 - Quality Essentials: Monitoring Visit Report Review Plans 
Member Price:
April 18, 2016   10:15am - 11:45am
Total Credits:
1.5 CH  
  Synced Audio / Video / Slides

Whether you are the Study Manager, Monitoring Lead, Sponsor or Site, the systematic, consistent, management of a local/global trial depends/relies on quality planning. Several study-related Management Plans are developed to guide the implementation/execution of a clinical trial (e.g., Project Management, Clinical Monitoring, Trial File Management, Monitoring Visit Report Review). Each plan contributes to a comprehensive, coordinated approach to study conduct and impact the requirements/priorities for the monitoring visit. The internal MVR quality review verifies that the requirements and intent of the applicable study plans is carried out-and most importantly documented. A quality review for 'what matters most' when using multiple reviewers is critical for local/global trials. Without a MVR Review Plan, reviewers have 'their own way' that does not support quality and consistency in trial oversight and documentation.

Learning Objectives: 
  1. Describe the challenges and risk to the CRAs, CROs and Sponsors when a Monitoring Visit Review Plan (MVR) is not used.
  2. Explain three key elements of a MVR Review Plan.
  3. Summarize two best practices when implementing a MVR Review Plan in an organization.

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