Keyword Suggestions

Results
 
 
Account Login
 
ACRP User E-mail Address
 
 
 
ACRP Password
 
 
 
 
 

Library Navigation

 
 

Browse Conferences

 
 

Topic Categories

 
 
 
rating
7-8 - Quality Essentials: Monitoring Visit Report Review Plans 
$75.00
Purchase
Member Price:
$25.00
Date/Time:
April 18, 2016   10:15am - 11:45am
 
Total Credits:
1.5 CH  
 
Format:
       
  Synced Audio / Video / Slides
 
Share:
 

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.
 


 
 
Average Rating: (2 Ratings)
  Was great, surpassed expectations, and I would recommend this
  Was good, met expectations, and I would recommend this
  Was okay, met most expectations
  Was okay but did not meet expectations
  Was bad and I would not recommend this
 



Submit
 
Advanced Monitoring Visit Documentation: Global Regulatory Authority Inspections and Sponsors
Remote Monitoring and Access to Electronic Medical Records
FDA Inspections: Understand the Process and Manage the Consequences
CAPA Isn't Just a Compliance Tool: Maximizing Site Performance Applying CAPA Principles
CDER BIMO Compliance and Enforcement: What You Need to Know!