Implementation, Evolution And Change Management Required For Remote Source Data Verification

In this webinar, you will learn how implementation, evolution and change management are critical for a successful remote monitoring program. But how does a remote monitoring program harmonize with current Source Data Verification practices?

Remote Source Data Verification (rSDV) is a well-­defined task within our industry by Sponsors, vendors and sites, but is a relatively new practice that due to its infancy has a multitude of definitions and applications. The practices proposed, explored and piloted, range from reviewing fax transmitted source documents to video recording and archiving patient visits. The term remote Source Data Verification needs to be both defined and standardized across the industry to create a common and targeted dialog that explores the impact of different practices and technologies on both cost and achievable data integrity. 

Key Areas included in this webinar:

• Innate weaknesses of on-site monitoring
• Advantages of remote monitoring/rSDV
  • Increased accuracy
  • Reduced time to submission
  • More focus to enhance CRA activities
  • Cost savings
  • Improved recruitment
• Internal change management required
• Advantages of rSDV to fulfil ICH E6 addendum
• New Job functions required