01/15/2014

APRIL 11th: Source Data Review (SDR) vs. Source Data Verification (SDV) – A Site Monitoring Best Practices Update

Encore and updated presentation regarding Source Data Verification vs. Source Data Review.
Transcription error identification vs. Risk-based Compliance Monitoring! Can we get rid of SDV? Is this new or is this what was supposed to be happening all along?

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Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online

Course Description:
Is there a difference between source data verifying (SDV) and source data reviewing (SDR)?
The use of the abbreviation SDV is very common, but does not have consistent expectations from group to group (sponsor/ CRO, site). Some studies show that “SDV” is not a critical activity in monitoring quality data, but source data review is.
However, many defend that source data verification includes verifying data quality and compliance vs. accuracy alone. If this is the case, is SDV being performed as assumed?
This lack of clear expectations leads to data quality issues, even with SDV being defined as monitoring for data quality. This course will outline the best practices for designing and implementing SDV AND SDR programs, focusing on a risk-based approach.
Best practices are outlined in detail, and tools provided will help you find the right blend for your site monitoring activities. Questions such as, “Can SDV/SDR be done remotely?” will be answered, and other common points of confusion will be addressed.
Come to this interactive, live 90-minute session and you will be able to: • Define the differences between SDV and SDR and determine the right data monitoring path for you • Perform a risk-based gap analysis of interpretation of the definition of SDV and SDR within current practice • Update terminology to support cross-functional teams performing remote monitoring activities like source data review remotely and on-site

Hope to see you there! Please pass this on to a friend.

Thanks!
SAM
Clinical Pathways LLC, Cary NC
www.clinicalpathwaysresearch.com