Session 15 - How good is your Central Monitoring ? Is It in sync with Ground Realities ?

  • #pioneer
Sunday, September 13, 2020: 8:00 AM - 1:00 PM
/ CEU Credits:0.2

SESSION CHAIRS & SPEAKERS

Session Chair
Abby Abraham
Global Head Data Science
Speaker
Shilpi Sinha
Bristol Myers Squibb
Chair & Speakers
Vadim Tantsyura
Sr. Director, Data Quality Science
BioMarin Pharmaceuticals

SESSION DESCRIPTION 

Over the last five years, central monitoring of data is a pivotal component to implement Risk-based monitoring (RBM). The industry is witnessing a steady adoption of central monitoring of data to monitor risks and critical data in studies. However, as per recent industry surveys, varied approaches to implementing central monitoring are observed as ICH-E6(R2) does not mandate a standard methodology of central data monitoring. As the industry is now metamorphosing from RBM to ICH-E6(R2) compliance, it is apparent that existing RBM constructs and central monitoring methodologies will need to align and operate to the broader requirement of risk-based quality management (RBQM). 

Hence, sharing perspectives of how can existing Data Management techniques be used to power central monitoring, understanding benefits and limitation of central monitoring to clinical operations is important to understand in order to align to holistic ICH-E6(R2) compliance. Also, having a view of the experience, type and skillset of central monitors will be beneficial to organizations who want to create a stable and scalable operations.


TOPIC


LEARNING OBJECTIVES

1. Utilizing existing Data Management techniques be used to power Central Monitoring
2. What are the advantages of using Central Monitoring
3. Understanding the limitations in the current model of Central Monitoring and how to improve it
4. Focusing on the right skill set, experience to have a sustained and scalable central monitoring operations

SESSION INFORMATION

CDM Certification Competencies::
Clinical Trial Processes,Edit checks and validation,Risk Based Monitoring

Target Audience:
Central Monitors,Clinical Operations,Data Management