ONLINE WEBINAR · December 16, 2021, 07:00 AM PDT | 10:00 AM EDT | 16:00 CET | 19:30 IST
RBQM in CDM - Getting ready for targeted querying?
Session Overview: There is an opportunity to greatly improve CDMs efficiency & to reduce the burden on the sites by embarking on targeted querying. Are we ready for it?
OverviewOver the past years, regulators & ICH have been encouraging us to implement the principles of risk-based quality management. 100% quality does not exist; focus where it matters most. Clinical Data Management developed a very accurate data capture process - to which the back-end query process hardly adds any value. In addition, we have been developing many indicators that provide more or less real-time information on the data collection process, and that allow us to act & mitigate risks as soon as they are detected.
In this new context there is an opportunity to greatly improve CDMs efficiency & to reduce the burden on the sites by embarking on targeted querying. Are we ready for it?
What You'll Learn
- The Regulatory background of RBQM in clinical development and its implementation
- How the optimal implementation of RBQM will connect and integrate the various functions involved in the design & conduct of clinical studies
- How the availability of the right risk indicators is supporting an ongoing risk management process resulting in a continuous improvement of data quality & process efficacy
- How RBQM can strongly increase the efficiency of Clinical Data Management by helping the data managers focus on where it matters most
Who Should AttendThe audience should have a basic understanding of Clinical Data Management and be able to follow the reasoning that in this day & age the 100% backend query process may have lost parts of it's relevance, considering the proactive approaches we have been developing to manage quality in clinical develop - including data quality.
Meet the Speaker
Business Lead Data Review & Visualization, BayerPeter joined Bayer Pharma in 2017 as Business Lead for the Data Review and Visualization Environment. Wide experience in Drug Development in Europe and the US: Director Regulatory Affairs, Clinical Research Scientist, Project Director Compound Development, Senior Director Clinical Data Management at Organon, Schering-Plough, MSD. Passion for change management. Member of the Society for Clinical Data Management (SCDM) Board of Trustees, chair of the SCDM EMEA Steering Committee.
Earn CEUsSCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
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