WEBINAR · September 21, 2023, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 20:30 IST
The Data Quality Plan - A Must-Have Document No Clinical Trial Should Do Without
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Session Overview: Data Quality Plan (DQP) is a must-have tool used to identify Data Quality related Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and actions to be taken to ensure data cleanliness, integrity, readiness and quality through the Clinical Study. Well defined and executed DQP allows tracking whether there is a risk of not having enough data for the study endpoint analysis, and ensure the reliability of the study results and patients safety. Attendees of this webinar will benefit by having better understanding of the process of creating and executing Data Quality Plan, defining data quality metrics including study endpoint related metrics in standardized format, and conducting Data Quality Meetings.
Overview
The purpose of the Data Quality Plan (DQP) is to identify Data Quality related Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and actions to be taken to ensure data cleanliness, data integrity, data readiness and data quality throughout the Clinical Study. The status of discrepancies, attrition, visit compliance, deviations, safety, monitoring and the study endpoints data collection is reviewed, and discussed during regular Data Quality Meetings. Knowing whether there is a risk of not having enough data for the study endpoint analysis is always one of the key focus areas. Understanding what portion of collected data is analyzable leads to early identification of potential risk of insufficient data collection, and implementing mitigation plans. To achieve that, Study Endpoint related metrics are defined in standardized format, showing what percentage of patients who have completed endpoint visit, do have the endpoint data available.
What You'll Learn
- How to create Data Quality Plan
- What metrics should be included in the Data Quality Plan
- How to define Study Endpoint related metrics
- How to lead Data Quality Meetings
Who Should Attend
This webinar will be beneficial to beginner through advanced Data Managers with basic understanding of Clinical Data Management and Risk-based Quality Management strategy. To fully benefit from the webinar it is advised to view 'Identifying critical data - The foundation for successful RBQM adoption'.
Meet the Speaker
Diana Stelmach
Senior Clinical Data Specialist
Medtronic
Diana Stelmach has 13 years of experience working as Clinical Data Manager, ensuring that statistical information and results from clinical trials are recorded and reported accurately and in compliance with internal protocols and state regulations.
Medtronic
Diana is currently Senior Clinical Data Specialist at Medtronic. She provides Data Management leadership and expertise to clinical teams. She is involved in multiple initiatives focusing on Data Management processes improvements to increase standardization, efficiency and adoption of Risk-based approaches within Clinical Data Management.
She is passionate about Risk Based Quality Management and transformation of Clinical Data Manager role into the Clinical Data Scientist.
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Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
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