As Clinical Data Managers we are always conscious that our deliverable-a “clean” analyzable database-is of utmost importance. We will be discussing the foundational elements of a Quality Management Program and the impact on our CDM processes in evaluating the quality of our data.
The specifics of evaluating errors and their critical impact on our database will also be presented as well as identifying the best practice in calculating an error rate.
- Describe a quality system approach for assuring appropriate data quality
- Identify quality acceptance criteria
- Describe critical vs. non critical errors
- Discuss the establishment of quality criteria and quality error rates acceptance limits
- Identify “best practice” in calculating error rate
Who Should Attend:
Webinar participants will benefit from attending this webinar by gaining a better understanding of how a quality management program benefits our processes in CDM as well as the overall clinical trials initiative. By recognizing the distinction of critical errors vs. non-critical, it will provide knowledge of analysis strategies that will assist the attendee in better identifying the significance of the errors encountered in a clinical trials database.
Meet the Instructor
Denise G. Redkar-Brown, MT
Denise began her career as a Medical Technologist and made the transition to the pharmaceutical industry. After more than 25 years she has held positions in basic and clinical research and is published in the European Journal of Pharmacology for her work in pulmonary pharmacology for the implementation of the Schultz-Dale model of anaphylaxis for the characterization of the leukotriene antagonist, Accolate®, while at AstraZeneca and more recently she is published in GCPj, April 2008 discussing industry trends for Clinical Data Managers.
Denise has contributed to the successful submissions for multiple medications, biologicals and vaccines. An active member of the Educational Committee of the Society of Clinical Data Management (SCDM), Denise is chair for the group that has developed on-line training programs for the CDM discipline and is a member of teams that are preparing chapters in the Good Clinical Data Management Practices document. Denise was a member of the SCDM Board of Trustees 2012-2013.
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 assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
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