Highlights: The primary objective of Clinical Data Management (CDM) is to ensure timely delivery of high-quality data which is necessary to satisfy both GCP requirements and also the statistical analysis and reporting needs. CDM data validation via the Edit checks & listings in EDC studies plays a crucial role in ensuring the data is processed & validated as per the Protocol requirements & ensures data quality.
Edit checks are rules, constraints or conditions, often programmed to flag when the data entered or collected in the study does not meet the defined criteria. Considering that the creation of the Edit checks is a quality determining step, a thorough holistic understanding of this area is essential for data validation activities.
This workshop caters to emphasize on the key aspects to be considered during edit checks creation. The agenda is designed to navigate through the protocol understanding, creation of specifications, dealing with complexities, understanding a programmer’s perspective. It also includes interactive hands-on sessions and quizzes to ensure practical knowledge application and learning.
Who should attend: Experienced & aspiring Clinical data management professionals, Students and Academics
Workshop Convener: Sachin Tonapi (LabCorp, Covance)
Workshop Organizers : Aditi Bhat (GSK), Alok Gunhal (LabCorp, Covance),