This webinar will provide an overview of the CDISC standards, where they fit into the overall biomedical research data flow, and why it is important for clinical data managers to be aware of them.
Then we will dive a little deeper into how the implementation of CDISC standards affects the processes of clinical data management, with a few things to consider about cross-functional planning and communication.
- Identify the CDISC standards that are used for data collection and submission to regulatory authorities
- Describe the key processes in the data lifecycle that are affected by implementing CDISC
- Discuss potential enhancements to cross-functional communication when implementing CDISC standards
Who should attend
This webinar is tailored for:
- Clinical Data Managers
- Clinical Data Management leadership
- Clinical and Database programmers
- Biostatisticians and statistical programmers
- Clinical Research operations professionals
Meet the Presenter
Shannon Labout, CCDM, Vice President of Education, CDISC
Shannon Labout is a Certified Clinical Data Manager with 20+ years’ experience in healthcare technologies, team leadership and clinical research. She is an original member of the CDASH development and leadership teams, and co-led the development of the CDASH Model. In her current role as Vice President of Education for CDISC, Shannon has global responsibility for the training program for all of the CDISC standards. She currently serves on the SCDM Board of Trustees, and as a CDISC volunteer on SDTM, CDASH and Therapeutic Area teams, and on the CDISC Standards Review Council. Shannon is frequently invited to present on CDISC standards and clinical data management topics at global industry meetings.
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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