CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
Website https://www.complianceonline.com/cdisc-mapping-compare-and-contrast-sdtm-and-adam-steps-webinar-trai |
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Deadline: April 24, 2019 | Date: April 24, 2019
Venue/Country: U.S.A
Updated: 2019-01-27 22:55:30 (GMT+9)
Call For Papers - CFP
CDISC requirements to create SDTMs and ADAMs are not easy to understand or apply. There are many rules and standards that must be mastered and maintained across global studies. Pharmaceutical companies and CROs supporting global studies have a need to apply proven methods that reduce confusion and improve documentation. With new members joining the study team, there should be a system to help standardize and automate the FDA submission process.This webinar will enumerate essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE). Examples of both SDTM and ADaM dataset structures will be reviewed and compared. In addition, a mapping plan from raw datasets to SDTM to ADaM datasets will also be outlined. To help assure higher quality clinical data, a QC checklist and some key edit check macros will be introduced.Participants will receive a copy of the new CDSIC e-guide and all SAS macros reviewed in class. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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