Why Should You Attend:
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 teach 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 get a copy of the new CDISC e-guide and all SAS macros reviewed in the program. Through case study analysis, the instructor will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.Areas Covered in the Webinar:
MindMaps - SDTM and ADaM Domains, SDTM Variable Types and Roles
CDISC Quick References
Understanding Seven CDISC Classes
Study Reference Files
SDTM and ADaM Dataset Models and Process Flows
Creating and QCing Define.xml & Dataset-XML
Creating Dataset.XML from SAS
ODM-XML File Structure and Content
Global Element Order
Understanding Tagsets
Components – Metadata, Clinical Data, Administrative, Reference and Audit
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 teach 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 get a copy of the new CDISC e-guide and all SAS macros reviewed in the program. Through case study analysis, the instructor will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.Areas Covered in the Webinar:
MindMaps - SDTM and ADaM Domains, SDTM Variable Types and Roles
CDISC Quick References
Understanding Seven CDISC Classes
Study Reference Files
SDTM and ADaM Dataset Models and Process Flows
Creating and QCing Define.xml & Dataset-XML
Creating Dataset.XML from SAS
ODM-XML File Structure and Content
Global Element Order
Understanding Tagsets
Components – Metadata, Clinical Data, Administrative, Reference and Audit
