This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
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.
This course is recommended for:
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.
Learning Objectives:
- Understand key differences between SDTM and ADaM models and process flows
- Understand key differences between the seven CDISC classes
- How to create Dataset.XML from SAS
- Better understand structure and syntax of ODM-XML files using examples
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
Who Will Benefit:
This course is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course. Effective and practical solutions to address real-world issues will be provided.This course is recommended for:
- SAS Statistical Programmers
- Quality Assurance Specialists
- SAS Statistical Managers
- Medical Writers
- Statisticians
- Regulatory Affairs Associates
- Clinical Data Managers
- Directors, Statistical Programming
- CRO Professionals
- Health Care Professionals
- Research University Specialists
Speaker
Sunil GuptaCourse Provider
Sunil Gupta,
