CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

This training session 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. The program will provide effective and practical solutions to address real-world issues.

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 detail 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. Attendees will get a copy of the new CDSIC e-guide and all SAS macros reviewed in class.

Learning Objectives:

• Utilize metadata to automatically assign variable attributes in ADaMs
• Create and process ISO8601 dates, hierarchy of adverse events variables
• Better understand the purpose of running OpenCDISC
• Submit better FDA submissions by better understanding the technical and process review

Areas Covered in the Webinar:

• ADAM Metadata Excel File
• ISO8601 Dates, Partial Dates, Durations and Periods
• Study Validation Checklists
• SDTM and ADaM QC Forms
• OpenCDISC and SAS Clinical Standard Toolkit
• Templates - SDTM and ADaM Specifications, Defaults, Master SDTM to ADaM Map
• ISS/ISE - Master Control Terminology
• Understanding the FDA Review Process and Preventing Delays - FDA’s High Expectations
• Understanding How to Avoid FDA Review Issues - Challenges
• Sponsor’s Best Practices for Better FDA Submissions - Lessons Learned

Who Will Benefit:

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 unique course.

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