Date and Time:
TUE, 2 MAR 2021, 11:00 AM - 12:30 PM Eastern US Standard Time
Learn about the many current and forthcoming ADaM publications. ADaM is CDISC’s standard for data analysis and required for data submission to FDA (U.S.) and PMDA (Japan).
- ADaM ADNCA v1.0 details the typical dataset that can be submitted to create PK parameters. ADNCA is a sub-class of BDS , and the guidance describes the differences and additions to BDS.
- ADaM Implementation Guide v1.3 is a minor update of the ADaM Implementation Guide intended to improve alignment with the FDA Study Data Technical Conformance Guide .
- ADaM Implementation Guide Medical Devices v1.0 is intended to address the typical statistical analysis needs for clinical trials collecting data on medical devices. The guide introduces three new data structures: ADaM Device-Level Analysis dataset (ADDL), Medical Device Basic Data Structure (MDBDS), and Medical Device Occurrence Data Structure (MDOCCDS).
- ADaM Guidance for Ongoing Studies Disrupted by the COVID-19 Pandemic provides recommendations for addressing the analysis needs for data capturing epidemic/pandemic impacts on ongoing clinical trials and provides example ADSL and OCCDS datasets.
- ADaM OCCDS v1.1 recently completed a second public review to address the addition of four new variables to allow multiple treatment-emergent or on-treatment flags to handle multiple periods or other analysis needs.
- ADaM Oncology Examples details various oncology analysis needs using current ADaM dataset structures.
- ADaM Questionnaire Supplements (ADQRS) sub-team recently published the first ADaM QRS supplement, which describes the structure of a typical dataset that could be used for summarization and analysis of the Geriatric Depression Scale Short Form (GDS-SF). The sub-team also released "readme" files, which provide the rationale for not developing ADaM supplements for four single-item questionnaires, ratings and scales, and made templates available for creating both types of documents.
- ADaM Traceability Examples detail various traceability scenarios using current ADaM dataset structures.
Deb Bauer, Associate Director Biostatistics, Sanofi
Nancy Brucken, Standards Engineer, Clinical Solutions Group, an IQVIA business
Liana Forman, Associate Director Data Standards, Clinical Solutions Group, an IQVIA business
Brian Harris, Standards Developer, Senior Director, AstraZeneca
Luke Reinbolt, Lead Consultant, Clinical SAS Programmer Analyst, Navitas Data Sciences
Julia Yang, Senior Principal Clinical Statistical Developer, Medtronic