Location:
Kendle
Stefan-George-Ring 6
81929 Munich
Germany
Agenda:
Main agenda item will be the mapping of data:
Mapping from CDASH to SDTM to ADaM:
- Software solutions
- Company specific solutions
Mapping of Legacy Data, including:
- New domains
- Unscheduled visits
- Controlled terminology
- Issues not covered by Implementation Guides
Mapping - Questions:
- Discussion of questions from user group members
Other Topics:
- Use of electronic health records
- GCP compliant archiving
- New SEND standard
- FDA feedback during last CDISC US Interchange meetings
- Final ADaM compliance checks