Anita Walden, a Senior Informaticist at the DTMI, will serve as an instructor for the Society of Clinical Data Management, leading a five-week, instructor-facilitated online course, “Data Standards in Clinical Research.”
Beginning March 18, the course is an introduction to the CDISC, HL7, and associated clinical research standards, including the BRIDG domain model, Protocol Representation model, Clinicaltrials.gov data elements, and several therapeutic area-specific data elements.
Instruction on specific standards is bookended by an overview of standards development and practical methods for standards adoption and implementation. The course provides awareness of the standards relevant to clinical research. Topics covered include the purpose, scope (information content), format (information structure), and level of authority of each covered standard. Opportunities for additional training, documentation for each standard, and related resources will be emphasized.
A combination of online discussions, activities, and assignments support the objectives of this course.