BRIDG Deep Dive
The BRIDG Model is a Domain Analysis Model (DAM) that is being developed through a collaborative effort of stakeholders from CDISC, the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the National Cancer Institute (NCI), and the US Food and Drug Administration (FDA). This one-day workshop is a more detailed and advanced follow-up to the Intro to BRIDG course and provides a stronger understanding of the BRIDG model and helps in deciding how to leverage these domain semantics for clinical research related applications or other implementations at your organization.
This full-day workshop will cover:
- A high level overview of BRIDG Model Content
- A detailed review of the 5 sub-domains
- An introduction to the ISO data typesDetailed walk-thru of the Model using some common processes of clinical research
- Open discussion period to identify semantics for an audience generated use case
- Introduction to the BRIDG harmonization process
- How to work with the BRIDG SCC and harmonize your project semantics
Successful Course Completion
- In order for a leaner to successfully complete a course:
- An education representative or learner will complete training registration.
- A learner will complete formative assessment survey
- A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
- A learner will complete final course assessment with a score of at least 80% correct.
- A learner will complete summative assessment surveys
- Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
- If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
- If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
- If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
- If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.
Experience with modeling data structures--e.g, data models, ERD, UML, logical and physical database design, etc. Intro to BRIDG (CDISC training--optional) Basic knowledge of clinical trials concepts and proceses Experience with requirements analysis/modeling tool (e.g., Rational Rose, Enterprise Architect, Oracle Designer, ERWin, etc. (Recommended, not required)