1. BR&R Biomedical Research & Regulation
The focus for Pharma, CROs and Regulators

2. Core BR&R Use Cases … Submission of Study Data to a Central Repository
Clinical trial participant registration
Submission of the registration data to ClinicalTrials.gov and other international registries
11/14/2018

3. … Core BR&R Use Cases … Submitting data to research repositories
For example oncology data for the SEER Registry
Submit subject lab data to CRO and/or sponsor
Links to Transcellerate work
Study setup and management
Identify Project/Study Milestones
Site management
11/14/2018

4. … Core BR&R Use Cases … Submitting data to research repositories
For example oncology data for the SEER Registry
Submit subject lab data to CRO and/or sponsor
Links to Transcellerate work
Sharing protocol and CRF metadata and subject data among trial stakeholders
Adverse Event Reporting
11/14/2018

5. … Core BR&R Use Cases … Study setup and management Site management
Identify Project/Study Milestones
Visit schedule part of Study Design: Visit schedule is important.
Study description as part of Study Design: Need to describe the study with potential sites.
Site management
Management of individual investigators in terms of recruiting
11/14/2018

6. BRIDG Model
The underlying Domain model for all aspects of Biomedical Research.
Provides:
common structure to express design and execution of clinical trials
Mappings to other standards such as SDTM
Integrated with FHIR
11/14/2018

7. BR&R FHIR Resources Research Subject Research Study
Profiles / Extensions for:
Adverse Event
Medication / Device
IDMP
11/14/2018

8. IDMP Identification of Medicinal Products
Joint work and implementation by FDA and EMEA
FDA implementation currently via SPL
EMEA intend to move to use FHIR