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

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

… 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

… 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

… 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

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

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

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