201609ClinicalResearchTrack

Track Name

Clinical Research Track

Submitting WG/Project/Implementer Group

Clinical Interoperability Council

Justification

Clinical Research Studies currently require direct redundant entry of clinical data that should reside in EHR systems that conform to meaningful use. As data is managed in a pharmaceutical sponsor environment, the CRF data is updated, and may vary from the original source that presented by the EHR. This leads to difficulties for regulatory inspectors and reviewers in tracing back clinical data to source data, as well as redundant duplication of effort by site personnel, and general quality issues. Given the extreme cost and extended time required for randomized clinical trials, it would be substantially better to utilize EHR source data in clinical databases more efficiently.

Proposed Track Lead

See Connectathon_Track_Lead_Responsibilities

Wayne Kubick, Mitra Rocca (acting); other TBD

Expected participants

EHR vendors supporting FHIR API; Transcelerate BioPharma, Inc. EDC Vendors TBD

Roles

Please include information here regarding how much advance preparation will be required if creating a client and/or server.

This project will work with the Patient, DAF, and Structured Data Capture tracks to simulate data-related activities in pharmaceutical randomized clinical trials.

Role 1 Name

Form Designer - creates EDC form with variable mappings to FHIR API.

Form Manager – queries API to pull EHR data that maps directly to variables on eCRF.

Scenarios

Scenario Step 1 Prepopulating study research data from an EHR

Action:

Precondition:

Success Criteria:

Bonus point:

Action: Prepopulate eCRF in EDC clinical database with data pulled via FHIR DAF from EHR

Precondition: A patient has been enrolled in a clinical study (identified by a STUDYID) and assigned a subject identifier (SUBJID) and assigned to a clinical investigator as primary caregiver in the EHR.

Success Criteria: Basic Demographics data (DOB/Age, Gender, Race) can be extracted from the EHR through the FHIR API and mapped to fields on a Demographics eCRF Current medications are displayed on a ConMeds eCRF A set of vital signs measurements (BP, Temperature, HR) are transferred to the eCRF

All data points successfully imported and can be displayed in EDC system.

Bonus point: Additional data is included A data update message (for correcting a data point in the EHR) is returned to the EHR. A standard research questionnaire is completed using SDC and returned to the EDC database.