Difference between revisions of "201609ClinicalResearchTrack"
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__NOTOC__ | __NOTOC__ | ||
=Track Name= | =Track Name= | ||
| − | + | Clinical Research Track | |
==Submitting WG/Project/Implementer Group== | ==Submitting WG/Project/Implementer Group== | ||
<!-- Who is asking for this track? --> | <!-- Who is asking for this track? --> | ||
| Line 10: | Line 10: | ||
==Justification== | ==Justification== | ||
<!--Why is this an important track to include in the connectathon - include implementer need, impact on ballot, FMM readiness of the resources, etc. --> | <!--Why is this an important track to include in the connectathon - include implementer need, impact on ballot, FMM readiness of the resources, etc. --> | ||
| + | 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== | ==Proposed Track Lead== | ||
<!-- Name, email and Skype id of individual who will coordinate the track at the connectathon --> | <!-- Name, email and Skype id of individual who will coordinate the track at the connectathon --> | ||
See [[Connectathon_Track_Lead_Responsibilities]] | See [[Connectathon_Track_Lead_Responsibilities]] | ||
| + | |||
| + | Wayne Kubick, Mitra Rocca (acting); other TBD | ||
==Expected participants== | ==Expected participants== | ||
<!-- List of the individuals and/or organizations that have indicated a desire to attend the connectathon and implement this track --> | <!-- List of the individuals and/or organizations that have indicated a desire to attend the connectathon and implement this track --> | ||
| + | EHR vendors supporting FHIR API; Transcelerate BioPharma, Inc. | ||
| + | EDC Vendors TBD | ||
==Roles== | ==Roles== | ||
Please include information here regarding how much advance preparation will be required if creating a client and/or server. | Please include information here regarding how much advance preparation will be required if creating a client and/or server. | ||
<!-- Roles are sets of functionality (generally defined by a Conformance resource) that a single system can take on --> | <!-- Roles are sets of functionality (generally defined by a Conformance resource) that a single system can take on --> | ||
| − | === | + | |
| − | + | This project will work with the Patient, DAF, and Structured Data Capture tracks to simulate data-related activities in pharmaceutical randomized clinical trials. | |
| + | |||
| + | |||
| + | ===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== | ==Scenarios== | ||
<!-- What will be the actions performed by participants? --> | <!-- What will be the actions performed by participants? --> | ||
| − | ===Scenario Step 1 | + | ===Scenario Step 1 Prepopulating study research data from an EHR === |
:Action: <!--Who does what? (Use the role names listed above when referring to the participants --> | :Action: <!--Who does what? (Use the role names listed above when referring to the participants --> | ||
:Precondition: <!-- What setup is required prior to executing this step? --> | :Precondition: <!-- What setup is required prior to executing this step? --> | ||
| Line 34: | Line 47: | ||
<!-- Provide a description of each task --> | <!-- Provide a description of each task --> | ||
| + | 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. | ||
==TestScript(s)== | ==TestScript(s)== | ||
Latest revision as of 19:56, 11 July 2016
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.
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.
