Short Description

FDA's objective for this track is to develop HL7 FHIR capabilities to fulfill the study data submission requirements and to use of standardized RWD by biopharmaceutical sponsors to generate Real World Evidence to  submit to the FDA using established guidelines, e.g. using CDISC SDTM standard.

The January connectathon will focus on extracting patient data from an EHR FHIR server and generating an SDTM dataset to submit to FDA's Gateway for validation.

Long Description

The increase in adoption of health IT means that most patients receiving health care services now have their health data recorded electronically. However, this information is not easily accessible to clinical researchers.  Clinical Research studies currently require the redundant entry of clinical data that already typically reside in certified EHR/health IT systems.

Given the extreme cost and extended time required for randomized clinical trials, it would be substantially better to utilize EHR source data to directly populate clinical research data capture systems wherever feasible. The July 2018 FDA guidance titled Use of Electronic Health Record Data in Clinical Investigations encourages the sponsors to use EHR data as noted in the statement below.

"FDA encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as health care organizations, to use EHRs and EDC systems that are interoperable. EHRs may be interoperable with EDC systems in a variety of ways depending on supportive technologies and standards. Interoperable technology may involve automated electronic transmission of relevant EHR data to the EDC system. For example, data elements originating in an EHR (e.g., demographics, vital signs, past medical history, past surgical history, social history, medications, adverse reactions) may automatically populate the eCRFs within an EDC system."

With this background there is a clear need to develop HL7 FHIR capabilities to fulfil the requirements for study data submission for studies, where standardized Real World Data (RWD) might be leveraged by biopharmaceutical sponsors to generate Real-World Evidence in Regulatory Decision-Making.


Track Kickoff:

Wednesday, January 13, 1:00 PM – 2:00 PM Pacific (4:00 PM – 5:00 PM Eastern)

Track Days:

Day 1 - Thursday, January 14, 8:00 AM -7:00 PM Pacific (11 AM – 10 PM Eastern)

Track principals will be available for questions during Day 1 at:

10:00 AM to 11:00 AM Pacific (1:00 PM to 2:00 PM ET), and,

3:00 PM to 4:00 PM Pacific (6:00 PM to 7:00 PM ET)

Day 2 - Friday, January 15, 8:00 AM – 4:00 PM Pacific (11:00 AM – 7:00 PM Eastern)

Track principals will be available for questions this day at:

10:00 AM to 11:00 AM Pacific (1:00 PM to 2:00 PM ET), and,

Track Report Out:

Friday, January 15, 2:00 PM to 3:00 PM Pacific (5:00 PM to 6:00 PM ET)


Blue time slots indicate times where track developers/principals will be online.


Educate on the use of FHIR technology/IG.  There will be more complex tracks in future.

Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group  


Proposed Track Lead

Confluence account request - Charles Yaghmour  ( / Hugh Glover (

Related Tracks

2021-01 Vulcan - Phenopackets mapped to EHR

Schedule of Activities - Project

FHIR Version


Specification(s) this track uses

A skeletal IG will be crafted to specify the usage.

Artifacts of focus

Concomitant Medication

Clinical input requested (if any)

We invite input from any clinician on ways of achieving the objective.

Patient input requested (if any)

Patients may be interested in how they may augment their records - we are interested in any such suggestions.

Expected participants

Vulcan members, US FDA, Transcellerate members, Academic medical centers.

Zulip stream

#Vulcan/RWD>Connectathon 2021-01


Track Orientation Details

Introduction to track and track objectives.

The recording is here: Vulcan RWD 2020-12-17.mp4

and the slides are here:

Track Details

System Roles:

  • FHIR EHR Server - An EHR server pre-populated with synthetic or fully anonymized records. The connectathon will not make any changes to the data on this server.
  • FHIR-to-SDTM Mapping Capability - This capability will be developed for the connectathon. It will convert medication-related FHIR resources for a given patient to CDISC SDTM Concomitant Medication dataset, i.e. CM domain dataset. This capability will also convert the Patient FHIR resource for the same patient to CDISC SDTM Demographics dataset, i.e. DM domain dataset. For the purposes of the January connectathon other necessary CDISC SDTM domain datasets, e.g. TS/ TE/ TA, will be created manually, especially since the EHR Server is less likely to contain clinical trials related data.
  • FDA Submission Gateway - The FDA Gateway will receive the CDISC SDTM datasets and validates it. Note: The Gateway uses Pinnacle 21 to validate CDISC SDTM datasets. 


The January connectathon will focus on the following scenario: 

  1. Search for a patient in the EHR FHIR server by a patient identifier
  2. Retrieve patient’s medication records for a given period
  3. Display medication records on the UI
  4. Show the FHIR XML/JSON representation of the medication records
  5. Convert the FHIR data CDISC SDTM datasets, CM and DM domains
  6. Validate the created SDTM datasets via the FDA Gateway

The figure below depicts the data flow.


Test Script(s):

By the time of the connectathon, the team will have created a prototype to demonstrate this capability. The wireframe below show represent how it will look.

  1. The user enters a patient number in block A and clicks [Search]
  2. The system will retrieve the patient from the FHIR EHR server and display basic patient demographics information in block B, and the patient’s medications record in block C.
  3. The user can click [Display Results (XML/JSON)] to display the XML or JSON FHIR representation of the medications record
  4. The user can click [Export SDTM Dataset] and the system creates the DM (Demographics) and CM (Concomitant Medication) CDISC SDTM domain files to store on the user’s local machine.

Note: Other CDISC SDTM files necessary for the submission will be manually created, i.e. TS (Trial Summary), TE (Trial Elements), TA (Trial Arms), and define.xml. Since the server will have EHR clinical data, and no clinical trial data, the clinical trial related variable values used in these SDTM domain files will be synthetic and constant for any patient used in the prototype.

Security and Privacy Considerations:

The data used for this connectathon will be synthetic or fully anonymised.  There may be security requirements for access tot the FDA gateway for testing.