This section contains brainstorming ideas for enabling sites to share data with sponsors, even if they haven't implemented R4 and/or the clinical research FHIR resources (plan, study, subject)
Concern: Site has not implemented Research Study and Research Subject resources. What can be done in the near term?
How can the site share data with the sponsor if the site does not have research study and research site implemented (observation has an R4 extension to link observation data to the study, and research subject has a link to the site's internal patient ID)? The research subject provides a link between the patient (which is the identifier on the observations) and the research study ID.
Suggestion from team (Hugh, Hugo, Marvin, Mead, Christi): If no other option is available, it may be necessary to populate Observation.subject with the StudyID:SubjectID for now. This is NOT desirable and violates the Observation FHIR definition because observation.subject is supposed to reference patient, group, device, or location. The observation.subject.identifier should have a 'type' that distinguishes is as being a special identifier that will not link to a patient resource.
Query: Retrieve all laboratory results for a given study
Site processing: Site would need to enable the Observation query to receive a study ID (which is not part of observation prior to R4 - R4 contains an extension that links observation to study);
Site processing: Site would then have to determine which results were relevant for the study and return those results.
Contents of data file produced by query:
- Possible solution 1: have the site define study-level credentials for the sponsor to use. e.g., to see results for study A, you would use the credentials that are associated with study A's data. study information would NOT be included within the returned result set for the query. This maintains compliance with existing FHIR resources. NOTE: with this solution, the study will not be returned within the file. The sponsor / person querying would need to associate the study ID with this file/dataset through another mechanism.
- Possible solution 2: embed the study ID within the observation.subject.identifier. See note above about non-compliance with Observation FHIR resource.
Site processing: Since data are being requested at the study level, site would need to provide an identifier for the subject within the observation file. The current observation FHIR resource links to the patient resource via observation.subject.identifier.
- Possible solution 1: Use the observation.focus field for the subject ID. This can link to any other FHIR resource. The definition doesn't quite fit...."what it's about when it's not about the subject" since technically this result is about the subject
- Possible solution 2: Use the subject ID as the identifier within observation.subject.identifier. See note above about non-compliance with Observation FHIR resource.
Query: Retrieve all laboratory results for a given subject within a given study
Site processing: See above for study considerations
Site processing: Site would need to enable the observation query to receive a subject ID (which is not part of observation - observations point to
Since the query is at subject level, in theory, the subject ID would not have to be returned in the Observation file. BUT, the sponsor/person querying would need to associate the study ID and subject ID with this file/dataset through another mechanism.