Representing a “Study Site”

[mattkoch614]

Representing a “study site” is an important concept in clinical trials, typically used to capture a diverse set of physical locations that treatment was given. How to represent this is currently a highly debated topic in FHIR - we should come to a consensus on implementation guidance.

FHIR Chat:
https://chat.fhir.org/login/

[mattkoch614]

From Lloyd McKenzie (via Zulip Chat):

Typically each "study site" will have their own ResearchStudy instance that reflects what's happening at that particular site and will have its own status (one study site might still be recruiting, another might not). The StudySubject would be tied to the site-specific ResearchStudy and those would then be aggregated within the overall ResearchStudy.

[mattkoch614]

From Hugh Glover (via Zulip Chat):

It is theoretically correct, but there is a lot of push back from people about using the ResearchStudy resource to represent a site. It doesn't make sense to most people. I think the solution may be to create a ResearchSite profile of ResearchStudy. With that proviso Lloyd is correct that each "site" may have its own version of many things that start off as being at an overall study level - protocol version, recruitment targets etc etc.

We are also expanding the definition of status on the ResearchSubject to allow better representation of the subject journey through the milestones and associated statuses. I don't think we have it quite right yet, but there may be something committed to the current build on this today.