HL7 / Vulcan-schedule-ig

An implementation guide for representation of the schedule of visits and other activities that take place in a clinical trial. Includes necessary extensions and profiles.
4 stars 2 forks source link

Protocol Amendments #29

Open mike-hamidi opened 2 years ago

mike-hamidi commented 2 years ago

URL: https://build.fhir.org/ig/HL7/Vulcan-schedule-ig/unscheduled-activities.html#use-case---protocol-amendments Comment: We mention that protocol amendments can impact how the protocol is executed. I don't believe we have an example of amendments. We may want to mention that such an example and testing were not developed in this FHIR IG.

glow-mdsol commented 2 years ago

Great point - I think the versioning in the ResearchStudy is pretty vague. I have been thinking of each study plan as a unique entity (no provenance) as versioning/changes are very difficult in something that explicitly support it (FHIR approach is pretty nascent here). I think it's worth adding a comment to this effect

metadatadriven commented 1 year ago

LoL! Came here to comment on Protocol Amendments - great to see @mike-hamidi on the case:)