Vulcan Schedule of Activities FHIR Implementation Guide (Jira PSS-2003)

Every research study has a number of activities that must be performed. Typically this is described in the study protocol as a succession of activities with a permissible interval between each one. For a specific Research Subject this is converted to a plan with actual dates. As the events occur a record is built up of the execution of the study for that specific subject. Less often thought about is the wider set of activities that go toward designing a study and setting it up. The mechanics of representation will be essentially the same but the consumers of the data are more likely to be the CRO (Clinical Research Organisation(s)) managing the study. This set of activities is likely to be completely independent of any patient record.

Currently each software package used in the study holds its own representation of that schedule. This leads to repeated entry of the schedule frequently leading to differences in naming for a given event and omission of other events. Management and reporting of data during a study and subsequent aggregation of data are made more difficult. CTMS software packages that hold their own representation of a Study/Protocol schedule would ideally integrate with EHRs as well as other CTMS.

Adoption of a FHIR based representation of the schedule will introduce consistency and avoid repeated data entry. It will facilitate uniform implementation of the schedule of activities across investigational sites.