This is Vulcan Accelerator project.  

Every clinical research study involves many intervention and observation activities that must be performed by an investigator for a clinical trial participant. Typically, this is described in the study protocol as a succession of activities with a permissible interval between each one.  For a specific subject, this is instantiated into a plan with actual dates.  As the events occur, a record is comprised of the execution of the study for that specific subject.  Data integration between Research Systems (eDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) has been a consistent want for sponsors of clinical investigators and regulators.  This project intends to create a FHIR Implementation Guide for the protocol schedule that will introduce consistency, avoid repeated data entry across systems, and enable more seamless connectivity between systems used in clinical practice with those used in protocol driven research.


The core of this project is to define a usable pattern for a Clinical Trial Schedule of Activities structure using FHIR Resources and Processes, such that:

  • it can be shared
  • it can be interpreted, and
  • it can be implemented in healthcare systems (such as EHR or PHR systems)

The conduct of Clinical Trials are guided by the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) E6 (R2).  Core to this is the writing of a Clinical Trial Protocol, a document intended to describe the objectives, design, methodology, statistical considerations and aspects related to the organization of the clinical trial.

Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice (as mentioned above), and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

The Clinical Trial Protocol incorporates all the aspects of what is needed to define how the study is to be conducted and reviewed; for the purposes of this first iteration of the Implementation Guide we are constraining the scope to focus just on the elements incorporated in the Schedule of Activities.

PSS Link:   PSS-2003 - Getting issue details... STATUS

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Project Status

  • ACTIVE  (Status Date: 10/2022 )


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FHIR Resources

Last Updated: 10/2022

The resources used in this Implementation Guide are:

  • ResearchStudy
  • PlanDefinition
  • ActivityDefinition

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