Clinical Research Process Content

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Clinical Research Process Content specifies content, which is appropriate to help automate the sharing of information among systems during the clinical research process using the transactions from the Retrieve Process for Execution (RPE) profile.

Summary

Clinical Research Process Content(CRPC) is part of a set of profiles that create interoperability between EHRs and specialized research systems, resulting in EHR-enabled research. CRPC works with Retrieve Process for Execution to define workflow automation across systems such as EHRs and Clinical Research Management Systems. CRPC is a content profile, but of a particular type of content: the formal definition of processes. CRPC defines a set of processes that EHRs can execute in the completion of a clinical trial.

CRPC defines the following processes for execution in the EHR:

  • Study Definition
  • Recruitment of research subjects at the point of care
  • Subject enrollment
  • Generation of subject timeline of events
  • Adjustment of subject timeline

Benefits

CRPC addresses the need of healthcare sites to execute research processes as defined in the research protocol. In the current manual workflow, the protocol is read by the study coordinator, and steps such as enrollment and scheduling are manually entered into the site's EHR. With workflow automation provided by RPE and CRPC, the protocol can directly dictate the steps of research execution to the EHR. This, in turn, reduces the workload of the study coordinator, and lowers the cost of performing research studies at healthcare sites.

Details

The RPE profile sets up actors which hold sections of the research protocol as executable instruction sets. The Process State Manager hands off the executable instructions to the Process Activity Executor, which abides in the EHR. CRPC builds on these actors and transactions, and defines the specific processes to be executed. Through the CRPC-defined process interactions of these actors the research protocol can be executed within the EHR.

Systems Affected

  • Electronic Health Record
  • Electronic Data Capture

Specification

Profile Status: Trial Implementation

Documents:

http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_CRPC.pdf


Underlying Standards:

  • CDISC Protocol Representation and Study Design Model
  • HL7 Study Design Topic