Clinical Research Process Content
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
<List (in user terms) the types of systems they might expect to have implemented actors from this profile, e.g. RIS, PACS, HIS, CAD Workstation, etc. and for each, how it would participate.>
- PACS systems may store, manage, and/or display Evidence Documents.
- Display systems may query, retrieve and display Evidence Documents.
- Reporting workstations may retrieve, process and include details from Evidence Documents in reports
Actors & Transactions:
<Insert an actor-transaction diagram, and or list of Content Definitions>
Specification
Profile Status: Final Text <Replace "Final Text" with "Trial Implementation" or "Public Comment" as appropriate.>
Documents:
<Provide direct links to the specific volumes or supplements, and list the volume sections relevant to this profile. This is a simple inventory of official normative and informative text. If you would like to provide a reading guide or walkthrough of what is in each of the different sections for implementers or users, do that in the Profile FAQ or the Profile Implementation Page linked below. If the profile uses transactions from multiple Tech. Frameworks, repeat the structure below.>
IHE Radiology Technical Framework:
Underlying Standards:
<list all the standards on which the profile is based; if possible with links to sources>
See Also
<The following sections can be left out if there is nothing to point to. This is just to show where such information can go.>
Related Profiles
<List profiles this one depends on, profiles that depend on this one, profiles that are synergistic with this one. Start with the name of the other profile as a link and then explain the relationship.>
- Reporting Workflow [RWF] may use Evidence Documents as inputs to the reporting process.
- Simple Image & Numeric Reports [SINR] may include data copied from Evidence Documents.
- Cross-enterprise Document Sharing for Imaging [XDS-I] can be used to share Evidence Documents between sites over a network.
- Portable Data for Imaging [PDI] can store Evidence Documents on media such as CDs.
- Import Reconciliation Workflow [IRWF] can fix patient ids, etc. of Evidence Documents when importing.
Consumer Information
The Profile FAQ Template answers typical questions about what the Profile does. <Replace the link with a link to the actual FAQ page for the Profile>
The Profile Purchasing Template describes considerations when purchasing equipment to deploy this Profile. <Replace the link with a link to the actual Purchasing page for the Profile>
Implementer Information
The Profile Implementation Template provides additional information about implementing this Profile in software. <Replace the link with a link to the actual Implementation page for the Profile>
Reference Articles
<List References (good and bad) (with link if possible) to Journal Articles that mention IHE's work (and hopefully include some analysis). Go ahead, Google: IHE <Profile Name> abstract or Google: IHE <Profile Name> and under the "more" select "Scholar". You might be surprised. >
This page is based on the Profile Overview Template