Difference between revisions of "Clinical Research Process Content"

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==Summary==
 
==Summary==
<p>
 
 
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.
 
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.
</p>
 
<p>
 
CRPC defines the following processes for execution in the EHR:
 
<ul>
 
<li> Study Definition
 
<li> Recruitment of research subjects at the point of care
 
<li> Subject enrollment
 
<li> Generation of subject timeline of events
 
<li> Adjustment of subject timeline
 
</ul>
 
  
</p>
+
CRPC provides a framework to define processes for execution in the EHR:
 +
* Study Definition Content Module
 +
 
  
 
==Benefits==
 
==Benefits==
<p>
 
 
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.
 
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.
  
</p>
 
  
 
==Details==
 
==Details==
<p>
 
 
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.
 
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.
</p>
 
  
 
==Systems Affected==
 
==Systems Affected==
<ul>
+
* Electronic Health Record
<li> Electronic Health Record
+
* Clinical Trial Management System
<li> Electronic Data Capture
 
</ul>
 
  
 
==Specification==
 
==Specification==
  
'''Profile Status:''' [[Comments| Trial Implementation]]   
+
Profile Status: [[Comments| Trial Implementation]]   
  
'''Documents:'''
+
Documents:
 +
* [[http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_CRPC.pdf Clinical Research Process Content (CRPC) ]]
  
'' http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_CRPC.pdf ''
+
Underlying Standards:
 
+
* HL7 Biomedical Research and Regulation
 
+
* CDISC Study Design Model
'''Underlying Standards:'''
+
* Retrieve Process for Execution (RPE)
 
+
* Clinical Research Document (CRD)
:* CDISC Protocol Representation and Study Design Model
 
:* HL7 Study Design Topic
 
  
 
==See Also==
 
==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.>''
+
Documents:
 
+
* [[http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_RPE.pdf Retrieve Process for Execution (RPE) ]]
 
 
'''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]]
+
[[Category:Profiles]]
 +
[[Category:QRPH Profile]]
 +
[[Category:DocShare]]
 +
[[Category:CDA]]

Latest revision as of 15:33, 4 November 2019

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 provides a framework to define processes for execution in the EHR:

  • Study Definition Content Module


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
  • Clinical Trial Management System

Specification

Profile Status: Trial Implementation

Documents:

Underlying Standards:

  • HL7 Biomedical Research and Regulation
  • CDISC Study Design Model
  • Retrieve Process for Execution (RPE)
  • Clinical Research Document (CRD)

See Also

Documents: