Difference between revisions of "Clinical Research Document"

Latest revision as of 13:56, 4 November 2019

Clinical Research Document describes the content pertinent to the clinical research use case required within the Retrieve Form for Data-Capture (RFD) pre-population parameter.

Summary

Clinical Research Document (CRD) is part of a set of profiles that create interoperability between EHRs and specialized research systems, resulting in EHR-enabled research. CRD is a content profile that works with the Retrieve Form for Data Capture (RFD) profile to enable a research coordinator to display a partially completed case report form within the EHR. CRD defines the pre-population data set that reduces the need for the study coordinator to re-enter data which may already exist in the patient's record. CRD leverages standard EHR export documents to accomplish this, and maps the EHR data to corresponding research formats as defined by CDISC's CDASH standard.

Benefits

CRD both saves labor and improves the quality of research data. By eliminating duplicate data entry, the use of CRD saves time in the process of completing a research case report form. By using existing EHR data to automatically pre-populate the form, CRD eliminates data entry errors, thus improving data quality.

Details

CRD is activated by the Retrieve Form for Data-capture (RFD) profile at the point where RFD retrieves a form from a research system such as an Electronic Data Capture (EDC) system. CRD defines the export document based on HL7's Continuity of Care Document, and provides a mapping to CDISC's CDASH standard.

Systems Affected

Electronic Health
Clinical Trial Management System

Specification

Profile Status: Trial Implementation

Documents:

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

Supporting Standards:

IHE Retrieve Form for Data-capture
HL7 CCD
CDISC CDASH

@@ Line 1: / Line 1: @@
+Clinical Research Document describes the content pertinent to the clinical research use case required within the Retrieve Form for Data-Capture (RFD) pre-population parameter.
@@ Line 6: / Line 5: @@
 ==Summary==
-''<Describe the profile in about a paragraph using user-oriented language.  Focus on what it accomplishes for a user (i.e. the Use Cases).  Don't get into how it works, leave that to the Details section.>''
+<p>
+Clinical Research Document (CRD) is part of a set of profiles that create interoperability between EHRs and specialized research systems, resulting in EHR-enabled research.  CRD is a content profile that works with the Retrieve Form for Data Capture (RFD) profile to enable a research coordinator to display a partially completed case report form within the EHR.  CRD defines the pre-population data set that reduces the need for the study coordinator to re-enter data which may already exist in the patient's record.  CRD leverages standard EHR export documents to accomplish this, and maps the EHR data to corresponding research formats as defined by CDISC's CDASH standard.
-''<Insert a simple graphic that, at a glance, visually summarizes what the profile is about.  Do not use an actor/transaction diagram here.  Show your graphic to someone for 5 seconds (literally) and ask them what it's about.  If what they say hits the main points in your summary paragraph, you have succeeded.  E.g. a graphic of a hospital, a clinic, and a lab with patient records moving between them.  .>''
+</p>
-''<See [[Help:Contents#Tips_.26_Tricks| Help - Tips and Tricks]] for details on inserting an image/graphic.>''
 ==Benefits==
-''<If the profile can improve Cost, Safety, Quality or Efficiency then list the specific examples of that benefit (e.g. error reduction, increased throughput) and how they come about (e.g. SWF reduces patient errors due to mistyped demographics at the modality by transfering demographics electronically from the Order Filler).  Consider using a bullet list for readability.  Such benefits help users and vendors make the business case for the profile.  If the profile does not improve any aspect of Cost, Safety, Quality or Efficiency feel free to talk about something else here.>''
+<p>
+CRD both saves labor and improves the quality of research data.  By eliminating duplicate data entry, the use of CRD saves time in the process of completing a research case report form.  By using existing EHR data to automatically pre-populate the form, CRD eliminates data entry errors, thus improving data quality.
+</p>
 ==Details==
+<p>
+CRD is activated by the Retrieve Form for Data-capture (RFD) profile at the point where RFD retrieves a form from a research system such as an Electronic Data Capture (EDC) system.  CRD defines the export document based on HL7's Continuity of Care Document, and provides a mapping to CDISC's CDASH standard.
+</p>
-''<A few paragraphs, if appropriate, providing more details (mostly in user-speak, not tech-speak) on what the profile does and how it works.>''
-''<If the user might be familiar with the mechanisms used by the profile, you can mention them here.  E.g. Evidence Documents is based on DICOM Structured Report (SR) Templates.>''
-''<If the user might have an appreciation for the problems addressed in the profile, you can mention them here, but keep it short.  E.g. Mapping HL7 Order fields to DICOM Modality Worklist attributes can be inconsistent in the marketplace, so Scheduled Workflow provides vendors with more detailed instructions.>''
 ==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.>''
+* Electronic Health
+* Clinical Trial Management System
-* ''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:''' [[Comments| Final Text]]
+'''Profile Status:''' [[Comments| Trial Implementation]]
-''<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.>''
+''http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_CRD.pdf''
-[http://www.ihe.net/Technical_Framework/index.cfm#radiology IHE Radiology Technical Framework:]
-:* [http://www.ihe.net/Technical_Framework/upload/ihe_tf_rev8.pdf Vol. 1] - Section 5 (SWF Profile)
-:* [http://www.ihe.net/Technical_Framework/upload/ihe_tf_rev8-2.pdf Vol. 2] - Sections 4.8 to 4.10, 4.14 to 4.19, and 4.23
-:* [http://www.ihe.net/Technical_Framework/upload/ihe_tf_rev8-3.pdf Vol. 3] - Appendix E
-'''Underlying Standards:'''
-''<list all the standards on which the profile is based; if possible with links to sources>''
-:* [http://dicom.nema.org DICOM]
-:* [http://www.hl7.org HL7]
-:* ...
-==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. >''
+''' Supporting Standards: '''
+<ul>
+<li> IHE Retrieve Form for Data-capture
+<li> HL7 CCD
+<li> CDISC CDASH
+</ul>
-This page is based on the [[Profile Overview Template]]
+[[Category:Profiles]]
+[[Category:QRPH Profile]]
+[[Category:CDA]]
+[[Category:RFD]]