Revision as of 14:03, 22 May 2008

Introduction

This is a draft of the Clinical Research Data Capture Profile (CRD) from the QRH Domain.

Profile Abstract

Clinical Research Data Capture Profile (CRD)

CRD describes the content and format to be used within the Prepopulation Data transaction described within the RFD Integration Profile. The purpose of this profile is to support a standard set of data in CCD format which the Form Filler provides for use in Clinical Research. In addition this profile will reference the ability to convert this output into a standard case report form (Standard CRF) consisting of ODM and CDASH.

Glossary

CCD: ASTM/HL7 Continuity of Care Document (CCD)
CDASH: Clinical Data Acquisition Standards Harmonization (CDASH)
Clinical Research CCD: Refers to the CCD constrained within the Clinical Research Data Capture (CRD) profile.
Form Manager: The Form Manager actor provides the store of forms ready for use by a Form Filler.
Form Filler: The Form Filler actor retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler actor can optionally provide context information by providing pre-population xml data in the request for use by the Form Manager. The Form Filler may also specify a Form Archiver actor. The Form Archiver actor specified by the Form Filler is in addition to any Form Archiver actors specified by the Form Manager.
Form Receiver: The Form Receiver actor receives and processes completed or partially completed forms instance data from a Form Filler. Form Receiver processing is out of the scope of the profile.
Form Archiver: The Form Archiver actor receives completed or partially completed forms instance data and stores these for archival purposes.
ODM: Operational Data Model (ODM)
Retrieve Form: The Retrieve Form transaction carries the form identifier from a Form Filler to a Form Manager. The transaction also allows a Form Filler to optionally specify a Form Archiver actor as well as optionally containing context information in the form of xml data to be used in the selection and

pre-population of the requested form prior to the form being returned to the Form Filler.

RFD: Retrieve Form for Data Capture Profile (RFD)
Standard CRF: Refers to a Standard Case Report Form in a ODM format which is mapped to CDASH

Also refer to Glossary of CDISC Terms at http://www.cdisc.org/glossary/index.html

Volume I

Clinical Research Data Capture (CRD)

Dependencies

Content Profile	Dependency	Dependency Type	Purpose
Clinical Research Data Capture	RFD	Integration Profile	This is a content profile that will be used in the context of the RFD Integration profile.

Profile Name

The Clinical Research Data Capture Profile (CRD)

CRD describes the content and format to be used within the Prepopulation Data transaction described within the RFD Integration Profile. The purpose of this profile is to support a standard set of data in CCD format which the Form Filler provides for use in Clinical Research. In addition this profile will reference the ability to convert this output into a standard case report form (Standard CRF) consisting of ODM and CDASH.

Use Case

The setting for the clinical research use case is a physicians’ practice where patient care is delivered side-by-side with clinical research activities. The site, Holbin Medical Group, is a multi-site physician practice, employing over 100 physicians in a variety of specialties. Holbin’s CEO encourages the physicians to participate as site investigators for pharmaceutical-sponsored clinical trials; Holbin provides support for clinical research activities in the form of a Research Department of twelve dedicated study coordinators, mostly RNs, along with clerical and data-entry support personnel. Holbin Medical Group uses an Electronic Health Record (EHR) and a number of sponsor-provided Electronic Data Capture (EDC) systems for documenting clinical trial activities. EDC is a system for documenting clinical trial activities. EDC is a remote data entry system, provided by the research sponsor, which uses either a laptop (thick or thin client) or a web site. For our purposes, an EHR is any application which is the primary site for documenting patient care, and retrieving patient care information. Thus we include in our span of interest many systems installed today that are not quite EHRs in the strictest sense, but which would still benefit from this approach.

Holbin’s involvement in a clinical study begins when the Research Department receives a request for proposal (RFP) or a request for a feasibility assessment (EU) from a study Sponsor. The Investigator or the Study Coordinator, Patricia Zone, RN, evaluates the RFP to assess if their facility has the required patient population (clinical condition and required numbers required by the study protocol) as specified in the clinical study protocol, as well as the business viability. A major issue that must be addressed is the time needed to perform the clinical study and whether or not the site has the time to perform the study appropriately. Once these concerns are addressed satisfactorily and the site is selected for the trial, the financial aspects are addressed and the site then sends the required regulatory documentation to the Sponsor. The Sponsor then provides Protocol-specific training to the Physician Investigator and other study personnel.

During the trial set-up period, Patricia, together with the Investigator ensures that the appropriate system security is in place for this protocol, recruits patients to participate as subjects according to inclusion and exclusion criteria described in the study protocol schedules patient visits, manages data capture and data entry, ensures that IRB approval has been obtained, maintains required regulatory documents and performs all the attendant financial tasks.

Patricia, under the supervision of the Investigator contacts Corey Jones, a patient at Holbin, about participating in the trial, and Corey agrees to participate as a subject. Patricia registers Corey in the EHR as a subject in trial #1234, using the EHR’s patient index. She schedules Corey’s study visits using the EHR scheduling module, and flags the visits as pertaining to the trial #1234. After the set-up stage, the site initiates clinical trial care and trial-specific documentation.

The use case continues with current state and desired state scenarios, which describe data capture utilizing EDC technology during a patient clinical trial visit before and after the RFD implementation.

Current State

Corey Jones arrives at the clinic for a scheduled trial visit and meets with Patricia Zone for a face-to-face interview. Patricia logs into the EHR and documents the visit with a terse entry: ‘Mrs. Jones comes in for a clinical trial visit associated with study #1234.’ Patricia interviews Mrs. Jones, makes some observations, and records her observation on a source paper document. She looks up recent lab results in the EHR and records them in the Case Report Form (CRF). The EHR provides only a portion of the data required to complete the form, the rest comes from the interview and observations. (Estimates on the percentage of data required for a clinical trial that would be available in an EHR vary from 5% to 40%. Even in the best case, the EHR typically captures only a subset of the data required by a study protocol.)

The completed source document is forwarded to Bob, the data entry person. Bob identifies the CRF as belonging to trial #1234, and selects the trial #1234 EDC system, which may be housed on a dedicated laptop provided by the sponsor or may be accessible via a browser session connected to the Sponsor’s EDC system via the Internet. He takes a three ring binder off the shelf and refers to his ‘crib sheet’ to get the instructions for how to use this particular system. He logs into the EDC application, using a user name and password unique to this system, and enters the data into the correct electronic case report form (eCRF) for that trial visit. Once the source document has been processed, Bob files it in a ‘banker’s box’ as part of the permanent source record of the trial (in order to meet the requirements of the Federal Code of Regulations 21CFR 312:62).

In addition to trial #1234, Bob performs data entry on eight additional EDC systems, five on dedicated laptops and three that are web-based. The web-based EDC systems save on table space, but still require entries in the three ring binders where Bob puts his ‘crib sheets’. It is a chore to make sure that data from a particular trial gets entered into the corresponding laptop with its unique login ritual and data capture form, so Bob experiences much frustration in dealing with this unwieldy set of systems. Bob is a conscientious employee, and stays current in his work. But in many other sites the data entry person holds the CRF for a period of time before entering the data, perhaps entering data twice a month, or entering the data the week before the monitor visit occurs.

Desired State

Mrs. Jones arrives for a visit and Patricia logs into the EHR, pulls up Mrs. Jones’s record, and identifies the scheduled clinical trial visit. Because of the patient identification and scheduling steps that took place in the set-up stage, the EHR recognizes Mrs. Jones as a subject in Trial 1234, and requests an electronic case report form from trial #1234’s, using RFD. If the trial is sufficiently complex, the retrieved form may contain a list of relevant forms from the RFD Forms Manager system from which Patricia may choose. Patricia selects the appropriate form, the EHR checks Patricia’s credentials, confirms that she is empowered to view the form, and displays the form. (The data capture form is essentially the same form that an EDC system would offer for this visit, and its presentation may take on some of the look and feel of the EHR’s user interface.)

Nurse Patricia interviews Mrs. Jones and enters data into the clinical trial form as presented in the EHR. The clinical site personnel will be well acquainted with the basic data collection variables* that appear on the clinical trial form as they are consistently collected in all types/phases of clinical trials. Applicable data from the EHR database are now used to pre-populate some of the clinical trial data fields. Additional data may need to be captured interactively via the forms (which may have built-in edit checks). Upon completing the form, Patricia hits the submit button, and the EHR returns the complete form to the EDC system, using RFD. A copy of the document is archived in the site clinical trial document vault as part of the permanent source record of the trial.

*These clinical trial forms or domain modules are comprised of data collection variables identified by the Clinical Data Acquisition Standards Harmonizaation (CDASH) Initiative. The CDASH initiative identifies data collection fields that are applicable to all clinical trials regardless of therapeutic area or phase of trial. Addition data collection fields will have been added to the CDASH collection variables to capture the required therapeutic area or required fields by the study Sponsor.

Actors/Transaction

This content profile addresses the Retrieve Form [IT I-34] transaction with the Pre-population argument between the two actors, Form Filler and Form Manager. The Form Filler can request that the Form Filler context information be used by the Form Manager in the selection and/or creation of the returned form. The sharing of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile. The Retrieve Form for Data Capture embodies the Form Filler Actor and Form Manager Actor. The sharing of content or updates from one actor to the other is addressed by the use of appropriate IHE profiles described by the 2007-2008 Trial Implementation Supplements to ITI-TF v. 4.0 specifically the Retrieve Form for Data Capture (RFD) suplement.

Clinical Research Data Capture Actor Diagram

Grouping

Content Bindings with RFD

The Retrieve Form for Data Capture Profile (RFD) provides a method for gathering data within a user’s current application to meet the requirements of an external system. RFD supports the retrieval of forms by a Form Filler from a Form Manager optionally using prepopulation data sent from the Form Filler and then further describes display and completion of a form, and return of instance data from the Form Filler to the Form Reciever as well as optionally to a Form Archiver. This content profile will be bound to the prepopulation data transaction described in RFD.

For more details on these profiles, see the IHE IT Infrastructure Technical Framework.

Content profiles may impose additional requirements on the transactions used when grouped with actors from other IHE Profiles.

Options

Clinical Research Data Capture Options
Actor	Option
Form Filler	CCD Option (1) CDASH Option (2)
Form Manager	CCD Option (1) CDASH Option (2)

Note ¹: The Actor shall support at least one of these options.

Form Filler Options

CCD Option

This option defines that the Form Filler can produce a valid CCD as content for the prepopulation data transaction as defined in RFD. This valid CCD will be further constrained in volume 2 of this profile.

CDASH Option

This option defines that the Form Filler can produce a valid CDASH encoded ODM as content for the prepopulation data transaction as defined in RFD.

Form Manager Options

CCD Option

This option defines that the Form Manager can recieve a valid CCD as content for the prepopulation data transaction as defined in RFD. This valid CCD will be further constrained in volume 2 of this profile. Note the reference implementation that then supports conversion of this CCD into ODM/CDASH.

CDASH Option

This option defines that the Form Manager can recieve a valid CDASH encoded ODM as content for the prepopulation data transaction as defined in RFD. Note the reference implementation will not apply to this option as no transform is needed.

Process Flow

Clinical Research Data Capture Process Flow for CCD Option

In this CCD option, the Form Filler knows which form it wants to retrieve from the Form Manager. In addition the Form Filler wants to send the prepopulation data for this form. The CRD Profile in addition to this CCD option requires that this prepopulation data conform to the Clinical Research CCD. This CCD option requires the Form Manager to accept the Clinical Research CCD format. Inside the Form Manager there is a reference implementation (see section below) that then describes how the Form Manager could transform this Clinical Research CCD into Standard CRF. The data that was sent to the Form Manager is then bound to the form and returned to the Form Filler.

Actor Definitions

Form Manager: The Form Manager actor provides the store of forms ready for use by a Form Filler.
Form Filler: The Form Filler actor retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler actor can optionally provide context information by providing pre-population xml data in the request for use by the Form Manager. The Form Filler may also specify a Form Archiver actor. The Form Archiver actor specified by the Form Filler is in addition to any Form Archiver actors specified by the Form Manager.

Transaction Definitions

Retrieve Form: The Retrieve Form transaction carries the form identifier from a Form Filler to a Form Manager. The transaction also allows a Form Filler to optionally specify a Form Archiver actor as well as optionally containing context information in the form of xml data to be used in the selection and pre-population of the requested form prior to the form being returned to the Form Filler.

Volume II

Clinical Research Data Capture Content

Standards

CDAR2: Clinical Document Architecture, Release 2, 2005 HL7
CRS: Implementation Guide for CDA Release 2 – Level 1 and 2 – Care Record Summary (US realm), 2006, HL7.
CCD: ASTM/HL7 Continuity of Care Document (Draft)

Data Element Index

CDASH has defined domains and elements within these domains. The Clinical Research CCD described below overlays these domains. This Data Element Index is an attempt to describe which sections are intended to cover which domains.

Clinical Research Data Capture Data Elements
CDASH Domains	CCD Reference
Demography	CCD Header Information
Medical History	Active Problems, Past Medical History, and Procedures and Interventions
Concommitant Medication	Current Medications
Substance Use	Social History
Vital Signs	Vital Signs
Physical Exam	Physical Exam
Adverse Events	Allergies
Lab Test Results	Coded Results
ECG Test Results	Coded Results

Document Specification

Clinical Research Data Capture Constraints (CCD Option)
Data Element	Optionality	Template ID
Date of Birth	R	patientRole/patient/birthTime
Gender	R	patientRole/patient/administrativeGenderCode
Ethnicity	O	patientRole/patient/ethnicGroupCode
Race	R2	patientRole/patient/raceCode
Active Problems	R	1.3.6.1.4.1.19376.1.5.3.1.3.6
Past Medical History	R2	1.3.6.1.4.1.19376.1.5.3.1.3.8
Procedures and Interventions	R2	1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11
Social History	R2	1.3.6.1.4.1.19376.1.5.3.1.3.16
Current Medications	R	1.3.6.1.4.1.19376.1.5.3.1.3.19
Vital Signs	R2	1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2
Physical Exam	R2	1.3.6.1.4.1.19376.1.5.3.1.1.9.15
Allergies and Other Adverse Reactions	R	1.3.6.1.4.1.19376.1.5.3.1.3.13
Coded Results	R2	1.3.6.1.4.1.19376.1.5.3.1.3.28

Common Identifiers||STUDYID||R||Unique Identifier for a study within a submission. Common Identifiers||SITEID||R||Unique identifier for the site. Common Identifiers||SUBJID||R||Subject identifier. Common Identifiers||INVID||O||Investigator identifier. Common Identifiers||VISIT||O||Visit Name. Demography||BRTHYR||R||Year of subject’s birth. Demography||BRTHMO||R||Month of subject’s birth. Demography||BRTHDY||R2||Day of subject’s birth. Demography||BRTHTM||O||Time of subject’s birth, Demography||SEX||R||The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI – CDISC Definition). Demography||AGE||O||Numeric Age of Subject. Demography||AGEU||O||Age units. Demography||DMDTC||R2||Date of collection. Demography||"DMTM (Note: If collected, will be derived into DMDTC.)"||O||Time of collection. Demography||ETHNIC||O||A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease. Demography||RACE||R||An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity.

Clinical Research Data Capture Constraints (CDASH Option)
CDASH Domain	Clinical Database Variable Name	Optionality	Definition

Optionality Key

R	Required Section
R2	Required Section if data present
O	Optional section

Header Sample

In order to ensure sufficient coverage to the Demography Domain within CDASH there are some constraints that have been applied to the Clinical Research CCD header. Specifically the Birthdate, Sex, Ethnicity, and Race are specified.

  <recordTarget>
    <patientRole classCode="PAT">
      <id root="27143B24-E580-4F47-9405-3D0DC2BF1223" extension="1022"/>
      <addr>
        <streetAddressLine/>
        <city/>
        <state>FM</state>
        <postalCode/>
        <country>Canada</country>
      </addr>
      <telecom nullFlavor="UNK" use="HP"/>
      <patient classCode="PSN" determinerCode="INSTANCE">
        <name>
          <prefix/>
          <given>Christine</given>
          <family>Smith</family>
          <suffix/>
        </name>
        <ethnicGroupCode code="364699009" displayName="ethnic group" 
          codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
        <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1"/>
        <birthTime value="20040725"/>
        <raceCode code=”2106-3” codeSystem=”2.16.840.1.113883.5.104”/>
      </patient>
      <providerOrganization classCode="ORG" determinerCode="INSTANCE">
        <id root="2.16.840.1.113883.19.5"/>
      </providerOrganization>
    </patientRole>
  </recordTarget>

Active Problems Sample (1.3.6.1.4.1.19376.1.5.3.1.3.6)

<component>
  <section>    
    <templateId root='2.16.840.1.113883.10.20.1.11'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.6'/>
    <id root=' ' extension=' '/>
    <code code='11450-4' displayName='PROBLEM LIST'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>   
    <entry>
         :
      <!-- Required Problem Concern Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.2'/>
         :
    </entry>
       
  </section>
</component>

Past Medical History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.8)

<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.8'/>
    <id root=' ' extension=' '/>
    <code code='11348-0' displayName='HISTORY OF PAST ILLNESS'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>   
    <entry>
         :
      <!-- Required Problem Concern Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.2'/>
         :
    </entry>
       
  </section>
</component>

Procedures and Interventions Sample (1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11)

<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11'/>
    <id root=' ' extension=' '/>
    <code code='X-PROC' displayName='PROCEDURES PERFORMED'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>      
    <entry>
      Required and optional entries as described above
    </entry>
       
  </section>
</component>

Social History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.16)

<component>
  <section>    
    <templateId root='2.16.840.1.113883.10.20.1.15'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.16'/>
    <id root=' ' extension=' '/>
    <code code='29762-2' displayName='SOCIAL HISTORY'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>  
       
  </section>
</component>

Current Medications Sample (1.3.6.1.4.1.19376.1.5.3.1.3.19)

<component>
  <section>    <templateId root='2.16.840.1.113883.10.20.1.8'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.19'/>
    <id root=' ' extension=' '/>
    <code code='10160-0' displayName='HISTORY OF MEDICATION USE'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>   
    <entry>
         :
      <!-- Required Medications element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7'/>
         :
    </entry>
       
  </section>
</component>

Vital Signs Sample (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2)

<component>
  <section>    
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.25'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2'/>
    <id root=' ' extension=' '/>
    <code code='8716-3' displayName='VITAL SIGNS'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>   
    <entry>
         :
      <!-- Required Vital Signs Organizer element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.1'/>
         :
    </entry>
       
  </section>
</component>

Physical Exam Sample (1.3.6.1.4.1.19376.1.5.3.1.1.9.15)

<component>
  <section>    
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.24'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.15'/>
    <id root=' ' extension=' '/>
    <code code='29545-1' displayName='PHYSICAL EXAMINATION'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>  
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.25'/>
        <!-- Optional Vital Signs Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.16'/>
        <!-- Optional General Appearance Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.48'/>
        <!-- Optional Visible Implanted Medical Devices Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.17'/>
        <!-- Optional Integumentary System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.18'/>
        <!-- Optional Head Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.19'/>
        <!-- Optional Eyes Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.20'/>
        <!-- Optional Ears, Nose, Mouth and Throat Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.21'/>
        <!-- Optional Ears Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.22'/>
        <!-- Optional Nose Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.23'/>
        <!-- Optional Mouth, Throat, and Teeth Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.24'/>
        <!-- Optional Neck Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.25'/>
        <!-- Optional Endocrine System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.26'/>
        <!-- Optional Thorax and Lungs Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.27'/>
        <!-- Optional Chest Wall Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.28'/>
        <!-- Optional Breasts Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.29'/>
        <!-- Optional Heart Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.30'/>
        <!-- Optional Respiratory System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.31'/>
        <!-- Optional Abdomen Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.32'/>
        <!-- Optional Lymphatic System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.34'/>
        <!-- Optional Musculoskeletal System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.35'/>
        <!-- Optional Neurologic System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.36'/>
        <!-- Optional Genitalia Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.37'/>
        <!-- Optional Rectum Section content -->
      </section>
    </component>
       
  </section>
</component>

Allergies and Other Adverse Reactions Sample (1.3.6.1.4.1.19376.1.5.3.1.3.13)

<component>
  <section>    
    <templateId root='2.16.840.1.113883.10.20.1.2'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.13'/>
    <id root=' ' extension=' '/>
    <code code='48765-2' displayName='Allergies, adverse reactions, alerts'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>   
    <entry>
         :
      <!-- Required Allergies and Intolerances Concern element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.3'/>
         :
    </entry>
       
  </section>
</component>

Coded Results Sample (1.3.6.1.4.1.19376.1.5.3.1.3.28)

<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.28'/>
    <id root=' ' extension=' '/>
    <code code='30954-2' displayName='STUDIES SUMMARY'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>   
    <entry>
         :
      <!-- Required Procedure Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.16'/>
         :
    </entry> 
    <entry>
         :
      <!-- Required if known References Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4'/>
         :
    </entry>
       
  </section>
</component>

Reference Implementation

Clinical Research CCD to Standard CRF (ODM/CDASH) Crosswalk

This section is intended to be a guide as to how a Form Manager would crosswalk a Clinical Research CCD structure into a CDASH compliant ODM structure (Standard CRF). The adopted format for this transformation from one structure to the other is an XSLT. The intent is to have this XSLT not be presented here within the CRD profile and remain static, but to further develop and refine this XSLT as supplemental material. The goal is to allow additional Use Cases to drive different flavors of transformations all of which might be available to be referenced. IHE is developing processes which aren't ready at time of this publication to help maintain source control and facilitate sharing and updating of this as well as other reference transformations. When the IHE process and procedures are determined this section will refer to those documents.

XSLT Sample

<?xml version="1.0" encoding="UTF-8"?>
<!-- mapping CCD to ODM/CDASH elements -->
<xsl:stylesheet version="1.0" xmlns:xsl="http://www.w3.org/1999/XSL/Transform" 	xmlns:cda="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" exclude-result-prefixes="cda">
<xsl:output method="xml" version="1.0" encoding="UTF-8" indent="yes" omit-xml-declaration="no"/>
	
<xsl:template match="cda:ClinicalDocument">	
	<ODM xmlns:cd="http://www.cdisc.org/ns/odm/v1.3" xmlns:ds="http://www.w3.org/2000/09/xmldsig#" 
		xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ODMVersion="1.3" FileOID="CLL.003" 
		PriorFileOID="CRF_CLL_v1.6" FileType="SnapShot" Description="IHE CDASH from CCD">
		<ClinicalData>
			<SubjectData>
				<SiteRef>
					<StudyEventData>
						<!--	ODM/CDASH.CommonIdentifiers	-->
						<xsl:call-template name="demography"/>
						<!--	ODM/CDASH.SubjectCharacteristics	-->
						<xsl:call-template name="medicalHistory"/>
						<xsl:call-template name="conMeds"/>
						<xsl:call-template name="substanceAbuse"/>
						<xsl:call-template name="vitalSigns"/>
						<!-- 	ODM/CDASH.Physical Exam 	-->
						<xsl:call-template name="adverseEvents"/>
						<xsl:call-template name="labResults"/>
						<!-- 	ODM/CDASH.ECG results 	-->
					</StudyEventData>
				</SiteRef>
			</SubjectData>
		</ClinicalData>	
	</ODM>
</xsl:template>


<!--	Demography	-->
<xsl:template name="demography">
	<xsl:variable name="patientNode" select="cda:recordTarget/cda:patientRole/cda:patient"/>
	<FormData>
		<xsl:attribute name="FormOID">DemographicsForm</xsl:attribute>
		<ItemGroupData ItemGroupOID='DM'>
			<ItemData ItemOID='SEX'>
				<xsl:attribute name="value">
					<xsl:value-of select="$patientNode/cda:administrativeGenderCode/@code"/>
				</xsl:attribute>
			</ItemData>
			<ItemData ItemOID='BRTHDTC'>
				<xsl:choose>
					<xsl:when test="$patientNode/cda:birthTime/@value">
						<xsl:attribute name="value">
							<xsl:value-of select="$patientNode/cda:birthTime/@value"/>
						</xsl:attribute>
					</xsl:when>
					<xsl:otherwise>
						<xsl:attribute name="nullFlavor">UNK</xsl:attribute>
					</xsl:otherwise>
				</xsl:choose>
			</ItemData>
			<ItemData ItemOID='ETHNIC'>
				<xsl:attribute name="value">
					<xsl:value-of select="$patientNode/cda:ethnicityCode/@displayName"/>
				</xsl:attribute>
			</ItemData>
			<ItemData ItemOID='RACE'>
				<xsl:attribute name="value">
					<xsl:value-of select="$patientNode/cda:raceCode/@displayName"/>
				</xsl:attribute>
			</ItemData>
		</ItemGroupData>
	</FormData>
</xsl:template>
	

<!-- 	Medical History - looking for entries in any of the following CDA sections:  Conditions, Past Medical History, Procedures	-->
<xsl:template name="medicalHistory">
	<xsl:variable name="ccdConditions" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='11450-4']"/>
	<xsl:variable name="ccdPMH" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='11348-0']"/>
	<xsl:variable name="ccdProcedures" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='47519-4']"/>
	<xsl:variable name="conditionsCount" select="count($ccdConditions/cda:entry)"/>
	<xsl:variable name="pmhCount" select="count($ccdPMH/cda:entry)"/>
	<xsl:variable name="proceduresCount" select="count($ccdProcedures/cda:entry)"/>
	
	<xsl:if test="($conditionsCount+$pmhCount+$proceduresCount)>0">
		<FormData FormOID='MedicalHistory'>
			<xsl:for-each select="$ccdConditions/cda:entry">
				<ItemGroupData ItemGroupOID='CONDITION'>
					<xsl:call-template name="problemItemData">
						<xsl:with-param name="theNode" select="."/>
					</xsl:call-template>
				</ItemGroupData>
			</xsl:for-each>
			<xsl:for-each select="$ccdPMH/cda:entry">
				<ItemGroupData ItemGroupOID='PASTCONDITION'>
					<xsl:call-template name="problemItemData">
						<xsl:with-param name="theNode" select="."/>
					</xsl:call-template>
				</ItemGroupData>
			</xsl:for-each>
			<xsl:for-each select="$ccdProcedures/cda:entry">
				<ItemGroupData ItemGroupOID='PROCEDURE'>
					<xsl:call-template name="procedureItemData">
						<xsl:with-param name="theNode" select="."/>
					</xsl:call-template>
				</ItemGroupData>
			</xsl:for-each>		
		</FormData>
	</xsl:if>
</xsl:template>


<!-- 	CON MEDS 	-->
<xsl:template name="conMeds">
	<xsl:variable name="ccdMedication" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='10160-0']"/>
	<xsl:variable name="conMedCount" select="count($ccdMedication/cda:entry)"/>
	<xsl:if test="$conMedCount>0">
		<FormData FormDataOID='ConMedForm'>
		<xsl:for-each select="$ccdMedication/cda:entry">
			<xsl:variable name="originalTextRef" select="cda:substanceAdministration/cda:consumable/cda:manufacturedProduct/cda:manufacturedMaterial/cda:code/cda:originalText/cda:reference/@value"/>
			<xsl:variable name="originalText" select="cda:substanceAdministration/cda:consumable/cda:manufacturedProduct/cda:manufacturedMaterial/cda:code/cda:originalText"/>
			<ItemGroupData ItemGroupOID='CM'>
				<ItemData ItemDataOID='CMTRT'>
					<xsl:attribute name="value">
						<xsl:choose>
							<xsl:when test="$originalTextRef"><xsl:value-of select="//*[@ID=substring-after($originalTextRef,'#')]"/></xsl:when>
							<xsl:otherwise><xsl:value-of select="$originalText"/></xsl:otherwise>
						</xsl:choose>					
					</xsl:attribute>
				</ItemData>
				<!--	Need table to translate HL7 frequency, e.g., 6h to BID	-->
				<xsl:variable name="routeCode" select="cda:substanceAdministration/cda:routeCode/@displayName"/>
				<xsl:if test="$routeCode">
					<ItemData ItemDataOID='CMROUTE'>
						<xsl:attribute name="value"><xsl:value-of select="$routeCode"/></xsl:attribute>
					</ItemData>
				</xsl:if>
				<xsl:variable name="medStartDate" select="cda:substanceAdministration/cda:effectiveTime[@xsi:type='IVL_TS']/cda:low/@value"/>
				<xsl:if test="$medStartDate">
					<ItemData ItemDataOID='CMSTDTC'>
						<xsl:attribute name="value"><xsl:value-of select="$medStartDate"/></xsl:attribute>
					</ItemData>
				</xsl:if>
				<xsl:variable name="medEndDate" select="cda:substanceAdministration/cda:effectiveTime[@xsi:type='IVL_TS']/cda:high/@value"/>
				<xsl:if test="$medEndDate">
					<ItemData ItemDataOID='CMENDDTC'>
						<xsl:attribute name="value"><xsl:value-of select="$medEndDate"/></xsl:attribute>
					</ItemData>
				</xsl:if>		
				<xsl:variable name="medIndicationValueNode" select="cda:substanceAdministration/cda:precondition/cda:criterion/cda:value"/>
				<xsl:if test="$medIndicationValueNode/@displayName">
					<ItemData ItemDataOID='CMINDC'>
						<xsl:attribute name="value">
							<xsl:value-of select="$medIndicationValueNode/@displayName"/>
						</xsl:attribute>
						<xsl:attribute name="xsi:type">
							<xsl:value-of select="$medIndicationValueNode/@xsi:type"/>
						</xsl:attribute>
						<xsl:attribute name="code">
							<xsl:value-of select="$medIndicationValueNode/@code"/>
						</xsl:attribute>
						<xsl:attribute name="codeSystem">
							<xsl:value-of select="$medIndicationValueNode/@codeSystem"/>
						</xsl:attribute>
					</ItemData>
				</xsl:if>
				<xsl:variable name="medDoseQuantity" select="cda:substanceAdministration/cda:doseQuantity/@value"/>
				<xsl:if test="$medDoseQuantity">
					<ItemData ItemDataOID='CMDSTXT'>
						<xsl:attribute name="value">
							<xsl:value-of select="$medDoseQuantity"/>
						</xsl:attribute>
					</ItemData>
				</xsl:if>
				</ItemGroupData>
		</xsl:for-each>
		</FormData>
	</xsl:if>
</xsl:template>


<!-- 	SUBSTANCE ABUSE 	-->
<xsl:template name="substanceAbuse">
	<!-- we could look into the social history for any of a specific list of substance abuse entries...if any are present then we emit the section -->
	<!-- however, there are probably too many codes to consider....just quickly looking we see several SNOMED codes for smoking, cigarette smoking, .... -->
</xsl:template>


<!-- Vital Signs -->
<xsl:template name="vitalSigns">
	<xsl:variable name="vitalsSection" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='8716-3']"/>
	<xsl:if test="$vitalsSection/cda:entry/cda:organizer">
		<FormData FormDataOID='VSForm'>
			<xsl:for-each select="$vitalsSection/cda:entry/cda:organizer/cda:component">
				<xsl:variable name="vitalsDateTime" select="cda:observation/cda:effectiveTime/@value"/>
				<ItemGroupData ItemGroupDataOID='VS'>
					<ItemData ItemDataOID='VSDTC'>
						<xsl:attribute name="value">
							<xsl:value-of select="$vitalsDateTime"/>
						</xsl:attribute>
					</ItemData>
					<xsl:variable name="vitalsResultNode" select="cda:observation/cda:value"/>
					<ItemData ItemDataOID='VSTEST'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:observation/cda:code/@displayName"/>
						</xsl:attribute>
					</ItemData>											
					<xsl:choose>
						<xsl:when test="$vitalsResultNode/@xsi:type='PQ'">
							<ItemData ItemDataOID='VSORRES'>
								<xsl:attribute name="value"><xsl:value-of select="$vitalsResultNode/@value"/></xsl:attribute>
							</ItemData>
							<ItemData ItemDataOID='VSORRESU'>
								<xsl:attribute name="value"><xsl:value-of select="$vitalsResultNode/@unit"/></xsl:attribute>
							</ItemData>
						</xsl:when>
						<xsl:otherwise>
							<ItemData ItemDataOID='VSORRES'><xsl:attribute name="value"><xsl:value-of select="$vitalsResultNode"/></xsl:attribute></ItemData>				
						</xsl:otherwise>
					</xsl:choose>
				</ItemGroupData>
			</xsl:for-each>
		</FormData>
	</xsl:if>
</xsl:template>


<!-- 	LB 	-->
<xsl:template name="labResults">
	<xsl:variable name="LRSection" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='30954-2']"/>
	<xsl:if test="$LRSection/cda:entry/cda:organizer">
		<FormData FormDataOID='LBForm'>
			<xsl:for-each select="$LRSection/cda:entry/cda:organizer/cda:component/cda:observation">
				<ItemGroupData ItemGroupDataOID='LB'>
					<ItemData ItemDataOID='LBDTC'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:effectiveTime/@value"/>
						</xsl:attribute>
					</ItemData>
					<ItemData ItemDataOID='LBSTAT'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:statusCode/@code"/>
						</xsl:attribute>
					</ItemData>
					<ItemData ItemDataOID='LBREFID'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:id/@root"/>
						</xsl:attribute>
						<xsl:attribute name="code">
							<xsl:value-of select="cda:code/@code"/>
						</xsl:attribute>
						<xsl:attribute name="codeSystem">
							<xsl:value-of select="cda:code/@codeSystem"/>
						</xsl:attribute>
					</ItemData>
					<ItemData ItemDataOID='LBTEST'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:code/@displayName"/>
						</xsl:attribute>
					</ItemData>
					<ItemData ItemDataOID='LBORRES'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:value/@value"/>
						</xsl:attribute>
						<xsl:attribute name="xsi:type">
							<xsl:value-of select="cda:value/@xsi:type"/>
						</xsl:attribute>
					</ItemData>					
					<ItemData ItemDataOID='LBORRESU'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:value/@unit"/>
						</xsl:attribute>
					</ItemData>
					<xsl:choose>
						<xsl:when test="cda:referenceRange/cda:observationRange/cda:value/cda:low/@value">
							<ItemData ItemDataOID='LBORNRLO'>
								<xsl:attribute name="value">
										<xsl:value-of select="cda:referenceRange/cda:observationRange/cda:value/cda:low/@value"/>
								</xsl:attribute>
							</ItemData>
						</xsl:when>
						<!--<xsl:otherwise>
							<ItemData ItemDataOID='LBORNRLO'>
								<xsl:attribute name="text">
									<xsl:value-of select="cda:referenceRange/cda:observationRange/cda:text"/>
								</xsl:attribute>
							</ItemData>
						</xsl:otherwise>-->
					</xsl:choose>
					<xsl:choose>
						<xsl:when test="cda:referenceRange/cda:observationRange/cda:value/cda:high/@value">
							<ItemData ItemDataOID='LBORNRHI'>
								<xsl:attribute name="value">
										<xsl:value-of select="cda:referenceRange/cda:observationRange/cda:value/cda:high/@value"/>
								</xsl:attribute>
							</ItemData>
						</xsl:when>
						<!--<xsl:otherwise>
							<ItemData ItemDataOID='LBORNRHI'>
								<xsl:attribute name="text">
									<xsl:value-of select="cda:referenceRange/cda:observationRange/cda:text"/>
								</xsl:attribute>
							</ItemData>
						</xsl:otherwise>-->
					</xsl:choose>
					<ItemData ItemDataOID='LBNRIND'>
						<xsl:attribute name="value">
							<xsl:value-of select="cda:interpretationCode/@code"/>
						</xsl:attribute>
						<xsl:attribute name="codeSystem">
							<xsl:value-of select="cda:interpretationCode/@codeSystem"/>
						</xsl:attribute>
					</ItemData>
				</ItemGroupData>
			</xsl:for-each>
		</FormData>
	</xsl:if>
</xsl:template>


<!-- 	AE 	-->
<xsl:template name="adverseEvents">
	<xsl:variable name="aeSection" select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='48765-2']"/>
	<xsl:if test="$aeSection/cda:entry/cda:act">
		<FormData FormDataOID='AEForm'>
			<xsl:for-each select="$aeSection/cda:entry">
				<ItemDataGroup ItemDataGroupOID='AE'>
				<xsl:variable name="originalTextRef" select="cda:act/cda:entryRelationship/cda:observation/cda:participant/cda:participantRole/cda:playingEntity/cda:code/cda:originalText/cda:reference/@value"/>
				<xsl:variable name="codedDisplayName" select="cda:act/cda:entryRelationship/cda:observation/cda:participant/cda:participantRole/cda:playingEntity/cda:code/@displayName"/>
				<ItemData ItemDataOID='AETERM'>
					<xsl:attribute name="value">
						<xsl:choose>
							<xsl:when test="$originalTextRef"><xsl:value-of select="//*[@ID=substring-after($originalTextRef,'#')]"/></xsl:when>
							<xsl:otherwise><xsl:value-of select="$codedDisplayName"/></xsl:otherwise>
						</xsl:choose>
					</xsl:attribute>
				</ItemData>
				<xsl:variable name="aeStartDateTime" select="cda:act/cda:entryRelationship/cda:observation/cda:effectiveTime/@value"/>
				<xsl:if test="$aeStartDateTime">
					<ItemData ItemDataOID='AESTDTC'>
						<xsl:attribute name="value">
							<xsl:value-of select="$aeStartDateTime"/>
						</xsl:attribute>
					</ItemData>
				</xsl:if>
			</ItemDataGroup>
			</xsl:for-each>
		</FormData>
	</xsl:if>
</xsl:template>


<!-- helper templates -->
<!-- CDASH a med history item -->
<xsl:template name="problemItemData">
<xsl:param name="theNode"/>
	<!-- we may be pointed to the text of the condition, or we may just have a coded value display name -->
	<xsl:variable name="originalTextRef" select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:text/cda:reference/@value"/>
	<xsl:variable name="codedValue" select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:value/@displayName"/>
	<xsl:variable name="valueNode" select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:value"/>
	<!-- problem status translates into the CDASH MHONG -->
	<xsl:variable name="problemStatusNode" select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:entryRelationship/cda:observation[cda:code/@code='33999-4']"/>
	<!-- can have status coded or by reference -->
	<xsl:variable name="problemStatusRef" select="$problemStatusNode/cda:text/cda:reference/@value"/>
	<!-- onset and end dates for problems -->
	<xsl:variable name="problemOnset" select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:effectiveTime/cda:low/@value"/>
	<xsl:variable name="problemResolved" select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:effectiveTime/cda:high/@value"/>
	<ItemData ItemOID='MHTERM'>
		<xsl:choose>
			<xsl:when test="string-length($codedValue)>0">
				<xsl:attribute name="value">
					<xsl:value-of select="$codedValue"/>
				</xsl:attribute>
				<xsl:attribute name="xsi:type">
					<xsl:value-of select="$valueNode/@xsi:type"/>
				</xsl:attribute>
				<xsl:attribute name="code">
					<xsl:value-of select="$valueNode/@code"/>
				</xsl:attribute>
				<xsl:attribute name="codeSystem">
					<xsl:value-of select="$valueNode/@codeSystem"/>
				</xsl:attribute>
			</xsl:when>
			<xsl:when test="string-length($originalTextRef)>0">
				<xsl:attribute name="value">
					<xsl:value-of select="//*[@ID=substring-after($originalTextRef,'#')]"/>
				</xsl:attribute>
			</xsl:when>
			<xsl:otherwise>
				<xsl:attribute name="value">
					???
				</xsl:attribute>
			</xsl:otherwise>
		</xsl:choose>
	</ItemData>
	<ItemData ItemOID='MHONG'>
		<xsl:attribute name="value">
			<xsl:choose>
				<xsl:when test="$problemStatusNode/cda:value/@displayName='Active'">ONGOING</xsl:when>
				<xsl:when test="//*[@ID=substring-after($problemStatusRef,'#')]='Active'">ONGOING</xsl:when>
				<xsl:otherwise>RESOLVED</xsl:otherwise>
			</xsl:choose>
		</xsl:attribute>
	</ItemData>
	<!--<xsl:comment>research adding type and category (MHCAT, MHSCAT)</xsl:comment>-->
	<!-- NOTE:  might need a more generic template to handle the multiple ways that time can be reported in ccd -->
	<xsl:if test="$problemOnset">
		<ItemData ItemDataOID='MHSTDTC'>
			<xsl:attribute name="value">
				<xsl:value-of select="$problemOnset"/>
			</xsl:attribute>
		</ItemData>
	</xsl:if>
	<xsl:if test="$problemResolved">
		<ItemData ItemDataOID='MHENDDTC'>
			<xsl:attribute name="value">
				<xsl:value-of select="$problemResolved"/>
			</xsl:attribute>
		</ItemData>
	</xsl:if>
</xsl:template>


<xsl:template name="procedureItemData">
<xsl:param name="theNode"/>
	<xsl:variable name="originalTextRef" select="$theNode/cda:procedure/cda:code/cda:originalText/cda:reference/@value"/>
	<xsl:variable name="codedValue" select="$theNode/cda:procedure/cda:code/@displayName"/>
	<ItemData ItemOID='MHTERM'>
		<xsl:attribute name="value">
			<xsl:choose>
				<xsl:when test="string-length($originalTextRef)>0"><xsl:value-of select="//*[@ID=substring-after($originalTextRef,'#')]"/></xsl:when>
				<xsl:when test="string-length($codedValue)>0"><xsl:value-of select="$codedValue"/></xsl:when>
				<xsl:otherwise>???</xsl:otherwise>
			</xsl:choose>
	</xsl:attribute>
	</ItemData>
	<!-- NOTE: is this true = procedures are RESOLVED -->
	<ItemData ItemDataOID='MHONG' value='RESOLVED'/>
	<!--<xsl:comment>??? what to do about an effectiveTime of center ???</xsl:comment>-->
</xsl:template>
</xsl:stylesheet>

Sample Standard CRF output from the Sample XSLT

<?xml version="1.0"?>
<ODM ODMVersion="1.3" FileOID="CLL.003" PriorFileOID="CRF_CLL_v1.6" FileType="SnapShot" Description="IHE CDASH from CCD" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:cd="http://www.cdisc.org/ns/odm/v1.3" xmlns:ds="http://www.w3.org/2000/09/xmldsig#">
	<ClinicalData>
		<SubjectData>
			<SiteRef>
				<StudyEventData>
					<FormData FormOID="DemographicsForm">
						<ItemGroupData ItemGroupOID="DM">
							<ItemData ItemOID="SEX" value="M"/>
							<ItemData ItemOID="BRTHDTC" value="19320924"/>
							<ItemData ItemOID="ETHNIC" value=""/>
							<ItemData ItemOID="RACE" value=""/>
						</ItemGroupData>
					</FormData>
					<FormData FormOID="MedicalHistory">
						<ItemGroupData ItemGroupOID="CONDITION">
							<ItemData ItemOID="MHTERM" value="Asthma" xsi:type="CD" code="195967001" codeSystem="2.16.840.1.113883.6.96"/>
							<ItemData ItemOID="MHONG" value="ONGOING"/>
							<ItemData ItemDataOID="MHSTDTC" value="1950"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CONDITION">
							<ItemData ItemOID="MHTERM" value="Pneumonia" xsi:type="CD" code="233604007" codeSystem="2.16.840.1.113883.6.96"/>
							<ItemData ItemOID="MHONG" value="RESOLVED"/>
							<ItemData ItemDataOID="MHSTDTC" value="199701"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CONDITION">
							<ItemData ItemOID="MHTERM" value="Pneumonia" xsi:type="CD" code="233604007" codeSystem="2.16.840.1.113883.6.96"/>
							<ItemData ItemOID="MHONG" value="RESOLVED"/>
							<ItemData ItemDataOID="MHSTDTC" value="199903"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CONDITION">
							<ItemData ItemOID="MHTERM" value="Myocardial infarction" xsi:type="CD" code="22298006" codeSystem="2.16.840.1.113883.6.96"/>
							<ItemData ItemOID="MHONG" value="RESOLVED"/>
							<ItemData ItemDataOID="MHSTDTC" value="199701"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="PROCEDURE">
							<ItemData ItemOID="MHTERM" value="Total hip replacement, left"/>
							<ItemData ItemDataOID="MHONG" value="RESOLVED"/>
						</ItemGroupData>
					</FormData>
					<FormData FormDataOID="ConMedForm">
						<ItemGroupData ItemGroupOID="CM">
							<ItemData ItemDataOID="CMTRT" value="Albuterol inhalant"/>
							<ItemData ItemDataOID="CMROUTE" value="Inhalation, oral"/>
							<ItemData ItemDataOID="CMINDC" value="Wheezing" xsi:type="CE" code="56018004" codeSystem="2.16.840.1.113883.6.96"/>
							<ItemData ItemDataOID="CMDSTXT" value="2"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CM">
							<ItemData ItemDataOID="CMTRT" value="Clopidogrel"/>
							<ItemData ItemDataOID="CMDSTXT" value="1"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CM">
							<ItemData ItemDataOID="CMTRT" value="Metoprolol"/>
							<ItemData ItemDataOID="CMDSTXT" value="1"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CM">
							<ItemData ItemDataOID="CMTRT" value="Prednisone"/>
							<ItemData ItemDataOID="CMSTDTC" value="20000328"/>
							<ItemData ItemDataOID="CMDSTXT" value="1"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupOID="CM">
							<ItemData ItemDataOID="CMTRT" value="Cephalexin"/>
							<ItemData ItemDataOID="CMSTDTC" value="20000328"/>
							<ItemData ItemDataOID="CMENDDTC" value="20000404"/>
							<ItemData ItemDataOID="CMDSTXT" value="1"/>
						</ItemGroupData>
					</FormData>
					<FormData FormDataOID="VSForm">
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="19991114"/>
							<ItemData ItemDataOID="VSTEST" value="Body height"/>
							<ItemData ItemDataOID="VSORRES" value="177"/>
							<ItemData ItemDataOID="VSORRESU" value="cm"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="19991114"/>
							<ItemData ItemDataOID="VSTEST" value="Body weight"/>
							<ItemData ItemDataOID="VSORRES" value="86"/>
							<ItemData ItemDataOID="VSORRESU" value="kg"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="19991114"/>
							<ItemData ItemDataOID="VSTEST" value="Systolic BP"/>
							<ItemData ItemDataOID="VSORRES" value="132"/>
							<ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="19991114"/>
							<ItemData ItemDataOID="VSTEST" value="Diastolic BP"/>
							<ItemData ItemDataOID="VSORRES" value="86"/>
							<ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="20000407"/>
							<ItemData ItemDataOID="VSTEST" value="Body height"/>
							<ItemData ItemDataOID="VSORRES" value="177"/>
							<ItemData ItemDataOID="VSORRESU" value="cm"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="20000407"/>
							<ItemData ItemDataOID="VSTEST" value="Body weight"/>
							<ItemData ItemDataOID="VSORRES" value="88"/>
							<ItemData ItemDataOID="VSORRESU" value="kg"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="20000407"/>
							<ItemData ItemDataOID="VSTEST" value="Systolic BP"/>
							<ItemData ItemDataOID="VSORRES" value="145"/>
							<ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="VS">
							<ItemData ItemDataOID="VSDTC" value="20000407"/>
							<ItemData ItemDataOID="VSTEST" value="Diastolic BP"/>
							<ItemData ItemDataOID="VSORRES" value="88"/>
							<ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
						</ItemGroupData>
					</FormData>
					<FormData FormDataOID="AEForm">
						<ItemDataGroup ItemDataGroupOID="AE">
							<ItemData ItemDataOID="AETERM" value="Penicillin"/>
						</ItemDataGroup>
						<ItemDataGroup ItemDataGroupOID="AE">
							<ItemData ItemDataOID="AETERM" value="Aspirin"/>
						</ItemDataGroup>
						<ItemDataGroup ItemDataGroupOID="AE">
							<ItemData ItemDataOID="AETERM" value="Codeine"/>
						</ItemDataGroup>
					</FormData>
					<FormData FormDataOID="LBForm">
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200003231430"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="107c2dc0-67a5-11db-bd13-0800200c9a66" code="30313-1" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="HGB"/>
							<ItemData ItemDataOID="LBORRES" value="13.2" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="g/dl"/>
							<ItemData ItemDataOID="LBNRIND" value="N" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200003231430"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="8b3fa370-67a5-11db-bd13-0800200c9a66" code="33765-9" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="WBC"/>
							<ItemData ItemDataOID="LBORRES" value="6.7" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="10+3/ul"/>
							<ItemData ItemDataOID="LBORNRLO" value="4.3"/>
							<ItemData ItemDataOID="LBORNRHI" value="10.8"/>
							<ItemData ItemDataOID="LBNRIND" value="N" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200003231430"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="80a6c740-67a5-11db-bd13-0800200c9a66" code="26515-7" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="PLT"/>
							<ItemData ItemDataOID="LBORRES" value="123" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="10+3/ul"/>
							<ItemData ItemDataOID="LBORNRLO" value="150"/>
							<ItemData ItemDataOID="LBORNRHI" value="350"/>
							<ItemData ItemDataOID="LBNRIND" value="L" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200004061300"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="a40027e1-67a5-11db-bd13-0800200c9a66" code="2951-2" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="NA"/>
							<ItemData ItemDataOID="LBORRES" value="140" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="meq/l"/>
							<ItemData ItemDataOID="LBORNRLO" value="135"/>
							<ItemData ItemDataOID="LBORNRHI" value="145"/>
							<ItemData ItemDataOID="LBNRIND" value="N" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200004061300"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="a40027e2-67a5-11db-bd13-0800200c9a66" code="2823-3" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="K"/>
							<ItemData ItemDataOID="LBORRES" value="4.0" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="meq/l"/>
							<ItemData ItemDataOID="LBORNRLO" value="3.5"/>
							<ItemData ItemDataOID="LBORNRHI" value="5.0"/>
							<ItemData ItemDataOID="LBNRIND" value="N" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200004061300"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="a40027e3-67a5-11db-bd13-0800200c9a66" code="2075-0" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="CL"/>
							<ItemData ItemDataOID="LBORRES" value="102" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="meq/l"/>
							<ItemData ItemDataOID="LBORNRLO" value="98"/>
							<ItemData ItemDataOID="LBORNRHI" value="106"/>
							<ItemData ItemDataOID="LBNRIND" value="N" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
						<ItemGroupData ItemGroupDataOID="LB">
							<ItemData ItemDataOID="LBDTC" value="200004061300"/>
							<ItemData ItemDataOID="LBSTAT" value="completed"/>
							<ItemData ItemDataOID="LBREFID" value="a40027e4-67a5-11db-bd13-0800200c9a66" code="1963-8" codeSystem="2.16.840.1.113883.6.1"/>
							<ItemData ItemDataOID="LBTEST" value="HCO3"/>
							<ItemData ItemDataOID="LBORRES" value="35" xsi:type="PQ"/>
							<ItemData ItemDataOID="LBORRESU" value="meq/l"/>
							<ItemData ItemDataOID="LBORNRLO" value="18"/>
							<ItemData ItemDataOID="LBORNRHI" value="23"/>
							<ItemData ItemDataOID="LBNRIND" value="H" codeSystem="2.16.840.1.113883.5.83"/>
						</ItemGroupData>
					</FormData>
				</StudyEventData>
			</SiteRef>
		</SubjectData>
	</ClinicalData>
</ODM>

@@ Line 236: / Line 236: @@
 |-
 Demography||RACE||R||An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity.
-|-
-Subject Characteristics||SCDTC||R2||Date of collection.
-|-
-Subject Characteristics||"SCTM
-(Note: If collected, will be derived into SCDTC.)"||O||Time of collection.
-|-
-Subject Characteristics||||O||The age (in weeks) of the newborn infant, counted from the first day of the woman’s last menstrual period (LMP) or health status indicators / Clinical Estimate (CE).
-|-
-Subject Characteristics||SCTESTCD ||O||Natural eye color
-|-
-Subject Characteristics||SCTESTCD ||O||Subject’s childbearing potential
-|-
-Subject Characteristics||SCTESTCD ||O||Education level achieved at start of study (Reference date)
-|-
-Subject Characteristics||SCTESTCD ||O||Sub-study participation information.
-|-
-Medical History||MHTERM||R||Verbatim or preprinted CRF term for the medical condition or event.
-|-
-Medical History||MHONG||R||Identifies the end of the event as being ONGOING or RESOLVED.
-|-
-Medical History||MHYN||O||"Lead prompt for the Medical History
-(e.g., “Has the subject experienced any past and / or concomitant diseases or past surgeries?”)."
-|-
-Medical History||MHSPID||O||O sponsor-defined reference number (e.g., Preprinted line number).
-|-
-Medical History||MHCAT||O||Used to define a category of related records (e.g., CARDIAC or GENERAL).
-|-
-Medical History||MHSCAT||O||A categorization of the condition or event pre-printed on the CRF or instructions.
-|-
-Medical History||MHOCCUR||O||A pre-printed prompt used to indicate whether or not a medical condition has occurred.
-|-
-Medical History||MHSTDTC||O||Start Date of Medical History Event.
-|-
-Medical History||MHENDTC||O||End Date/Time of Medical History Event.
-|-
-Concommitant Medication||CMYN||O||General prompt question to aid in monitoring and data cleaning.
-|-
-Concommitant Medication||CMSPID||O||A sponsor-defined reference number.
-|-
-Concommitant Medication||CMTRT||R||Verbatim drug name that is either pre-printed or collected on a CRF.
-|-
-Concommitant Medication||CMINGRD||O||Medication Ingredients.
-|-
-Concommitant Medication||CMINDC||R2||"The reason for administration of a concomitant (non-study) medication. (e.g., Nausea, Hypertension)
-This is not the pharmacological/ therapeutic classification of an agent (e.g., antibiotic, analgesic, etc.), but the reason for its administration to the subject."
-|-
-Concommitant Medication||AESPID||O||Identifier for the adverse event that is the indication for this medication.
-|-
-Concommitant Medication||CMDOSTOT||R2||Total daily dose taken.
-|-
-Concommitant Medication||CMDOSFRM||O||Name of the pharmaceutical dosage form (e.g., tablets, capsules, syrup) of delivery for the drug.
-|-
-Concommitant Medication||CMDOSFRQ||O||How often the medication was taken (e.g., BID, every other week, PRN).
-|-
-Concommitant Medication||"CMDSTXT
-(Note: If collected, will be derived into CMDOSTXT or CMDOSE.)"||O||The dose of medication taken per administration.
-|-
-Concommitant Medication||CMDOSU||O||Within structured dosage information, the unit associated with the dose (e.g., "mg" in "2mg three times per day).
-|-
-Concommitant Medication||CMDOSRGM||O||Within structured dosage information, the number of units for the interval (e.g., in oncology where drug is given 1 week on, and 3 weeks off).
-|-
-Concommitant Medication||CMROUTE||R2||Identifies the route of administration of the drug.
-|-
-Concommitant Medication||CMSTDTC||R||Date when the medication was first taken.
-|-
-Concommitant Medication||CMSTRF||||Relative time frame that the medication was first taken with respect to the sponsor-defined reference period.
-|-
-Concommitant Medication||"CMSTTM
-(Note: If collected, will be derived into CMSTDTC.)"||R2||Time the medication was started.
-|-
-Concommitant Medication||CMENDTC||R||Date that the subject stopped taking the medication.
-|-
-Concommitant Medication||"CMENRF
-CMONGO
-(Note: If collected, will be derived into CMENRF.)"||O||Indicates medication is ongoing when no End/Stop Date is provided.
-|-
-Concommitant Medication||"CMENTM
-(Note: If collected, will be derived into CMENDTC.)"||R2||Time when the subject stopped taking the medication.
-|-
-Substance Use||SUTRT ||R||The type of substance (e.g., TOBACCO, ALCOHOL, CAFFEINE, etc. Or CIGARETTES, CIGARS, COFFEE, etc.).
-|-
-Substance Use||SUNCF||R||Substance Use Occurrence.
-|-
-Substance Use||SUCAT ||O||Used to define a category of related records (e.g., TOBACCO, ALCOHOL, CAFFEINE, etc.).
-|-
-Substance Use||SUDOSTXT||O||Substance use consumption amounts or a range of consumption information collected in text form [e.g., 1-2 (packs), 8 (ounces), etc.].
-|-
-Substance Use||SUDOSU||O||Units for SUDOSTXT (e.g., PACKS, OUNCES, etc.).
-|-
-Substance Use||SUDOSFRQ||O||Usually expressed as the number of uses consumed per a specific interval (e.g., PER DAY, PER WEEK, OCCASIONAL).
-|-
-Substance Use||SUSTDTC||O||Date substance use started.
-|-
-Substance Use||"SUSTTM
-(Note: If collected, will be derived into SUSTDTC.)"||O||Time substance use started.
-|-
-Substance Use||SUENDTC||O||Date substance use ended.
-|-
-Substance Use||"SUENTM
-(Note: If collected, will be derived into SUENDTC.)"||O||Time substance use ended.
-|-
-Substance Use||SUDUR||O||The duration of the substance use.
-|-
-Vital Signs||VSDTC||R2||Date of measurements
-|-
-Vital Signs||VSSPID||O||Sponsor defined reference number
-|-
-Vital Signs||VISITDY||O||Study day of measurements, measured as integer days
-|-
-Vital Signs||VSTPT||O||Text description of time when measurement should be taken
-|-
-Vital Signs||"VSTM
-(Note: If collected, will be derived into VSDTC.)"||O||Time of measurements.
-|-
-Vital Signs||VSTEST||R||Verbatim name of the test or examination used to obtain the measurement or finding.
-|-
-Vital Signs||VSSTAT||R2||Used to indicate that a vital signs measurement was not done.
-|-
-Vital Signs||VSORRES||R||Result of the vital signs measurement as originally received or collected.
-|-
-Vital Signs||VSORRESU||R||Original units in which the data were collected.
-|-
-Vital Signs||VSLOC||R2||Location on body where measurement was performed.
-|-
-Vital Signs||VSPOS||R||Position  of the subject during a measurement or examination.
-|-
-Physical Exam - Best Practice Approach||PESTAT||O||Used to indicate if exam was not done as scheduled.
-|-
-Physical Exam - Best Practice Approach||PEDTC||O||Date of examination.
-|-
-Physical Exam - Best Practice Approach||"PETM
-(Note: If collected, will be derived into PEDTC.)"||O||Time of examination.
-|-
-Physical Exam - Traditional Approach||PEDONE||O||Used to indicate if exam was not done as scheduled.
-|-
-Physical Exam - Traditional Approach||PEDTC||R2||Date of examination.
-|-
-Physical Exam - Traditional Approach||"PETM
-(Note: If collected, will be derived into PEDTC.)"||O||Time of examination.
-|-
-Physical Exam - Traditional Approach||PESPID||O||Sponsor defined reference number.
-|-
-Adverse Events||AEYN||O||General prompt question to aid in monitoring and data cleaning.
-|-
-Adverse Events||AESPID||O||A sponsor-defined reference number.
-|-
-Adverse Events||AETERM||R||Verbatim (i.e., investigator reported term) description of the adverse event.
-|-
-Adverse Events||AESER||R||Indicates whether or not the adverse event is determined to be “serious” according to the protocol.
-|-
-Adverse Events||"AESERTP **
-Or
-AESCAN
-AESCONG
-AESDISAB
-AESDTH
-AESHOSP
-AESLIFE
-AESOD
-AESMIE
-(see below)"||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESCAN||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESCONG||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESDISAB||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESDTH||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESHOSP||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESLIFE||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESOD||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESMIE||O||Captures the criteria required by protocol for determining why an event is “Serious”.
-|-
-Adverse Events||AESTDTC||R||Date when the adverse event started.
-|-
-Adverse Events||"AESTTM
-(Note: If collected, will be  derived into AESTDTC.)"||R2||Time when the adverse event started.
-|-
-Adverse Events||AEENDTC||R||Date when the adverse event resolved.
-|-
-Adverse Events||"AEENRF
-AEONGO"||O||Indicates AE is ongoing when no End/Stop date is provided.
-|-
-Adverse Events||"AEENTM
-(Note: If collected, will be  derived into AEENDTC.)"||R2||Time when the adverse event resolved.
-|-
-Adverse Events||"AESEV
-And/or
-AETOXGR"||R||Description of the severity of the adverse event.
-|-
-Adverse Events||AEREL||R||Indication of whether the investigational product had a causal effect on the adverse event, as reported by the clinician/investigator.
-|-
-Adverse Events||AERELTP||R2||Captures a category for an investigational product to which an adverse event is related.
-|-
-Adverse Events||AEACN||R||Action(s) taken with the investigational product in response to the adverse event.
-|-
-Adverse Events||AEACNOTH||O||Describes Other Action(s) taken in response to the adverse event. (Does not include investigational products)
-|-
-Adverse Events||AEOUT||R||Description of the subject’s status associated with an event.
-|-
-Lab Test Results - Scenario 1: Central processing||LBDTC||R ||Date of sample collection.
-|-
-Lab Test Results - Scenario 1: Central processing||"LBTM
-(Note: If collected, will be derived into LBDTC.)"||R2||Time of collection.
-|-
-Lab Test Results - Scenario 1: Central processing||LBSTAT||R ||Status of whether or not lab was done.
-|-
-Lab Test Results - Scenario 1: Central processing||"LBCAT
-LBSCAT"||R2||Type of draw / category / panel name. Used to define a category of related records.
-|-
-Lab Test Results - Scenario 1: Central processing||LBTPT||R2||Relative time for use when multiple sequential assessments are done.
-|-
-Lab Test Results - Scenario 1: Central processing||LBFAST (for example)||R2||Conditions for sampling defined in the protocol.
-|-
-Lab Test Results - Scenario 1: Central processing||LBREFID||R2||Internal or external specimen identifier.
-|-
-Lab Test Results - Scenario 2: Local processing||LBDTC||R ||Date of sample collection.
-|-
-Lab Test Results - Scenario 2: Local processing||"LBTM
-(Note: If collected, will be derived into LBDTC.)"||R2||Time of collection.
-|-
-Lab Test Results - Scenario 2: Local processing||LBSTAT||R ||Status of whether or not lab was done.
-|-
-Lab Test Results - Scenario 2: Local processing||"LBCAT
-LBSCAT"||R2||Type of draw / category / panel name. Used to define a category of related records.
-|-
-Lab Test Results - Scenario 2: Local processing||LBTPT||R2||Relative time for use when multiple sequential assessments are done.
-|-
-Lab Test Results - Scenario 2: Local processing||LBFAST (for example)||R2||Conditions for sampling defined in the protocol.
-|-
-Lab Test Results - Scenario 2: Local processing||LBSPCCND||R2||Free or standardized text describing the condition of the specimen.
-|-
-Lab Test Results - Scenario 2: Local processing||"LBTESTCD
-And/or
-LBTEST
-"||R ||Verbatim name of the test or examination used to obtain the measurement or finding. Note any test normally performed by a clinical laboratory is considered a lab test.
-|-
-Lab Test Results - Scenario 2: Local processing||LBORRES||R ||Result of the measurement or finding as originally received or collected.
-|-
-Lab Test Results - Scenario 2: Local processing||LBORRESU||R ||Original units in which the data were collected.
-|-
-Lab Test Results - Scenario 2: Local processing||"LBORNRLO
-LBORNRHI
-LBSTNRC
-"||R2||"Normal range for continuous measurements in original units.
-Normal values for non-continuous measurements in original units.
-"
-|-
-Lab Test Results - Scenario 2: Local processing||LBNRIND||R2||Reference Range Indicator Indicates where value falls with respect to reference range defined by high and low ranges.
-|-
-Lab Test Results - Scenario 2: Local processing||"LBCLSG
-(Note: If collected will be mapped to SUPPQUAL domain.)"||R2||Whether lab test results were clinically significant.
-|-
-Lab Test Results - Scenario 2: Local processing||LBNAM||R2||Name of lab analyzing sample.
-|-
-Lab Test Results - Scenario 2: Local processing||LBREFID||R2||Internal or external specimen identifier.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBDTC||R ||Date of sample collection.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||"LBTM
-(Note: If collected, will be derived into LBDTC.)"||R2||Time of collection.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBSTAT||R ||Status of whether or not lab was done.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||"LBCAT
-LBSCAT
-"||R2||Type of draw / category / panel name. Used to define a category of related records.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBTPT||R2||Relative time for use when multiple sequential assessments are done,
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBFAST (for example)||R2||Conditions for sampling defined in the protocol.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBTEST||R ||Verbatim name of the test or examination used to obtain the measurement or finding. Note: any test normally performed by a clinical laboratory is considered a lab test.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBORRES||R2||Result of the measurement or finding as originally received or collected.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||"LBCLSG
-(Note: If collected will be mapped to SUPPQUAL domain.)"||R ||Whether lab test results were clinically significant.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBNAM||R2||Name of lab analyzing sample.
-|-
-Lab Test Results - Scenario 3: Central processing but CRF includes site assessment…||LBREFID||R2||Internal or external specimen identifier.
-|-
-ECG Test Results - Scenario 1:  Central reading…||LBDTC||R||Date of sample collection.
-|-
-ECG Test Results - Scenario 1:  Central reading…||"LBTM
-(Note: If collected, will be derived into LBDTC.)"||O||Time of collection.
-|-
-ECG Test Results - Scenario 1:  Central reading…||SBSTAT||R||Status of whether or not lab was done.
-|-
-ECG Test Results - Scenario 1:  Central reading…||"LBCAT
-LBSCAT"||Recommended / Conditional||Type of draw / category / panel name. Used to define a category of related records.
-|-
-ECG Test Results - Scenario 1:  Central reading…||LBTPT||Recommended / Conditional||Relative time for use when multiple sequential assessments are done.
-|-
-ECG Test Results - Scenario 1:  Central reading…||LBFAST (for example)||O||Conditions for sampling defined in the protocol.
-|-
-ECG Test Results - Scenario 1:  Central reading…||LBREFID||O ||Internal or external specimen identifier.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGSTAT||R||Status of whether or not ECG was done.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGREASND||O ||Describes why the ECG was not done (e.g., BROKEN EQUIPMENT, SUBJECT REFUSED).
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGDTC||R||Date of ECG.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||"EGTM
-(Note: If collected, will be derived into EGDTC.)"||Recommended / Conditional||Time of ECG.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGTPT||Recommended / Conditional||Text description of planned time point when measurements should be taken  for use when multiple sequential assessments are done
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||"EGTESTCD
-And/or
-EGTEST"||R||Verbatim name of the test or examination used to obtain the measurement or finding.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGORRES||R||Result of the measurement or finding as originally received or collected.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGORRESU||Recommended / Conditional||Original units in which the data were collected.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||"EGCLSG
-(Note: If collected will be mapped to SUPPQUAL domain.)"||O||Whether ECG results were clinically significant.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGPOS, EGMETHOD (for example)||O ||Condition for testing defined in the protocol.
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGEVAL||O||Role of the person who provided the evaluation.  This should only be used for results that are subjective (e.g., assigned by a person or a group) and do not apply to quantitative results (i.e. ADJUDICATION COMMITTEE, INVESTIGATOR).
-|-
-ECG Test Results - Scenario 2:  Local reading: ECGs…||EGREFID||O ||Internal or external identifier.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGSTAT||R||Status of whether or not ECG was done.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGREASND||O ||Describes why the ECG was not done (e.g., BROKEN EQUIPMENT, SUBJECT REFUSED).
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGDTC||R||Date of ECG.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||"EGTM
-(Note: If collected, will be derived into EGDTC.)"||Recommended / Conditional||Time of ECG.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGTPT||Recommended / Conditional||Text description of planned time point when measurements should be taken  for use when multiple sequential assessments are done.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGTEST||R||Verbatim name of the test or examination used to obtain the measurement or finding.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGORRESU||Recommended / Conditional||Original units in which the data were collected.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||"EGCLSG
-(Note: If collected, will be mapped to SUPPQUAL domain.)"||R||Whether ECG results were clinically significant.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGORRES||Recommended / Conditional||Result of the measurement or finding as originally received or collected.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGORRESU||Recommended / Conditional||Original units in which the data were collected.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGNAM||Recommended / Conditional||Name of vendor  providing ECG data.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGPOS, EGMETHOD (for example)||O||Conditions for testing defined in the protocol.
-|-
-ECG Test Results - Scenario 3:  Central reading (as in Scenario 1): But…||EGREFID||O ||Internal or external ECG identifier.
 |}

Difference between revisions of "Clinical Research Data Capture - (CRD)"

Revision as of 14:03, 22 May 2008

Introduction

Profile Abstract

Glossary

Volume I

Dependencies

Profile Name

Use Case

Current State

Desired State

Actors/Transaction

Grouping

Content Bindings with RFD

Options

Form Filler Options

CCD Option

CDASH Option

Form Manager Options

CCD Option

CDASH Option

Process Flow

Actor Definitions

Transaction Definitions

Volume II

Clinical Research Data Capture Content

Standards

Data Element Index

Document Specification

Header Sample

Active Problems Sample (1.3.6.1.4.1.19376.1.5.3.1.3.6)

Past Medical History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.8)

Procedures and Interventions Sample (1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11)

Social History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.16)

Current Medications Sample (1.3.6.1.4.1.19376.1.5.3.1.3.19)

Vital Signs Sample (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2)

Physical Exam Sample (1.3.6.1.4.1.19376.1.5.3.1.1.9.15)

Allergies and Other Adverse Reactions Sample (1.3.6.1.4.1.19376.1.5.3.1.3.13)

Coded Results Sample (1.3.6.1.4.1.19376.1.5.3.1.3.28)

Reference Implementation

Clinical Research CCD to Standard CRF (ODM/CDASH) Crosswalk

XSLT Sample

Sample Standard CRF output from the Sample XSLT

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