Free-text Allergy to clinical trial drug

generate permalink back to homepage

Approval Status

  • Approval Status: Approved
  • Example Task Force: 4/26/2018
  • SDWG: 10/1/2018

C-CDA 2.1 Example:

  • 2.16.840.1.113883.10.20.22.2.6.1:2015-08-01

  • Allergy Concern Act 2.16.840.1.113883.10.20.22.4.30:2015-08-01

  • Allergy Intolerance Observation 2.16.840.1.113883.10.20.22.4.7:2014-06-09

  • Reaction Observation 2.16.840.1.113883.10.20.22.4.9:2014-06-09
  • Severity Observation 2.16.840.1.113883.10.20.22.4.8:2014-06-09

Reference to full CDA sample:

  • Allergies in empty CCD

Validation location

Comments

  • This example illustrates an example of allergy to a new drug ingredient which is in a clinical trial phase and not approved by the FDA. As a result, there is no RxNorm, NDF-RT, SNOMED or UNII code. An NCI thesaurus code is in turn used as a translation code since NCI tracks new chemotherapy drugs in clinical trial phases.

Additional Notes and Assumptions: * The example drug, talazoparib, was in clinical trial phase at the time of this example. It is possible for this drug to be approved at some point in the future after this C-CDA example is approved.

Custodian

  • May Terry (GitHub: mayterry88)

Keywords

  • substance, allergies, allergy

 

Example: download example view on GitHub

<?xml version="1.0" encoding="UTF-8"?>
<section>
    <templateId root="2.16.840.1.113883.10.20.22.2.6.1"/>
    <templateId root="2.16.840.1.113883.10.20.22.2.6.1" extension="2015-08-01"/>
    <!-- Allergies (entries required) section template -->
    <code code="48765-2" codeSystem="2.16.840.1.113883.6.1"/>
    <title>Allergies, Adverse Reactions and Alerts</title>
    <text>
        <table>
            <thead>
                <tr>
                    <th>Allergen</th>
                    <th>Reaction</th>
                    <th>Reaction Severity</th>
                    <th>Documentation Date</th>
                    <th>Onset Date</th> <!-- Date from observation/effectiveTime-->
                </tr>
            </thead>
            <tbody>
                <tr ID="allergy1">
                    <td ID="allergy1allergen">talazoparib</td>
                    <td>
                        <content ID="allergy1reaction">Dyspnea</content>
                    </td>
                    <td>
                        <content ID="allergy1reactionseverity">Moderate</content>
                    </td>
                    <td>April 1 2018</td>
                    <td>April 1 2018</td>
                </tr>
            </tbody>
        </table>
    </text>
    <entry typeCode="DRIV">
        <act classCode="ACT" moodCode="EVN">
            <!-- ** Allergy problem act ** -->
            <templateId root="2.16.840.1.113883.10.20.22.4.30"/>
            <templateId root="2.16.840.1.113883.10.20.22.4.30" extension="2015-08-01"/>
            <id root="4a2ac5fc-0c85-4223-baee-c2e254803974"/>
            <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>
            <text>
			  <reference value="allergy1"/>
			</text
            <statusCode code="active"/>
            <!-- This is the time stamp for when the allergy was first documented as a concern-->
            <effectiveTime value="20180401103001-0500"/> <!-- Apr 1, 2018 at 10:30a ET -->
            <author>
                <templateId root="2.16.840.1.113883.10.20.22.4.119"/>
                <time value="20180401"/>
                <assignedAuthor>
                    <id extension="12345" root="2.16.840.1.113883.4.6"/>
                    <code code="207RX0202X" codeSystem="2.16.840.1.113883.6.101"
                        codeSystemName="Health Care Provider Taxonomy" displayName="Medical Oncology"/>
                    <telecom use="WP" value="tel:555-555-1234"/>
                    <assignedPerson>
                        <name>
                            <given>Adam</given>
                            <family>Anydoc</family>
                        </name>
                    </assignedPerson>
                </assignedAuthor>
            </author>
            <entryRelationship typeCode="SUBJ">
                <observation classCode="OBS" moodCode="EVN">
                    <!-- allergy observation template -->
                    <templateId root="2.16.840.1.113883.10.20.22.4.7"/>
                    <templateId root="2.16.840.1.113883.10.20.22.4.7" extension="2014-06-09"/>
                    <id root="4d3ac7ac-0c32-8712-b3fe-c2b268808259"/>
                    <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
                    <statusCode code="completed"/>
                    <!-- This is the time stamp for the biological onset of the allergy. -->
                    <!-- Just the year is shown since a specific month and date was not reported -->
                    <effectiveTime>
                        <low value="20180401"/>
                        <high value="20180401"/>
                    </effectiveTime>
                    <!-- This specifies that the allergy is to a medication in contrast to other allergies (substance) -->
                    <value xsi:type="CD" code="59037007" displayName="Drug intolerance (disorder)"
                        codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" />
                    <author>
                        <templateId root="2.16.840.1.113883.10.20.22.4.119"/>
                        <time value="20180401"/>
                        <assignedAuthor>
                            <id extension="99999999" root="2.16.840.1.113883.4.6"/>
                            <code code="207RX0202X" codeSystem="2.16.840.1.113883.6.101"
                                codeSystemName="Health Care Provider Taxonomy"
                                displayName="Medical Oncology"/>
                            <telecom use="WP" value="tel:555-555-1234"/>
                            <assignedPerson>
                                <name>
                                    <given>Adam</given>
                                    <family>Anydoc</family>
                                </name>
                            </assignedPerson>
                        </assignedAuthor>
                    </author>
                    <participant typeCode="CSM">
                        <participantRole classCode="MANU">
                            <playingEntity classCode="MMAT">
                                <!-- This drug is a clinical trial drug not approved by FDA so there is no RxNorm code -->
                                <!-- For non-drug substances that don't have a concept you may omit codeSystem -->
                                <!-- Use OTH and originalText -->
                                <code nullFlavor="OTH" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm"> 
                                    <originalText>
                                        <reference value="#allergy1allergen"/>
                                    </originalText>
                                    <!-- Include clinical trial code or local code and codeSystem in translation-->
                                   <translation code="C95733" displayName="talazoparib" 
                                                codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI"/>
                                </code>
                            </playingEntity>
                        </participantRole>
                    </participant>
                    <!-- Only one reaction recorded here, although multiple reactions may be recorded to the same substance ([0..*] -->
                    <entryRelationship typeCode="MFST" inversionInd="true">
                        <observation classCode="OBS" moodCode="EVN">
                            <!-- Reaction Observation template -->
                            <templateId root="2.16.840.1.113883.10.20.22.4.9"/>
                            <templateId root="2.16.840.1.113883.10.20.22.4.9" extension="2014-06-09"/>
                            <id root="fea0b775-f3fe-4e0a-9c4f-4a5c235c2af0"/>
                            <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
                            
                            <statusCode code="completed"/>
                            <effectiveTime value = "20180401"/>
                            <value xsi:type="CD" code="267036007" codeSystem="2.16.840.1.113883.6.96"
                                codeSystemName="SNOMED CT" displayName="Dyspnea">
                                <originalText>
                                    <reference value="#allergy1reaction"/>
                                </originalText>
                            </value>
                            <entryRelationship typeCode="SUBJ" inversionInd="true">
                                <observation classCode="OBS" moodCode="EVN">
                                    <!-- Severity Observation template -->
                                    <templateId root="2.16.840.1.113883.10.20.22.4.8"/>
                                    <templateId root="2.16.840.1.113883.10.20.22.4.8" extension="2014-06-09"/>
                                    <code code="SEV" codeSystem="2.16.840.1.113883.5.4"
                                        codeSystemName="ActCode"/>
                                    <text>
                                        <reference value="#allergy1reactionseverity"/>
                                    </text>
                                    <statusCode code="completed"/>
                                    <value xsi:type="CD" code="6736007" codeSystem="2.16.840.1.113883.6.96"
                                        codeSystemName="SNOMED CT" displayName="Moderate"/>
                                </observation>
                            </entryRelationship>
                        </observation>
                    </entryRelationship>
                   </observation>
            </entryRelationship>
        </act>
    </entry>
</section>
  1. C-CDA Example Search Help

    C-CDA Example Search Results
    This screen displays the results of executing the example search criteria against the existing examples recorded in the example database.

  2. Search Criteria Panel

    This panel allow you to further refine your queries and narrow the results

  3. Text Search Words

    Use this field to enter words related to your search. These words can appear in the title, the comments or as part of a special list of keywords associated with the example. The search words should be entered with spaces separating the items.

  4. Filter by example status

    By selecting the various statuses, the search results can be limited to only the example that are set to the selected status(es). By removing all status selections, the filtering is removed and examples from all statuses will be returned (based on any other filtering).

  5. Select only ONC Certified examples

    These are samples referenced in a government rule or certification companion guide.

  6. Execute the search based on the criteria entered (or retrieve all examples if no criteria specified).

  7. The number of results that match the query parameters can be found here.

  8. Use this link to jump back to the initial page of the application (that lists the sections).

  9. This columns list the names of the examples that match the criteria (and the comment for each example).

  10. This columns lists the area in the C-CDA specification (the specification is broken into distinct topics for the various exchangeable documents, the common header, and the sections that occur within the exchangeable documents) that the example demonstrates.

  11. This columns lists the state of the example in the example verification and approval process.

  12. You can select to download the examples directly or navigate to page with the full detailed description of the example.

  13. Tour Complete

    Return to the C-CDA Example Search Results page.