This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

• Narrative Content
• XML
• JSON
• TTL

: Temporary Codes - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:CodeSystem;
  fhir:nodeRole fhir:treeRoot;
  fhir:Resource.id [ fhir:value "temporarycodes"];
  fhir:Resource.meta [
     fhir:Meta.versionId [ fhir:value "14" ];
     fhir:Meta.lastUpdated [ fhir:value "2021-07-28T19:57:43.738+00:00"^^xsd:dateTime ];
     fhir:Meta.source [ fhir:value "#zromzYz4qd2dRhUi" ];
     fhir:Meta.profile [
       fhir:value "http://hl7.org/fhir/StructureDefinition/shareablecodesystem";
       fhir:index 0;
       fhir:link <http://hl7.org/fhir/StructureDefinition/shareablecodesystem>     ]
  ];
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">INITIAL<a name=\"temporarycodes-INITIAL\"> </a></td><td>Initial</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">UPDATE<a name=\"temporarycodes-UPDATE\"> </a></td><td>Update</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">INT<a name=\"temporarycodes-INT\"> </a></td><td>Interventional</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">OBS<a name=\"temporarycodes-OBS\"> </a></td><td>Observational</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">APPROVED<a name=\"temporarycodes-APPROVED\"> </a></td><td>Approved for reliance</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">POSSIBLE<a name=\"temporarycodes-POSSIBLE\"> </a></td><td>Potential/possible</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">CANCELLED<a name=\"temporarycodes-CANCELLED\"> </a></td><td>Cancelled or not participating</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">ONHOLD<a name=\"temporarycodes-ONHOLD\"> </a></td><td>Temporarily on hold</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">DENIED<a name=\"temporarycodes-DENIED\"> </a></td><td>Denied reliance</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">SFS<a name=\"temporarycodes-SFS\"> </a></td><td>Sponsor or Funding Source</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">CRO<a name=\"temporarycodes-CRO\"> </a></td><td>Contract Research Organization (CRO)</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">AR<a name=\"temporarycodes-AR\"> </a></td><td>Accepts Review</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">DR<a name=\"temporarycodes-DR\"> </a></td><td>Denies Review</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">sIRB<a name=\"temporarycodes-sIRB\"> </a></td><td>sIRB (Reviewing Site)</td><td>Site is the sIRB</td></tr><tr><td style=\"white-space:nowrap\">Relying<a name=\"temporarycodes-Relying\"> </a></td><td>Relying Site</td><td>Site is the Relying Site</td></tr><tr><td style=\"white-space:nowrap\">VM<a name=\"temporarycodes-VM\"> </a></td><td>Telephone and voice messages</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">VC<a name=\"temporarycodes-VC\"> </a></td><td>Video Conferencing</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">EMAIL<a name=\"temporarycodes-EMAIL\"> </a></td><td>Email</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">TXT<a name=\"temporarycodes-TXT\"> </a></td><td>Text messages/texting</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">EHPRTL<a name=\"temporarycodes-EHPRTL\"> </a></td><td>eHealth Portal messaging</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">SA<a name=\"temporarycodes-SA\"> </a></td><td>Study Agent</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">PLACEBO<a name=\"temporarycodes-PLACEBO\"> </a></td><td>Placebo</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">BSA<a name=\"temporarycodes-BSA\"> </a></td><td>Blinded Study Agent</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">PRMYDIS<a name=\"temporarycodes-PRMYDIS\"> </a></td><td>Primary disease</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">STDYPRO<a name=\"temporarycodes-STDYPRO\"> </a></td><td>Study Procedure</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">PRE<a name=\"temporarycodes-PRE\"> </a></td><td>Pre-existing condition</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">UNDERLYINGDIS<a name=\"temporarycodes-UNDERLYINGDIS\"> </a></td><td>Underlying disease</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">CONCMITMED<a name=\"temporarycodes-CONCMITMED\"> </a></td><td>Concomitant medication</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">OTHERCAUSE<a name=\"temporarycodes-OTHERCAUSE\"> </a></td><td>Other known or suspected cause</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">nochange<a name=\"temporarycodes-nochange\"> </a></td><td>No change in research activities</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">stopped<a name=\"temporarycodes-stopped\"> </a></td><td>All research activities temporarily and voluntarily stopped for all participants</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">partial<a name=\"temporarycodes-partial\"> </a></td><td>Partial voluntary hold on some research activities for all participants (explain below)</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">hold<a name=\"temporarycodes-hold\"> </a></td><td>Voluntary hold on new participant enrollment only</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">init<a name=\"temporarycodes-init\"> </a></td><td>Initial</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">followup<a name=\"temporarycodes-followup\"> </a></td><td>Follow-up</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">completed<a name=\"temporarycodes-completed\"> </a></td><td>Done, performed or completed</td><td>The action was done, performed or completed</td></tr><tr><td style=\"white-space:nowrap\">pending<a name=\"temporarycodes-pending\"> </a></td><td>Pending - Currently under development</td><td>The action is in progress or status is pending</td></tr><tr><td style=\"white-space:nowrap\">notundertaken<a name=\"temporarycodes-notundertaken\"> </a></td><td>Not done or undertaken</td><td>The action was not started and is not in progress</td></tr><tr><td style=\"white-space:nowrap\">mla<a name=\"temporarycodes-mla\"> </a></td><td>Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">mtd<a name=\"temporarycodes-mtd\"> </a></td><td>Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">otherreason<a name=\"temporarycodes-otherreason\"> </a></td><td>Other reason</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">open<a name=\"temporarycodes-open\"> </a></td><td>Open for enrollment</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">closed<a name=\"temporarycodes-closed\"> </a></td><td>Closed to enrollment</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">not-open<a name=\"temporarycodes-not-open\"> </a></td><td>Not yet open</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">open-no-participants<a name=\"temporarycodes-open-no-participants\"> </a></td><td>Open with no participants</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">complete<a name=\"temporarycodes-complete\"> </a></td><td>All interventions complete</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">continue-intvnt<a name=\"temporarycodes-continue-intvnt\"> </a></td><td>Continuing interventions</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">continue-min-risk<a name=\"temporarycodes-continue-min-risk\"> </a></td><td>Continuing interventions - minimal risk</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">federal<a name=\"temporarycodes-federal\"> </a></td><td>Federal</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">state<a name=\"temporarycodes-state\"> </a></td><td>State</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">industry<a name=\"temporarycodes-industry\"> </a></td><td>Industry</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">foundation<a name=\"temporarycodes-foundation\"> </a></td><td>Foundation</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">institutional<a name=\"temporarycodes-institutional\"> </a></td><td>Institutional</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">departmental<a name=\"temporarycodes-departmental\"> </a></td><td>Departmental</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">otherfund<a name=\"temporarycodes-otherfund\"> </a></td><td>Other Funding Source</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">Other<a name=\"temporarycodes-Other\"> </a></td><td>Other</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">DBV<a name=\"temporarycodes-DBV\"> </a></td><td>Drug/Biologic/Vaccine</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">DEV<a name=\"temporarycodes-DEV\"> </a></td><td>Device</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">SBE<a name=\"temporarycodes-SBE\"> </a></td><td>Social/Behavioral/educational (SBE)</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">PRO<a name=\"temporarycodes-PRO\"> </a></td><td>Procedural</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">IND<a name=\"temporarycodes-IND\"> </a></td><td>IND</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">IDE<a name=\"temporarycodes-IDE\"> </a></td><td>IDE</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">COPI<a name=\"temporarycodes-COPI\"> </a></td><td>Co-Principal Investigator</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">COI<a name=\"temporarycodes-COI\"> </a></td><td>Co-Investigator</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">PD<a name=\"temporarycodes-PD\"> </a></td><td>Program Director</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">RES<a name=\"temporarycodes-RES\"> </a></td><td>Research</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">STDCR<a name=\"temporarycodes-STDCR\"> </a></td><td>Standard of Care</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">PHYS<a name=\"temporarycodes-PHYS\"> </a></td><td>Physical</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">NONPHYS<a name=\"temporarycodes-NONPHYS\"> </a></td><td>Non-Physical</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">TRTNOTCOV<a name=\"temporarycodes-TRTNOTCOV\"> </a></td><td>Treatment not covered</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">RRICOV<a name=\"temporarycodes-RRICOV\"> </a></td><td>Research Related injury covered</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">ACNOTCICOV<a name=\"temporarycodes-ACNOTCICOV\"> </a></td><td>Acute but not chronic injury covered</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">OTHINSTRES<a name=\"temporarycodes-OTHINSTRES\"> </a></td><td>Researchers at other institutions</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">THISINSTRES<a name=\"temporarycodes-THISINSTRES\"> </a></td><td>Researchers outside the study team at this institution</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">EXTREGAUTH<a name=\"temporarycodes-EXTREGAUTH\"> </a></td><td>External Regulatory Authorities</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">DEIDUSED<a name=\"temporarycodes-DEIDUSED\"> </a></td><td>Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">DEIDNOTUSED<a name=\"temporarycodes-DEIDNOTUSED\"> </a></td><td>Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.</td><td>TBD</td></tr><tr><td style=\"white-space:nowrap\">continue-meds<a name=\"temporarycodes-continue-meds\"> </a></td><td>Continuing interventions</td><td>TBD</td></tr></table></div>"
  ];
  fhir:CodeSystem.url [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"];
  fhir:CodeSystem.identifier [
     fhir:index 0;
     fhir:Identifier.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
     fhir:Identifier.value [ fhir:value "temporary-codes" ]
  ];
  fhir:CodeSystem.version [ fhir:value "0.1.0"];
  fhir:CodeSystem.name [ fhir:value "TemporaryCodes"];
  fhir:CodeSystem.title [ fhir:value "Temporary Codes"];
  fhir:CodeSystem.status [ fhir:value "draft"];
  fhir:CodeSystem.experimental [ fhir:value "true"^^xsd:boolean];
  fhir:CodeSystem.date [ fhir:value "2021-07-23"^^xsd:date];
  fhir:CodeSystem.publisher [ fhir:value "HL7 International - BR&R Work Group"];
  fhir:CodeSystem.contact [
     fhir:index 0;
     fhir:ContactDetail.name [ fhir:value "HL7 International - Biomedical Research and Regulation" ];
     fhir:ContactDetail.telecom [
       fhir:index 0;
       fhir:ContactPoint.system [ fhir:value "url" ];
       fhir:ContactPoint.value [ fhir:value "http://www.hl7.org/Special/committees/rcrim" ]     ]
  ];
  fhir:CodeSystem.description [ fhir:value "This is a temporary codesystem capturing the custom codelists used across the sIRB forms."];
  fhir:CodeSystem.jurisdiction [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
       fhir:Coding.code [ fhir:value "US" ];
       fhir:Coding.display [ fhir:value "United States of America" ]     ];
     fhir:CodeableConcept.text [ fhir:value "United States of America" ]
  ];
  fhir:CodeSystem.caseSensitive [ fhir:value "true"^^xsd:boolean];
  fhir:CodeSystem.content [ fhir:value "complete"];
  fhir:CodeSystem.concept [
     fhir:index 0;
     fhir:CodeSystem.concept.code [ fhir:value "INITIAL" ];
     fhir:CodeSystem.concept.display [ fhir:value "Initial" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 1;
     fhir:CodeSystem.concept.code [ fhir:value "UPDATE" ];
     fhir:CodeSystem.concept.display [ fhir:value "Update" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 2;
     fhir:CodeSystem.concept.code [ fhir:value "INT" ];
     fhir:CodeSystem.concept.display [ fhir:value "Interventional" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 3;
     fhir:CodeSystem.concept.code [ fhir:value "OBS" ];
     fhir:CodeSystem.concept.display [ fhir:value "Observational" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 4;
     fhir:CodeSystem.concept.code [ fhir:value "APPROVED" ];
     fhir:CodeSystem.concept.display [ fhir:value "Approved for reliance" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 5;
     fhir:CodeSystem.concept.code [ fhir:value "POSSIBLE" ];
     fhir:CodeSystem.concept.display [ fhir:value "Potential/possible" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 6;
     fhir:CodeSystem.concept.code [ fhir:value "CANCELLED" ];
     fhir:CodeSystem.concept.display [ fhir:value "Cancelled or not participating" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 7;
     fhir:CodeSystem.concept.code [ fhir:value "ONHOLD" ];
     fhir:CodeSystem.concept.display [ fhir:value "Temporarily on hold" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 8;
     fhir:CodeSystem.concept.code [ fhir:value "DENIED" ];
     fhir:CodeSystem.concept.display [ fhir:value "Denied reliance" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 9;
     fhir:CodeSystem.concept.code [ fhir:value "SFS" ];
     fhir:CodeSystem.concept.display [ fhir:value "Sponsor or Funding Source" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 10;
     fhir:CodeSystem.concept.code [ fhir:value "CRO" ];
     fhir:CodeSystem.concept.display [ fhir:value "Contract Research Organization (CRO)" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 11;
     fhir:CodeSystem.concept.code [ fhir:value "AR" ];
     fhir:CodeSystem.concept.display [ fhir:value "Accepts Review" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 12;
     fhir:CodeSystem.concept.code [ fhir:value "DR" ];
     fhir:CodeSystem.concept.display [ fhir:value "Denies Review" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 13;
     fhir:CodeSystem.concept.code [ fhir:value "sIRB" ];
     fhir:CodeSystem.concept.display [ fhir:value "sIRB (Reviewing Site)" ];
     fhir:CodeSystem.concept.definition [ fhir:value "Site is the sIRB" ]
  ], [
     fhir:index 14;
     fhir:CodeSystem.concept.code [ fhir:value "Relying" ];
     fhir:CodeSystem.concept.display [ fhir:value "Relying Site" ];
     fhir:CodeSystem.concept.definition [ fhir:value "Site is the Relying Site" ]
  ], [
     fhir:index 15;
     fhir:CodeSystem.concept.code [ fhir:value "VM" ];
     fhir:CodeSystem.concept.display [ fhir:value "Telephone and voice messages" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 16;
     fhir:CodeSystem.concept.code [ fhir:value "VC" ];
     fhir:CodeSystem.concept.display [ fhir:value "Video Conferencing" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 17;
     fhir:CodeSystem.concept.code [ fhir:value "EMAIL" ];
     fhir:CodeSystem.concept.display [ fhir:value "Email" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 18;
     fhir:CodeSystem.concept.code [ fhir:value "TXT" ];
     fhir:CodeSystem.concept.display [ fhir:value "Text messages/texting" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 19;
     fhir:CodeSystem.concept.code [ fhir:value "EHPRTL" ];
     fhir:CodeSystem.concept.display [ fhir:value "eHealth Portal messaging" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 20;
     fhir:CodeSystem.concept.code [ fhir:value "SA" ];
     fhir:CodeSystem.concept.display [ fhir:value "Study Agent" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 21;
     fhir:CodeSystem.concept.code [ fhir:value "PLACEBO" ];
     fhir:CodeSystem.concept.display [ fhir:value "Placebo" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 22;
     fhir:CodeSystem.concept.code [ fhir:value "BSA" ];
     fhir:CodeSystem.concept.display [ fhir:value "Blinded Study Agent" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 23;
     fhir:CodeSystem.concept.code [ fhir:value "PRMYDIS" ];
     fhir:CodeSystem.concept.display [ fhir:value "Primary disease" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 24;
     fhir:CodeSystem.concept.code [ fhir:value "STDYPRO" ];
     fhir:CodeSystem.concept.display [ fhir:value "Study Procedure" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 25;
     fhir:CodeSystem.concept.code [ fhir:value "PRE" ];
     fhir:CodeSystem.concept.display [ fhir:value "Pre-existing condition" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 26;
     fhir:CodeSystem.concept.code [ fhir:value "UNDERLYINGDIS" ];
     fhir:CodeSystem.concept.display [ fhir:value "Underlying disease" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 27;
     fhir:CodeSystem.concept.code [ fhir:value "CONCMITMED" ];
     fhir:CodeSystem.concept.display [ fhir:value "Concomitant medication" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 28;
     fhir:CodeSystem.concept.code [ fhir:value "OTHERCAUSE" ];
     fhir:CodeSystem.concept.display [ fhir:value "Other known or suspected cause" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 29;
     fhir:CodeSystem.concept.code [ fhir:value "nochange" ];
     fhir:CodeSystem.concept.display [ fhir:value "No change in research activities" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 30;
     fhir:CodeSystem.concept.code [ fhir:value "stopped" ];
     fhir:CodeSystem.concept.display [ fhir:value "All research activities temporarily and voluntarily stopped for all participants" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 31;
     fhir:CodeSystem.concept.code [ fhir:value "partial" ];
     fhir:CodeSystem.concept.display [ fhir:value "Partial voluntary hold on some research activities for all participants (explain below)" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 32;
     fhir:CodeSystem.concept.code [ fhir:value "hold" ];
     fhir:CodeSystem.concept.display [ fhir:value "Voluntary hold on new participant enrollment only" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 33;
     fhir:CodeSystem.concept.code [ fhir:value "init" ];
     fhir:CodeSystem.concept.display [ fhir:value "Initial" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 34;
     fhir:CodeSystem.concept.code [ fhir:value "followup" ];
     fhir:CodeSystem.concept.display [ fhir:value "Follow-up" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 35;
     fhir:CodeSystem.concept.code [ fhir:value "completed" ];
     fhir:CodeSystem.concept.display [ fhir:value "Done, performed or completed" ];
     fhir:CodeSystem.concept.definition [ fhir:value "The action was done, performed or completed" ]
  ], [
     fhir:index 36;
     fhir:CodeSystem.concept.code [ fhir:value "pending" ];
     fhir:CodeSystem.concept.display [ fhir:value "Pending - Currently under development" ];
     fhir:CodeSystem.concept.definition [ fhir:value "The action is in progress or status is pending" ]
  ], [
     fhir:index 37;
     fhir:CodeSystem.concept.code [ fhir:value "notundertaken" ];
     fhir:CodeSystem.concept.display [ fhir:value "Not done or undertaken" ];
     fhir:CodeSystem.concept.definition [ fhir:value "The action was not started and is not in progress" ]
  ], [
     fhir:index 38;
     fhir:CodeSystem.concept.code [ fhir:value "mla" ];
     fhir:CodeSystem.concept.display [ fhir:value "Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 39;
     fhir:CodeSystem.concept.code [ fhir:value "mtd" ];
     fhir:CodeSystem.concept.display [ fhir:value "Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 40;
     fhir:CodeSystem.concept.code [ fhir:value "otherreason" ];
     fhir:CodeSystem.concept.display [ fhir:value "Other reason" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 41;
     fhir:CodeSystem.concept.code [ fhir:value "open" ];
     fhir:CodeSystem.concept.display [ fhir:value "Open for enrollment" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 42;
     fhir:CodeSystem.concept.code [ fhir:value "closed" ];
     fhir:CodeSystem.concept.display [ fhir:value "Closed to enrollment" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 43;
     fhir:CodeSystem.concept.code [ fhir:value "not-open" ];
     fhir:CodeSystem.concept.display [ fhir:value "Not yet open" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 44;
     fhir:CodeSystem.concept.code [ fhir:value "open-no-participants" ];
     fhir:CodeSystem.concept.display [ fhir:value "Open with no participants" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 45;
     fhir:CodeSystem.concept.code [ fhir:value "complete" ];
     fhir:CodeSystem.concept.display [ fhir:value "All interventions complete" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 46;
     fhir:CodeSystem.concept.code [ fhir:value "continue-intvnt" ];
     fhir:CodeSystem.concept.display [ fhir:value "Continuing interventions" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 47;
     fhir:CodeSystem.concept.code [ fhir:value "continue-min-risk" ];
     fhir:CodeSystem.concept.display [ fhir:value "Continuing interventions - minimal risk" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 48;
     fhir:CodeSystem.concept.code [ fhir:value "federal" ];
     fhir:CodeSystem.concept.display [ fhir:value "Federal" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 49;
     fhir:CodeSystem.concept.code [ fhir:value "state" ];
     fhir:CodeSystem.concept.display [ fhir:value "State" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 50;
     fhir:CodeSystem.concept.code [ fhir:value "industry" ];
     fhir:CodeSystem.concept.display [ fhir:value "Industry" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 51;
     fhir:CodeSystem.concept.code [ fhir:value "foundation" ];
     fhir:CodeSystem.concept.display [ fhir:value "Foundation" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 52;
     fhir:CodeSystem.concept.code [ fhir:value "institutional" ];
     fhir:CodeSystem.concept.display [ fhir:value "Institutional" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 53;
     fhir:CodeSystem.concept.code [ fhir:value "departmental" ];
     fhir:CodeSystem.concept.display [ fhir:value "Departmental" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 54;
     fhir:CodeSystem.concept.code [ fhir:value "otherfund" ];
     fhir:CodeSystem.concept.display [ fhir:value "Other Funding Source" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 55;
     fhir:CodeSystem.concept.code [ fhir:value "Other" ];
     fhir:CodeSystem.concept.display [ fhir:value "Other" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 56;
     fhir:CodeSystem.concept.code [ fhir:value "DBV" ];
     fhir:CodeSystem.concept.display [ fhir:value "Drug/Biologic/Vaccine" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 57;
     fhir:CodeSystem.concept.code [ fhir:value "DEV" ];
     fhir:CodeSystem.concept.display [ fhir:value "Device" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 58;
     fhir:CodeSystem.concept.code [ fhir:value "SBE" ];
     fhir:CodeSystem.concept.display [ fhir:value "Social/Behavioral/educational (SBE)" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 59;
     fhir:CodeSystem.concept.code [ fhir:value "PRO" ];
     fhir:CodeSystem.concept.display [ fhir:value "Procedural" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 60;
     fhir:CodeSystem.concept.code [ fhir:value "IND" ];
     fhir:CodeSystem.concept.display [ fhir:value "IND" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 61;
     fhir:CodeSystem.concept.code [ fhir:value "IDE" ];
     fhir:CodeSystem.concept.display [ fhir:value "IDE" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 62;
     fhir:CodeSystem.concept.code [ fhir:value "COPI" ];
     fhir:CodeSystem.concept.display [ fhir:value "Co-Principal Investigator" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 63;
     fhir:CodeSystem.concept.code [ fhir:value "COI" ];
     fhir:CodeSystem.concept.display [ fhir:value "Co-Investigator" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 64;
     fhir:CodeSystem.concept.code [ fhir:value "PD" ];
     fhir:CodeSystem.concept.display [ fhir:value "Program Director" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 65;
     fhir:CodeSystem.concept.code [ fhir:value "RES" ];
     fhir:CodeSystem.concept.display [ fhir:value "Research" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 66;
     fhir:CodeSystem.concept.code [ fhir:value "STDCR" ];
     fhir:CodeSystem.concept.display [ fhir:value "Standard of Care" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 67;
     fhir:CodeSystem.concept.code [ fhir:value "PHYS" ];
     fhir:CodeSystem.concept.display [ fhir:value "Physical" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 68;
     fhir:CodeSystem.concept.code [ fhir:value "NONPHYS" ];
     fhir:CodeSystem.concept.display [ fhir:value "Non-Physical" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 69;
     fhir:CodeSystem.concept.code [ fhir:value "TRTNOTCOV" ];
     fhir:CodeSystem.concept.display [ fhir:value "Treatment not covered" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 70;
     fhir:CodeSystem.concept.code [ fhir:value "RRICOV" ];
     fhir:CodeSystem.concept.display [ fhir:value "Research Related injury covered" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 71;
     fhir:CodeSystem.concept.code [ fhir:value "ACNOTCICOV" ];
     fhir:CodeSystem.concept.display [ fhir:value "Acute but not chronic injury covered" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 72;
     fhir:CodeSystem.concept.code [ fhir:value "OTHINSTRES" ];
     fhir:CodeSystem.concept.display [ fhir:value "Researchers at other institutions" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 73;
     fhir:CodeSystem.concept.code [ fhir:value "THISINSTRES" ];
     fhir:CodeSystem.concept.display [ fhir:value "Researchers outside the study team at this institution" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 74;
     fhir:CodeSystem.concept.code [ fhir:value "EXTREGAUTH" ];
     fhir:CodeSystem.concept.display [ fhir:value "External Regulatory Authorities" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 75;
     fhir:CodeSystem.concept.code [ fhir:value "DEIDUSED" ];
     fhir:CodeSystem.concept.display [ fhir:value "Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent." ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 76;
     fhir:CodeSystem.concept.code [ fhir:value "DEIDNOTUSED" ];
     fhir:CodeSystem.concept.display [ fhir:value "Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified." ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ], [
     fhir:index 77;
     fhir:CodeSystem.concept.code [ fhir:value "continue-meds" ];
     fhir:CodeSystem.concept.display [ fhir:value "Continuing interventions" ];
     fhir:CodeSystem.concept.definition [ fhir:value "TBD" ]
  ].

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.