Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## : Temporary Codes - XML Representation

Draft as of 2021-07-23

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    <CodeSystem xmlns="http://hl7.org/fhir">
      <id value="temporarycodes"/>
      <meta>
        <versionId value="25"/>
        <lastUpdated value="2022-03-01T05:48:06.916+00:00"/>
        <source value="#xB060rjIVhkfCGdb"/>
        <profile
                 value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/>
      </meta>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p>This code system <code>http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</code> 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">PHONECALL<a name="temporarycodes-PHONECALL"> </a></td><td>Telephone calls</td><td>TBD</td></tr><tr><td style="white-space:nowrap">VM<a name="temporarycodes-VM"> </a></td><td>Voice mail and telephone 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-meds<a name="temporarycodes-continue-meds"> </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">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">sourceQuestionnaireResponse<a name="temporarycodes-sourceQuestionnaireResponse"> </a></td><td>The content of the Questionnaire Response transferred to this Questionnaire during form launch</td><td>The content of the Questionnaire Response transferred to this Questionnaire during form launch</td></tr><tr><td style="white-space:nowrap">ResultsInDeath<a name="temporarycodes-ResultsInDeath"> </a></td><td>Results in death</td><td>Results in death</td></tr><tr><td style="white-space:nowrap">IsLifeThreatening<a name="temporarycodes-IsLifeThreatening"> </a></td><td>Is Life-threatening</td><td>Is Life-threatening</td></tr><tr><td style="white-space:nowrap">ResultsInHospitalization<a name="temporarycodes-ResultsInHospitalization"> </a></td><td>Requires or prolongs inpatient hospitalization</td><td>Requires or prolongs inpatient hospitalization</td></tr><tr><td style="white-space:nowrap">IsBirthDefect<a name="temporarycodes-IsBirthDefect"> </a></td><td>Is a congenital anomaly/birth defect</td><td>Is a congenital anomaly/birth defect</td></tr><tr><td style="white-space:nowrap">ResultsInDisability<a name="temporarycodes-ResultsInDisability"> </a></td><td>Results in persistent or significant disability/incapacity</td><td>Results in persistent or significant disability/incapacity</td></tr><tr><td style="white-space:nowrap">RequiresPreventImpairment<a name="temporarycodes-RequiresPreventImpairment"> </a></td><td>Requires intervention to prevent permanent impairment</td><td>Requires intervention to prevent permanent impairment</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">RCVRED<a name="temporarycodes-RCVRED"> </a></td><td>Recovered/Resolved</td><td>Recovered/Resolved</td></tr><tr><td style="white-space:nowrap">RCVRING<a name="temporarycodes-RCVRING"> </a></td><td>Recovering/Resolving</td><td>Recovering/Resolving</td></tr><tr><td style="white-space:nowrap">NRCVRED<a name="temporarycodes-NRCVRED"> </a></td><td>Not recovered/Not resolved/Ongoing</td><td>Not recovered/Not resolved/Ongoing</td></tr><tr><td style="white-space:nowrap">SEQL<a name="temporarycodes-SEQL"> </a></td><td>Recovered/Resolved with sequelae</td><td>Recovered/Resolved with sequelae</td></tr><tr><td style="white-space:nowrap">FATAL<a name="temporarycodes-FATAL"> </a></td><td>Fatal</td><td>Fatal</td></tr><tr><td style="white-space:nowrap">UNK<a name="temporarycodes-UNK"> </a></td><td>Unknown</td><td>Unknown</td></tr><tr><td style="white-space:nowrap">NC<a name="temporarycodes-NC"> </a></td><td>Product dose or frequency of use not changed</td><td>Product dose or frequency of use not changed</td></tr><tr><td style="white-space:nowrap">NA<a name="temporarycodes-NA"> </a></td><td>Not applicable</td><td>Not applicable</td></tr><tr><td style="white-space:nowrap">PreviousAccrual<a name="temporarycodes-PreviousAccrual"> </a></td><td>Previous Accrual</td><td>Previous Accrual</td></tr><tr><td style="white-space:nowrap">AdditionalEnrollees<a name="temporarycodes-AdditionalEnrollees"> </a></td><td>Additional enrollees this approval period</td><td>Additional enrollees this approval period</td></tr></table></div>
      </text>
      <url value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
      <identifier>
        <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
        <value value="temporary-codes"/>
      </identifier>
      <version value="1.0.0"/>
      <name value="TemporaryCodes"/>
      <title value="Temporary Codes"/>
      <status value="draft"/>
      <experimental value="true"/>
      <date value="2021-07-23"/>
      <publisher value="HL7 International - BR&amp;R Work Group"/>
      <contact>
        <name value="HL7 International - Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
      </contact>
      <description
                   value="This is a temporary codesystem capturing the custom codelists used across the sIRB forms."/>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="US"/>
          <display value="United States of America"/>
        </coding>
        <text value="United States of America"/>
      </jurisdiction>
      <caseSensitive value="true"/>
      <content value="complete"/>
      <concept>
        <code value="INITIAL"/>
        <display value="Initial"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="UPDATE"/>
        <display value="Update"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="INT"/>
        <display value="Interventional"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="OBS"/>
        <display value="Observational"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="APPROVED"/>
        <display value="Approved for reliance"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="POSSIBLE"/>
        <display value="Potential/possible"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="CANCELLED"/>
        <display value="Cancelled or not participating"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="ONHOLD"/>
        <display value="Temporarily on hold"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="DENIED"/>
        <display value="Denied reliance"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="SFS"/>
        <display value="Sponsor or Funding Source"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="CRO"/>
        <display value="Contract Research Organization (CRO)"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="AR"/>
        <display value="Accepts Review"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="DR"/>
        <display value="Denies Review"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PHONECALL"/>
        <display value="Telephone calls"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="VM"/>
        <display value="Voice mail and telephone voice messages"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="VC"/>
        <display value="Video Conferencing"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="EMAIL"/>
        <display value="Email"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="TXT"/>
        <display value="Text messages/texting"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="EHPRTL"/>
        <display value="eHealth Portal messaging"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="SA"/>
        <display value="Study Agent"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PLACEBO"/>
        <display value="Placebo"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="BSA"/>
        <display value="Blinded Study Agent"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PRMYDIS"/>
        <display value="Primary disease"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="STDYPRO"/>
        <display value="Study Procedure"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PRE"/>
        <display value="Pre-existing condition"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="UNDERLYINGDIS"/>
        <display value="Underlying disease"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="CONCMITMED"/>
        <display value="Concomitant medication"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="OTHERCAUSE"/>
        <display value="Other known or suspected cause"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="nochange"/>
        <display value="No change in research activities"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="stopped"/>
        <display
                 value="All research activities temporarily and voluntarily stopped for all participants"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="partial"/>
        <display
                 value="Partial voluntary hold on some research activities for all participants (explain below)"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="hold"/>
        <display value="Voluntary hold on new participant enrollment only"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="init"/>
        <display value="Initial"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="followup"/>
        <display value="Follow-up"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="completed"/>
        <display value="Done, performed or completed"/>
        <definition value="The action was done, performed or completed"/>
      </concept>
      <concept>
        <code value="pending"/>
        <display value="Pending - Currently under development"/>
        <definition value="The action is in progress or status is pending"/>
      </concept>
      <concept>
        <code value="notundertaken"/>
        <display value="Not done or undertaken"/>
        <definition value="The action was not started and is not in progress"/>
      </concept>
      <concept>
        <code value="mla"/>
        <display
                 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)"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="mtd"/>
        <display
                 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"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="otherreason"/>
        <display value="Other reason"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="open"/>
        <display value="Open for enrollment"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="closed"/>
        <display value="Closed to enrollment"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="not-open"/>
        <display value="Not yet open"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="open-no-participants"/>
        <display value="Open with no participants"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="complete"/>
        <display value="All interventions complete"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="continue-meds"/>
        <display value="Continuing interventions"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="continue-min-risk"/>
        <display value="Continuing interventions - minimal risk"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="federal"/>
        <display value="Federal"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="state"/>
        <display value="State"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="industry"/>
        <display value="Industry"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="foundation"/>
        <display value="Foundation"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="institutional"/>
        <display value="Institutional"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="departmental"/>
        <display value="Departmental"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="otherfund"/>
        <display value="Other Funding Source"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="DBV"/>
        <display value="Drug/Biologic/Vaccine"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="DEV"/>
        <display value="Device"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="SBE"/>
        <display value="Social/Behavioral/educational (SBE)"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PRO"/>
        <display value="Procedural"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="IND"/>
        <display value="IND"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="IDE"/>
        <display value="IDE"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="COPI"/>
        <display value="Co-Principal Investigator"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="COI"/>
        <display value="Co-Investigator"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PD"/>
        <display value="Program Director"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="RES"/>
        <display value="Research"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="STDCR"/>
        <display value="Standard of Care"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="PHYS"/>
        <display value="Physical"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="NONPHYS"/>
        <display value="Non-Physical"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="TRTNOTCOV"/>
        <display value="Treatment not covered"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="RRICOV"/>
        <display value="Research Related injury covered"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="ACNOTCICOV"/>
        <display value="Acute but not chronic injury covered"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="OTHINSTRES"/>
        <display value="Researchers at other institutions"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="THISINSTRES"/>
        <display value="Researchers outside the study team at this institution"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="EXTREGAUTH"/>
        <display value="External Regulatory Authorities"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="DEIDUSED"/>
        <display
                 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."/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="DEIDNOTUSED"/>
        <display
                 value="Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified."/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="sourceQuestionnaireResponse"/>
        <display
                 value="The content of the Questionnaire Response transferred to this Questionnaire during form launch"/>
        <definition
                    value="The content of the Questionnaire Response transferred to this Questionnaire during form launch"/>
      </concept>
      <concept>
        <code value="ResultsInDeath"/>
        <display value="Results in death"/>
        <definition value="Results in death"/>
      </concept>
      <concept>
        <code value="IsLifeThreatening"/>
        <display value="Is Life-threatening"/>
        <definition value="Is Life-threatening"/>
      </concept>
      <concept>
        <code value="ResultsInHospitalization"/>
        <display value="Requires or prolongs inpatient hospitalization"/>
        <definition value="Requires or prolongs inpatient hospitalization"/>
      </concept>
      <concept>
        <code value="IsBirthDefect"/>
        <display value="Is a congenital anomaly/birth defect"/>
        <definition value="Is a congenital anomaly/birth defect"/>
      </concept>
      <concept>
        <code value="ResultsInDisability"/>
        <display
                 value="Results in persistent or significant disability/incapacity"/>
        <definition
                    value="Results in persistent or significant disability/incapacity"/>
      </concept>
      <concept>
        <code value="RequiresPreventImpairment"/>
        <display value="Requires intervention to prevent permanent impairment"/>
        <definition
                    value="Requires intervention to prevent permanent impairment"/>
      </concept>
      <concept>
        <code value="Other"/>
        <display value="Other"/>
        <definition value="TBD"/>
      </concept>
      <concept>
        <code value="RCVRED"/>
        <display value="Recovered/Resolved"/>
        <definition value="Recovered/Resolved"/>
      </concept>
      <concept>
        <code value="RCVRING"/>
        <display value="Recovering/Resolving"/>
        <definition value="Recovering/Resolving"/>
      </concept>
      <concept>
        <code value="NRCVRED"/>
        <display value="Not recovered/Not resolved/Ongoing"/>
        <definition value="Not recovered/Not resolved/Ongoing"/>
      </concept>
      <concept>
        <code value="SEQL"/>
        <display value="Recovered/Resolved with sequelae"/>
        <definition value="Recovered/Resolved with sequelae"/>
      </concept>
      <concept>
        <code value="FATAL"/>
        <display value="Fatal"/>
        <definition value="Fatal"/>
      </concept>
      <concept>
        <code value="UNK"/>
        <display value="Unknown"/>
        <definition value="Unknown"/>
      </concept>
      <concept>
        <code value="NC"/>
        <display value="Product dose or frequency of use not changed"/>
        <definition value="Product dose or frequency of use not changed"/>
      </concept>
      <concept>
        <code value="NA"/>
        <display value="Not applicable"/>
        <definition value="Not applicable"/>
      </concept>
      <concept>
        <code value="PreviousAccrual"/>
        <display value="Previous Accrual"/>
        <definition value="Previous Accrual"/>
      </concept>
      <concept>
        <code value="AdditionalEnrollees"/>
        <display value="Additional enrollees this approval period"/>
        <definition value="Additional enrollees this approval period"/>
      </concept>
    </CodeSystem>