Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
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 
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<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>
</text>
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<identifier>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<value value="temporary-codes"/>
</identifier>
<version value="0.1.0"/>
<name value="TemporaryCodes"/>
<title value="Temporary Codes"/>
<status value="draft"/>
<experimental value="true"/>
<date value="2021-07-23"/>
<publisher value="HL7 International - BR&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="sIRB"/>
<display value="sIRB (Reviewing Site)"/>
<definition value="Site is the sIRB"/>
</concept>
<concept>
<code value="Relying"/>
<display value="Relying Site"/>
<definition value="Site is the Relying Site"/>
</concept>
<concept>
<code value="VM"/>
<display value="Telephone and 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-intvnt"/>
<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="Other"/>
<display value="Other"/>
<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="continue-meds"/>
<display value="Continuing interventions"/>
<definition value="TBD"/>
</concept>
</CodeSystem>
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#0.1.0 based on FHIR 4.0.1. Generated 2021-08-10
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