Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use
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
| Draft as of 2021-07-23 |
{
"resourceType" : "CodeSystem",
"id" : "temporarycodes",
"meta" : {
"versionId" : "25",
"lastUpdated" : "2022-03-01T05:48:06.916+00:00",
"source" : "#xB060rjIVhkfCGdb",
"profile" : [
"http://hl7.org/fhir/StructureDefinition/shareablecodesystem"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"url" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"identifier" : [
{
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"value" : "temporary-codes"
}
],
"version" : "1.0.0",
"name" : "TemporaryCodes",
"title" : "Temporary Codes",
"status" : "draft",
"experimental" : true,
"date" : "2021-07-23",
"publisher" : "HL7 International - BR&R Work Group",
"contact" : [
{
"name" : "HL7 International - Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"description" : "This is a temporary codesystem capturing the custom codelists used across the sIRB forms.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
],
"text" : "United States of America"
}
],
"caseSensitive" : true,
"content" : "complete",
"concept" : [
{
"code" : "INITIAL",
"display" : "Initial",
"definition" : "TBD"
},
{
"code" : "UPDATE",
"display" : "Update",
"definition" : "TBD"
},
{
"code" : "INT",
"display" : "Interventional",
"definition" : "TBD"
},
{
"code" : "OBS",
"display" : "Observational",
"definition" : "TBD"
},
{
"code" : "APPROVED",
"display" : "Approved for reliance",
"definition" : "TBD"
},
{
"code" : "POSSIBLE",
"display" : "Potential/possible",
"definition" : "TBD"
},
{
"code" : "CANCELLED",
"display" : "Cancelled or not participating",
"definition" : "TBD"
},
{
"code" : "ONHOLD",
"display" : "Temporarily on hold",
"definition" : "TBD"
},
{
"code" : "DENIED",
"display" : "Denied reliance",
"definition" : "TBD"
},
{
"code" : "SFS",
"display" : "Sponsor or Funding Source",
"definition" : "TBD"
},
{
"code" : "CRO",
"display" : "Contract Research Organization (CRO)",
"definition" : "TBD"
},
{
"code" : "AR",
"display" : "Accepts Review",
"definition" : "TBD"
},
{
"code" : "DR",
"display" : "Denies Review",
"definition" : "TBD"
},
{
"code" : "PHONECALL",
"display" : "Telephone calls",
"definition" : "TBD"
},
{
"code" : "VM",
"display" : "Voice mail and telephone voice messages",
"definition" : "TBD"
},
{
"code" : "VC",
"display" : "Video Conferencing",
"definition" : "TBD"
},
{
"code" : "EMAIL",
"display" : "Email",
"definition" : "TBD"
},
{
"code" : "TXT",
"display" : "Text messages/texting",
"definition" : "TBD"
},
{
"code" : "EHPRTL",
"display" : "eHealth Portal messaging",
"definition" : "TBD"
},
{
"code" : "SA",
"display" : "Study Agent",
"definition" : "TBD"
},
{
"code" : "PLACEBO",
"display" : "Placebo",
"definition" : "TBD"
},
{
"code" : "BSA",
"display" : "Blinded Study Agent",
"definition" : "TBD"
},
{
"code" : "PRMYDIS",
"display" : "Primary disease",
"definition" : "TBD"
},
{
"code" : "STDYPRO",
"display" : "Study Procedure",
"definition" : "TBD"
},
{
"code" : "PRE",
"display" : "Pre-existing condition",
"definition" : "TBD"
},
{
"code" : "UNDERLYINGDIS",
"display" : "Underlying disease",
"definition" : "TBD"
},
{
"code" : "CONCMITMED",
"display" : "Concomitant medication",
"definition" : "TBD"
},
{
"code" : "OTHERCAUSE",
"display" : "Other known or suspected cause",
"definition" : "TBD"
},
{
"code" : "nochange",
"display" : "No change in research activities",
"definition" : "TBD"
},
{
"code" : "stopped",
"display" : "All research activities temporarily and voluntarily stopped for all participants",
"definition" : "TBD"
},
{
"code" : "partial",
"display" : "Partial voluntary hold on some research activities for all participants (explain below)",
"definition" : "TBD"
},
{
"code" : "hold",
"display" : "Voluntary hold on new participant enrollment only",
"definition" : "TBD"
},
{
"code" : "init",
"display" : "Initial",
"definition" : "TBD"
},
{
"code" : "followup",
"display" : "Follow-up",
"definition" : "TBD"
},
{
"code" : "completed",
"display" : "Done, performed or completed",
"definition" : "The action was done, performed or completed"
},
{
"code" : "pending",
"display" : "Pending - Currently under development",
"definition" : "The action is in progress or status is pending"
},
{
"code" : "notundertaken",
"display" : "Not done or undertaken",
"definition" : "The action was not started and is not in progress"
},
{
"code" : "mla",
"display" : "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" : "TBD"
},
{
"code" : "mtd",
"display" : "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" : "TBD"
},
{
"code" : "otherreason",
"display" : "Other reason",
"definition" : "TBD"
},
{
"code" : "open",
"display" : "Open for enrollment",
"definition" : "TBD"
},
{
"code" : "closed",
"display" : "Closed to enrollment",
"definition" : "TBD"
},
{
"code" : "not-open",
"display" : "Not yet open",
"definition" : "TBD"
},
{
"code" : "open-no-participants",
"display" : "Open with no participants",
"definition" : "TBD"
},
{
"code" : "complete",
"display" : "All interventions complete",
"definition" : "TBD"
},
{
"code" : "continue-meds",
"display" : "Continuing interventions",
"definition" : "TBD"
},
{
"code" : "continue-min-risk",
"display" : "Continuing interventions - minimal risk",
"definition" : "TBD"
},
{
"code" : "federal",
"display" : "Federal",
"definition" : "TBD"
},
{
"code" : "state",
"display" : "State",
"definition" : "TBD"
},
{
"code" : "industry",
"display" : "Industry",
"definition" : "TBD"
},
{
"code" : "foundation",
"display" : "Foundation",
"definition" : "TBD"
},
{
"code" : "institutional",
"display" : "Institutional",
"definition" : "TBD"
},
{
"code" : "departmental",
"display" : "Departmental",
"definition" : "TBD"
},
{
"code" : "otherfund",
"display" : "Other Funding Source",
"definition" : "TBD"
},
{
"code" : "DBV",
"display" : "Drug/Biologic/Vaccine",
"definition" : "TBD"
},
{
"code" : "DEV",
"display" : "Device",
"definition" : "TBD"
},
{
"code" : "SBE",
"display" : "Social/Behavioral/educational (SBE)",
"definition" : "TBD"
},
{
"code" : "PRO",
"display" : "Procedural",
"definition" : "TBD"
},
{
"code" : "IND",
"display" : "IND",
"definition" : "TBD"
},
{
"code" : "IDE",
"display" : "IDE",
"definition" : "TBD"
},
{
"code" : "COPI",
"display" : "Co-Principal Investigator",
"definition" : "TBD"
},
{
"code" : "COI",
"display" : "Co-Investigator",
"definition" : "TBD"
},
{
"code" : "PD",
"display" : "Program Director",
"definition" : "TBD"
},
{
"code" : "RES",
"display" : "Research",
"definition" : "TBD"
},
{
"code" : "STDCR",
"display" : "Standard of Care",
"definition" : "TBD"
},
{
"code" : "PHYS",
"display" : "Physical",
"definition" : "TBD"
},
{
"code" : "NONPHYS",
"display" : "Non-Physical",
"definition" : "TBD"
},
{
"code" : "TRTNOTCOV",
"display" : "Treatment not covered",
"definition" : "TBD"
},
{
"code" : "RRICOV",
"display" : "Research Related injury covered",
"definition" : "TBD"
},
{
"code" : "ACNOTCICOV",
"display" : "Acute but not chronic injury covered",
"definition" : "TBD"
},
{
"code" : "OTHINSTRES",
"display" : "Researchers at other institutions",
"definition" : "TBD"
},
{
"code" : "THISINSTRES",
"display" : "Researchers outside the study team at this institution",
"definition" : "TBD"
},
{
"code" : "EXTREGAUTH",
"display" : "External Regulatory Authorities",
"definition" : "TBD"
},
{
"code" : "DEIDUSED",
"display" : "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" : "TBD"
},
{
"code" : "DEIDNOTUSED",
"display" : "Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.",
"definition" : "TBD"
},
{
"code" : "sourceQuestionnaireResponse",
"display" : "The content of the Questionnaire Response transferred to this Questionnaire during form launch",
"definition" : "The content of the Questionnaire Response transferred to this Questionnaire during form launch"
},
{
"code" : "ResultsInDeath",
"display" : "Results in death",
"definition" : "Results in death"
},
{
"code" : "IsLifeThreatening",
"display" : "Is Life-threatening",
"definition" : "Is Life-threatening"
},
{
"code" : "ResultsInHospitalization",
"display" : "Requires or prolongs inpatient hospitalization",
"definition" : "Requires or prolongs inpatient hospitalization"
},
{
"code" : "IsBirthDefect",
"display" : "Is a congenital anomaly/birth defect",
"definition" : "Is a congenital anomaly/birth defect"
},
{
"code" : "ResultsInDisability",
"display" : "Results in persistent or significant disability/incapacity",
"definition" : "Results in persistent or significant disability/incapacity"
},
{
"code" : "RequiresPreventImpairment",
"display" : "Requires intervention to prevent permanent impairment",
"definition" : "Requires intervention to prevent permanent impairment"
},
{
"code" : "Other",
"display" : "Other",
"definition" : "TBD"
},
{
"code" : "RCVRED",
"display" : "Recovered/Resolved",
"definition" : "Recovered/Resolved"
},
{
"code" : "RCVRING",
"display" : "Recovering/Resolving",
"definition" : "Recovering/Resolving"
},
{
"code" : "NRCVRED",
"display" : "Not recovered/Not resolved/Ongoing",
"definition" : "Not recovered/Not resolved/Ongoing"
},
{
"code" : "SEQL",
"display" : "Recovered/Resolved with sequelae",
"definition" : "Recovered/Resolved with sequelae"
},
{
"code" : "FATAL",
"display" : "Fatal",
"definition" : "Fatal"
},
{
"code" : "UNK",
"display" : "Unknown",
"definition" : "Unknown"
},
{
"code" : "NC",
"display" : "Product dose or frequency of use not changed",
"definition" : "Product dose or frequency of use not changed"
},
{
"code" : "NA",
"display" : "Not applicable",
"definition" : "Not applicable"
},
{
"code" : "PreviousAccrual",
"display" : "Previous Accrual",
"definition" : "Previous Accrual"
},
{
"code" : "AdditionalEnrollees",
"display" : "Additional enrollees this approval period",
"definition" : "Additional enrollees this approval period"
}
]
}
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#1.0.0 based on FHIR 4.0.1. Generated 2023-04-24
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