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 
{
"resourceType" : "QuestionnaireResponse",
"id" : "NME-QR",
"meta" : {
"versionId" : "3",
"lastUpdated" : "2021-07-27T02:23:03.257+00:00",
"source" : "#Eo51qLbujzofNeCw"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href=\"https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire\">https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 2:37:12 AM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1.1</p><p><b>text</b>: Study Title:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1.3</p><p><b>text</b>: IRB Protocol Number:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1.4</p><p><b>text</b>: Status:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2a</p><p><b>text</b>: Site/Organization</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2a.1</p><p><b>text</b>: Organization/site where the Adverse Non-Medical Event occurred</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2a.2</p><p><b>text</b>: Organization/site which is recording the Adverse Non-Medical Event</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b</p><p><b>text</b>: Site Principal Investigator for the site where Adverse Non-Medical Event occurred</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.4</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.5</p><p><b>text</b>: Suffix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.6</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.2</p><p><b>text</b>: Phone:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.3</p><p><b>text</b>: Email:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3</p><p><b>text</b>: Report</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.1</p><p><b>text</b>: Report Date:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.2</p><p><b>text</b>: Report Status</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.4</p><p><b>text</b>: New information resulted in unexpected change in risks of the research.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.5</p><p><b>text</b>: New or increased risk</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.6</p><p><b>text</b>: Unanticipated Problem Involving Risk to Participants or Others</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.7</p><p><b>text</b>: Unanticipated Problem</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.8</p><p><b>text</b>: Protocol Deviation (accidental or unintentional)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.9</p><p><b>text</b>: Protocol Deviation (Non-Compliance)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.10</p><p><b>text</b>: A breach of Confidentiality</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.11</p><p><b>text</b>: Breach of Confidentiality</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.12</p><p><b>text</b>: Incarceration of a participant in a protocol not approved to enroll prisoners</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.13</p><p><b>text</b>: Incarceration</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.14</p><p><b>text</b>: Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.15</p><p><b>text</b>: Participant Complaint</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.16</p><p><b>text</b>: Other Type of Adverse Non-Medical Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.17</p><p><b>text</b>: Other Type</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4</p><p><b>text</b>: Reporting</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.1</p><p><b>text</b>: Was the Sponsor notified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.2</p><p><b>text</b>: Notification date:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.3</p><p><b>text</b>: Was the IRB notified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.4</p><p><b>text</b>: Notification date:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.5</p><p><b>text</b>: Were any Other Parties notified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.6</p><p><b>text</b>: Please list other notified parties</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5</p><p><b>text</b>: Corrective and Preventative Action Plan</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.1</p><p><b>text</b>: Was a Root Cause analysis performed?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.2a</p><p><b>text</b>: If yes, provide determination:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.3</p><p><b>text</b>: Was Corrective Action implemented?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.4</p><p><b>text</b>: If Corrective Action was implemented or is pending, provide a summary:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.5</p><p><b>text</b>: Was Preventitive Action implemented?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.6</p><p><b>text</b>: If Preventitive Action was implemented or is pending, provide a summary:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6</p><p><b>text</b>: Study Protocol and Informed Consent</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.1a</p><p><b>text</b>: Are changes required to the Study Protocol as a result of this report?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.3a</p><p><b>text</b>: Are changes required to the Informed Consent as a result of this report?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.5</p><p><b>text</b>: Are notifications or re-consenting of participants required as a result of this change?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.6</p><p><b>text</b>: If yes, detail how the notification and/or re-consent will occur:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only</p><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN01</p><p><b>text</b>: Link ID prefix</p></blockquote></blockquote></div>"
},
"questionnaire" : "https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire",
"status" : "completed",
"authored" : "2021-07-23T02:37:12.835Z",
"item" : [
{
"linkId" : "nme1",
"text" : "Research Study",
"item" : [
{
"linkId" : "nme1.1",
"text" : "Study Title:",
"answer" : [
{
"valueString" : "The Effect of Drug A."
}
]
},
{
"linkId" : "nme1.3",
"text" : "IRB Protocol Number:",
"answer" : [
{
"valueString" : "44567hyujd"
}
]
},
{
"linkId" : "nme1.4",
"text" : "Status:",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "nochange",
"display" : "No change in research activities"
}
}
]
}
]
},
{
"linkId" : "nme2a",
"text" : "Site/Organization",
"item" : [
{
"linkId" : "nme2a.1",
"text" : "Organization/site where the Adverse Non-Medical Event occurred",
"item" : [
{
"linkId" : "nme2a.1.1",
"text" : "Name of organization/site where the Adverse Non-Medical Event occurred",
"answer" : [
{
"valueString" : "Duke"
}
]
},
{
"linkId" : "nme2a.1.2",
"text" : "City",
"answer" : [
{
"valueString" : "Durham"
}
]
},
{
"linkId" : "nme2a.1.3",
"text" : "State",
"answer" : [
{
"valueString" : "NC"
}
]
},
{
"linkId" : "nme2a.1.4",
"text" : "Country",
"answer" : [
{
"valueString" : "USA"
}
]
}
]
},
{
"linkId" : "nme2a.2",
"text" : "Organization/site which is recording the Adverse Non-Medical Event",
"item" : [
{
"linkId" : "nme2a.2.1",
"text" : "Name of organization/site which is recording the Adverse Non-Medical Event",
"answer" : [
{
"valueString" : "Duke Regional Hospital"
}
]
},
{
"linkId" : "nme2a.2.2",
"text" : "City",
"answer" : [
{
"valueString" : "Durham"
}
]
},
{
"linkId" : "nme2a.2.3",
"text" : "State",
"answer" : [
{
"valueString" : "NC"
}
]
},
{
"linkId" : "nme2a.2.4",
"text" : "Country",
"answer" : [
{
"valueString" : "USA"
}
]
}
]
}
]
},
{
"linkId" : "nme2b",
"text" : "Site Principal Investigator for the site where Adverse Non-Medical Event occurred",
"item" : [
{
"linkId" : "nme2b.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "John"
}
]
},
{
"linkId" : "nme2b.4",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Blake"
}
]
},
{
"linkId" : "nme2b.5",
"text" : "Suffix",
"answer" : [
{
"valueString" : "II"
}
]
},
{
"linkId" : "nme2b.6",
"text" : "Degree(s)",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "nme2b.2",
"text" : "Phone:",
"answer" : [
{
"valueString" : "9198726765"
}
]
},
{
"linkId" : "nme2b.3",
"text" : "Email:",
"answer" : [
{
"valueString" : "blake@duke.edu"
}
]
}
]
},
{
"linkId" : "nme3",
"text" : "Report",
"item" : [
{
"linkId" : "nme3.1",
"text" : "Report Date:",
"answer" : [
{
"valueDate" : "2021-07-22"
}
]
},
{
"linkId" : "nme3.2",
"text" : "Report Status",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "init",
"display" : "Initial"
}
}
]
},
{
"linkId" : "nme3.4",
"text" : "New information resulted in unexpected change in risks of the research.",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.5",
"text" : "New or increased risk",
"item" : [
{
"linkId" : "nme3.5.1",
"text" : "Date:",
"answer" : [
{
"valueDate" : "2021-07-22"
}
]
},
{
"linkId" : "nme3.5.2",
"text" : "Date discovered:",
"answer" : [
{
"valueDate" : "2021-07-21"
}
]
},
{
"linkId" : "nme3.5.3",
"text" : "Description:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme3.6",
"text" : "Unanticipated Problem Involving Risk to Participants or Others",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.7",
"text" : "Unanticipated Problem",
"item" : [
{
"linkId" : "nme3.7.1",
"text" : "Event date:",
"answer" : [
{
"valueDate" : "2021-07-15"
}
]
},
{
"linkId" : "nme3.7.2",
"text" : "Date event became aware to study team:",
"answer" : [
{
"valueDate" : "2021-07-20"
}
]
},
{
"linkId" : "nme3.7.3",
"text" : "Event Summary:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme3.7.4",
"text" : "Was this event Unexpected?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme3.7.5",
"text" : "If yes, please explain:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme3.7.6",
"text" : "Was this event Related or Possibly Related to participation in the research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme3.7.7",
"text" : "If yes, please explain:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme3.7.8",
"text" : "Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme3.7.9",
"text" : "If yes, please explain:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme3.8",
"text" : "Protocol Deviation (accidental or unintentional)",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9",
"text" : "Protocol Deviation (Non-Compliance)",
"item" : [
{
"linkId" : "nme3.9.4",
"text" : "Does the deviation involve any of the following? (Check all that apply)",
"item" : [
{
"linkId" : "nme3.9.4.1",
"text" : "Failure to obtain informed consent when IRB deemed required",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9.4.2",
"text" : "Modifying the protocol without IRB approval, except to avoid hazard to participants",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9.4.3",
"text" : "Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9.4.4",
"text" : "Please explain any Checked items:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme3.9.5",
"text" : "Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)",
"item" : [
{
"linkId" : "nme3.9.5.1",
"text" : "The rights, welfare, or safety of the participants",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9.5.2",
"text" : "The integrity of the research area",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9.5.3",
"text" : "The participants' willingness to continue participation",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.9.5.4",
"text" : "Please explain any Checked items:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
}
]
},
{
"linkId" : "nme3.10",
"text" : "A breach of Confidentiality",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.11",
"text" : "Breach of Confidentiality",
"item" : [
{
"linkId" : "nme3.11.1",
"text" : "Date breach occurred",
"answer" : [
{
"valueDate" : "2021-07-21"
}
]
},
{
"linkId" : "nme3.11.2",
"text" : "Date discovered:",
"answer" : [
{
"valueDate" : "2021-07-21"
}
]
},
{
"linkId" : "nme3.11.3",
"text" : "Description:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme3.12",
"text" : "Incarceration of a participant in a protocol not approved to enroll prisoners",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.13",
"text" : "Incarceration",
"item" : [
{
"linkId" : "nme3.13.1",
"text" : "Date:",
"answer" : [
{
"valueDate" : "2021-07-14"
}
]
},
{
"linkId" : "nme3.13.2",
"text" : "Date incarceration was discovered:",
"answer" : [
{
"valueDate" : "2021-07-14"
}
]
},
{
"linkId" : "nme3.13.3",
"text" : "Description:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme3.14",
"text" : "Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team.",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.15",
"text" : "Participant Complaint",
"item" : [
{
"linkId" : "nme3.15.1",
"text" : "Complaint Date:",
"answer" : [
{
"valueDate" : "2021-07-15"
}
]
},
{
"linkId" : "nme3.15.2",
"text" : "Date received:",
"answer" : [
{
"valueDate" : "2021-07-22"
}
]
},
{
"linkId" : "nme3.15.3",
"text" : "Description:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme3.16",
"text" : "Other Type of Adverse Non-Medical Event",
"answer" : [
{
"valueBoolean" : true
}
]
},
{
"linkId" : "nme3.17",
"text" : "Other Type",
"item" : [
{
"linkId" : "nme3.17.1",
"text" : "Event date:",
"answer" : [
{
"valueDate" : "2021-07-07"
}
]
},
{
"linkId" : "nme3.17.2",
"text" : "Date study team became aware of event:",
"answer" : [
{
"valueDate" : "2021-07-14"
}
]
},
{
"linkId" : "nme3.17.3",
"text" : "Event Summary:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme3.17.4",
"text" : "Was this Adverse Non-Medical Event Unexpected?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme3.17.5",
"text" : "If yes, please explain:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme3.17.6",
"text" : "Was this event Related or Possibly Related to participation in the research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme3.17.7",
"text" : "If yes, please explain:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
}
]
},
{
"linkId" : "nme4",
"text" : "Reporting",
"item" : [
{
"linkId" : "nme4.1",
"text" : "Was the Sponsor notified?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme4.2",
"text" : "Notification date:",
"answer" : [
{
"valueDate" : "2021-07-22"
}
]
},
{
"linkId" : "nme4.3",
"text" : "Was the IRB notified?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme4.4",
"text" : "Notification date:",
"answer" : [
{
"valueDate" : "2021-07-22"
}
]
},
{
"linkId" : "nme4.5",
"text" : "Were any Other Parties notified?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme4.6",
"text" : "Please list other notified parties",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "nme5",
"text" : "Corrective and Preventative Action Plan",
"item" : [
{
"linkId" : "nme5.1",
"text" : "Was a Root Cause analysis performed?",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "completed",
"display" : "Done, performed or completed"
}
}
]
},
{
"linkId" : "nme5.2a",
"text" : "If yes, provide determination:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme5.3",
"text" : "Was Corrective Action implemented?",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "pending",
"display" : "Pending - Currently under development"
}
}
]
},
{
"linkId" : "nme5.4",
"text" : "If Corrective Action was implemented or is pending, provide a summary:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
},
{
"linkId" : "nme5.5",
"text" : "Was Preventitive Action implemented?",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "completed",
"display" : "Done, performed or completed"
}
}
]
},
{
"linkId" : "nme5.6",
"text" : "If Preventitive Action was implemented or is pending, provide a summary:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "nme6",
"text" : "Study Protocol and Informed Consent",
"item" : [
{
"linkId" : "nme6.1a",
"text" : "Are changes required to the Study Protocol as a result of this report?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme6.3a",
"text" : "Are changes required to the Informed Consent as a result of this report?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme6.5",
"text" : "Are notifications or re-consenting of participants required as a result of this change?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "nme6.6",
"text" : "If yes, detail how the notification and/or re-consent will occur:",
"answer" : [
{
"valueString" : "[Text Description]"
}
]
}
]
},
{
"linkId" : "ADMIN00",
"text" : "Administrative Use Only",
"item" : [
{
"linkId" : "ADMIN01",
"text" : "Link ID prefix",
"answer" : [
{
"valueString" : "nme"
}
]
}
]
}
]
}
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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