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 
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:QuestionnaireResponse;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "CONSENT-QR"];
fhir:Resource.meta [
fhir:Meta.versionId [ fhir:value "2" ];
fhir:Meta.lastUpdated [ fhir:value "2021-07-28T19:30:37.108+00:00"^^xsd:dateTime ];
fhir:Meta.source [ fhir:value "#Sq2VNRdBGuGpbfk1" ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href=\"http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 27, 2021 3:10:59 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2</p><p><b>text</b>: Site Principal Investigator</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.2</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.1</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.3</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.4</p><p><b>text</b>: Associated Institution</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.5</p><p><b>text</b>: Contact Information</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c3</p><p><b>text</b>: Relying Institution</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c3.1</p><p><b>text</b>: Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c3.2</p><p><b>text</b>: Address</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c4</p><p><b>text</b>: Sponsor or Funding Source</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c4.1</p><p><b>text</b>: Sponsor Name</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c6</p><p><b>text</b>: Is this consent an eConsent?</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 N}\">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c7</p><p><b>text</b>: Summary Text</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c7.1</p><p><b>text</b>: Summary Text Statement</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c8</p><p><b>text</b>: Introduction and Statement of Research</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c8.1</p><p><b>text</b>: About Consent Form</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9</p><p><b>text</b>: Purpose</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.1</p><p><b>text</b>: Reason for Research</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.2</p><p><b>text</b>: Interactions with others</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.3</p><p><b>text</b>: Invited Participants</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.4</p><p><b>text</b>: Total expected study enrollment</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.5</p><p><b>text</b>: Additional Enrollment Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.6</p><p><b>text</b>: What is involved in the study?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c10</p><p><b>text</b>: Assessments</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c10.1</p><p><b>text</b>: Assessment List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c10.1</p><p><b>text</b>: Assessment List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c10.2</p><p><b>text</b>: Assessment Supplemental Text</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11</p><p><b>text</b>: Visits and Procedures</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.2</p><p><b>text</b>: Visit List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.2</p><p><b>text</b>: Visit List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.3</p><p><b>text</b>: Procedure List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.3</p><p><b>text</b>: Procedure List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.4</p><p><b>text</b>: Procedure Supplemental Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.5</p><p><b>text</b>: Total Duration of Study Participation</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c12</p><p><b>text</b>: Risks</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c12.1</p><p><b>text</b>: Risk List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c12.2</p><p><b>text</b>: Risk Supplemental Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c12.3</p><p><b>text</b>: Fetal Risks</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c13</p><p><b>text</b>: Alternative Procedures</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c13.1</p><p><b>text</b>: Alternative Procedure Text</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14</p><p><b>text</b>: Benefits</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.1</p><p><b>text</b>: Name of Benefit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.2</p><p><b>text</b>: Description of Benefit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.3</p><p><b>text</b>: Benefit to you</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.4</p><p><b>text</b>: Benefit to society</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15</p><p><b>text</b>: Compensation</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.1</p><p><b>text</b>: Will there be compensation for participation?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.2</p><p><b>text</b>: Compensation Supplemental Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.3</p><p><b>text</b>: Compensation List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.3</p><p><b>text</b>: Compensation List</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c16</p><p><b>text</b>: Costs</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c16.1</p><p><b>text</b>: What are the costs of participation, if any?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c16.2</p><p><b>text</b>: Will there be reimbursement for other study visit costs incurred?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c16.3</p><p><b>text</b>: Who will pay for medical treatment if research related injury occurs?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17</p><p><b>text</b>: Participant Rights and whom to contact for answers</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.1</p><p><b>text</b>: What are the rights of a participant?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.2</p><p><b>text</b>: Site IRB Contact Information</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.3</p><p><b>text</b>: Study Coordinator Contact Information</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.4</p><p><b>text</b>: Site Principal Investigator Contact Information</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c18</p><p><b>text</b>: Participation</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c18.1</p><p><b>text</b>: Voluntary Permission Statement</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c18.2</p><p><b>text</b>: What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c19</p><p><b>text</b>: Early Withdrawal</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c19.1</p><p><b>text</b>: Are there consequences to participant for early withdrawal?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c19.2</p><p><b>text</b>: Are there Emotional Consequences of Withdrawal</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c19.3</p><p><b>text</b>: Are there Physical Consequences of Withdrawal</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20</p><p><b>text</b>: Confidentiality of Records</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.1</p><p><b>text</b>: Will HIPAA content be included within this document?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.3</p><p><b>text</b>: Will confidentiality be protected?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.4</p><p><b>text</b>: How will confidentiality be protected?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.5</p><p><b>text</b>: Are there data security or policies that need to be included in the consent, particularly around device use (optional)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.7</p><p><b>text</b>: Who can use or see participant information?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.8</p><p><b>text</b>: Will the data be released for future use?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.9</p><p><b>text</b>: Will the future use data be deidentified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.10</p><p><b>text</b>: Deidentification detail</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.11</p><p><b>text</b>: Required text disclosure surrounding future use.</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21</p><p><b>text</b>: Specimen Management</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.1</p><p><b>text</b>: Were specimens collected as part of this study?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.2</p><p><b>text</b>: Is whole genome sequencing being conducted?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.3</p><p><b>text</b>: Sharing or no Sharing of samples.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.4</p><p><b>text</b>: Conditions of sharing</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.5</p><p><b>text</b>: Will participant share in profit with commerical use?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.6</p><p><b>text</b>: Description of Collection and Storage</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.7</p><p><b>text</b>: Can consent for sample use be revoked?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c22</p><p><b>text</b>: Will there be Broad Consent for Storage, maintenance and secondary research use?</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 N}\">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c23</p><p><b>text</b>: Can the study team contact you for future research?</p><blockquote><p><b>answer</b></p><p><b>value</b>: <span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 Y}\">Yes</span></p><blockquote><p><b>item</b></p><p><b>linkId</b>: c23.1</p><p><b>text</b>: Conditions about contact for additional sample use, information not currently described or future research</p></blockquote></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c24</p><p><b>text</b>: Will participants share in commercial profit?</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 N}\">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c25</p><p><b>text</b>: Will the study team contact you with new information that may affect your willingness to remain in the study</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 N}\">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c26</p><p><b>text</b>: Will the study team disclose clinically relevant study results to you?</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 N}\">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c27</p><p><b>text</b>: Clinical Trials.gov statement</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td>A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.</td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c28</p><p><b>text</b>: Is this study covered under a Certificate of Confidentiality? (default Y in NIH)</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 N}\">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c30</p><p><b>text</b>: Statement of PHI Authorization Revocation</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td>Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.</td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c31</p><p><b>text</b>: Signature</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c31.1</p><p><b>text</b>: Indicator to include Participant Signature and Date/Time</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c31.2</p><p><b>text</b>: Indicator to include Assent Signature and Date/Time</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c31.3</p><p><b>text</b>: Indicator to include Legally Authorized Representative Signature and Date/Time</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c32</p><p><b>text</b>: Protocol or Study Number</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c32.1</p><p><b>text</b>: IRB Number</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><p><b>item</b></p><p><b>linkId</b>: ADMIN02</p><p><b>text</b>: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN03</p><p><b>text</b>: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any</p></blockquote></blockquote></div>"
];
fhir:QuestionnaireResponse.questionnaire [
fhir:value "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire";
fhir:link <http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire>
];
fhir:QuestionnaireResponse.status [ fhir:value "completed"];
fhir:QuestionnaireResponse.authored [ fhir:value "2021-07-27T15:10:59.524Z"^^xsd:dateTime];
fhir:QuestionnaireResponse.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Study" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "A clinical study of the efficacy of Drug A" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "IRB Protocol Number" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "A1234" ] ] ]
], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Jane" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Doe" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Degree(s)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MD" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Associated Institution" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Research University" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c2.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Contact Information" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "jdoe@xresearch.edu" ] ] ]
], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Institution" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Study Clinic A" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "111 Main St, Anytown, NC" ] ] ]
], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Sponsor or Funding Source" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c4.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Sponsor Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "National Government Funder" ] ] ]
], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is this consent an eConsent?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ]
], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Summary Text" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Summary Text Statement" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "This field contains a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental." ] ] ]
], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Introduction and Statement of Research" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c8.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "About Consent Form" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. You may take this consent form home to think about and discuss with family or friends." ] ] ]
], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Purpose" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Reason for Research" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "This study is to determine the efficacy of Drug A and whether it is more effective than the standard of care treatment." ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Interactions with others" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures." ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Invited Participants" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Candidates for this study include patients suffering the a common chronic disease." ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Total expected study enrollment" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "500"^^xsd:integer ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Additional Enrollment Text" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Additional Text can be inserted here." ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c9.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What is involved in the study?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "This study will involve an initial visit, a baseline clinical visit where several measurements will be taken, a follow up visit and an end of study visit." ] ] ]
], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Assessments" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Assessment List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of the Assessment" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Initial demographic data survey" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of Assessment" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants will be asked about" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Assessment List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of the Assessment" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Blood Draw" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of Assessment" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "3 tubes totaling 15 ml of blood will be drawn." ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c10.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Assessment Supplemental Text" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Additional Text about the assessments." ] ] ]
], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visits and Procedures" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Type" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Baseline Visit" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Description" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Collection of baseline measures" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Duration" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "2" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Duration Units" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Coding.code [ fhir:value "h" ];
fhir:Coding.display [ fhir:value "h" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Number of Visits" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "1"^^xsd:integer ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Type" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Follow up Visit" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Description" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Recurring monthly visits" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Duration" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "30" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Visit Duration Units" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Coding.code [ fhir:value "min" ];
fhir:Coding.display [ fhir:value "min" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.2.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Number of Visits" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "6"^^xsd:integer ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Procedure List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of Procedure" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Weight" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Common Term of Procedure" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Weight" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of a Procedure" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants will be weighed on a scale" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Experimental Procedure Indicator" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Indicator" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "STDCR" ];
fhir:Coding.display [ fhir:value "Standard of Care" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Frequency of Procedures" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDecimal [ fhir:value "7"^^xsd:decimal ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Procedure Duration (minutes)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDecimal [ fhir:value "1"^^xsd:decimal ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Procedure List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of Procedure" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Venipuncture" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Common Term of Procedure" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Blood Draw" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of a Procedure" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Phelebotomist will draw 20 ml of blood" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Experimental Procedure Indicator" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Indicator" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "STDCR" ];
fhir:Coding.display [ fhir:value "Standard of Care" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Frequency of Procedures" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDecimal [ fhir:value "1"^^xsd:decimal ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.3.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Procedure Duration (minutes)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDecimal [ fhir:value "15"^^xsd:decimal ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Procedure Supplemental Text" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Additional Text can be captured here" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c11.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Total Duration of Study Participation" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "7 months" ] ] ]
], [
fhir:index 10;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Risks" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Risk List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of the risk" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Bruising" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of Risk" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Blood draw may cause some mild bruising" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12.1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Risk Category" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "PHYS" ];
fhir:Coding.display [ fhir:value "Physical" ] ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Risk Supplemental Text" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Additional risk text can be included here" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c12.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Fetal Risks" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 11;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c13" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Alternative Procedures" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c13.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Alternative Procedure Text" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants are free to not participate at no additional risk." ] ] ]
], [
fhir:index 12;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c14" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Benefits" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c14.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of Benefit" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Societal Benefit of additional knowledge" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c14.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of Benefit" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Societal Benefit" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c14.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Benefit to you" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c14.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Benefit to society" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ]
], [
fhir:index 13;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Compensation" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will there be compensation for participation?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Compensation Supplemental Text" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Description of compensation can be included" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Compensation List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What types of visits or milestones will I be compensated for?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Baseline" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "How many visits or milestones of this type will there be compensation for?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "1"^^xsd:integer ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "How much will be paid per that type of visit?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "100" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Compensation List" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What types of visits or milestones will I be compensated for?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Followup" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "How many visits or milestones of this type will there be compensation for?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "6"^^xsd:integer ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c15.3.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "How much will be paid per that type of visit?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "25" ] ] ] ]
], [
fhir:index 14;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c16" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Costs" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c16.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What are the costs of participation, if any?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants will be responsible for costs beyond the provided payment." ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c16.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will there be reimbursement for other study visit costs incurred?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c16.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Who will pay for medical treatment if research related injury occurs?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "TRTNOTCOV" ];
fhir:Coding.display [ fhir:value "Treatment not covered" ] ] ] ]
], [
fhir:index 15;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c17" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participant Rights and whom to contact for answers" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c17.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What are the rights of a participant?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participant rights text" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c17.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site IRB Contact Information" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Study Coordinator name, role" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c17.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Coordinator Contact Information" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Study Coordinator phone or email" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c17.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator Contact Information" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Site PI email or other contact information" ] ] ]
], [
fhir:index 16;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c18" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participation" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c18.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Voluntary Permission Statement" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled." ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c18.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent." ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants can be removed from the study if their condition changes such that the study procedures are not advised for their existing conditions." ] ] ]
], [
fhir:index 17;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c19" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Early Withdrawal" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c19.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are there consequences to participant for early withdrawal?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c19.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are there Emotional Consequences of Withdrawal" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c19.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are there Physical Consequences of Withdrawal" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 18;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Confidentiality of Records" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will HIPAA content be included within this document?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will confidentiality be protected?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "How will confidentiality be protected?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Yes, data will be deidentified in all cases." ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are there data security or policies that need to be included in the consent, particularly around device use (optional)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Who can use or see participant information?" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Role or group who will have access to data" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "OTHINSTRES" ];
fhir:Coding.display [ fhir:value "Researchers at other institutions" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of Information Disclosed" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Deidentified demographic data" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will the data be released for future use?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will the future use data be deidentified?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Deidentification detail" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Only demographic data will be shared" ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c20.11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Required text disclosure surrounding future use." ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "DEIDUSED" ];
fhir:Coding.display [ fhir:value "Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent." ] ] ] ]
], [
fhir:index 19;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Specimen Management" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Were specimens collected as part of this study?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is whole genome sequencing being conducted?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Sharing or no Sharing of samples." ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Conditions of sharing" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Deidentified samples will be shared with other investigators at this institution." ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will participant share in profit with commerical use?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description of Collection and Storage" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Samples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion." ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c21.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Can consent for sample use be revoked?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 20;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c22" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will there be Broad Consent for Storage, maintenance and secondary research use?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ]
], [
fhir:index 21;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c23" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Can the study team contact you for future research?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ];
fhir:QuestionnaireResponse.item.answer.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c23.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Conditions about contact for additional sample use, information not currently described or future research" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants can be called for up to 1 year after conclusion of the study." ] ] ] ]
], [
fhir:index 22;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c24" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will participants share in commercial profit?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ]
], [
fhir:index 23;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c25" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will the study team contact you with new information that may affect your willingness to remain in the study" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ]
], [
fhir:index 24;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c26" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Will the study team disclose clinically relevant study results to you?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ]
], [
fhir:index 25;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c27" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Clinical Trials.gov statement" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time." ] ]
], [
fhir:index 26;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c28" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is this study covered under a Certificate of Confidentiality? (default Y in NIH)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ]
], [
fhir:index 27;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c30" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Statement of PHI Authorization Revocation" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared." ] ]
], [
fhir:index 28;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c31" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Signature" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c31.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Indicator to include Participant Signature and Date/Time" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c31.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Indicator to include Assent Signature and Date/Time" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c31.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Indicator to include Legally Authorized Representative Signature and Date/Time" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 29;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c32" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Protocol or Study Number" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "c32.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "IRB Number" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "IRB41512" ] ] ]
], [
fhir:index 30;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN00" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Administrative Use Only" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN01" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Link ID prefix" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "c" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN02" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "temporarily unavailable" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN03" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "temporarily unavailable" ] ] ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
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
Links: Table of Contents |
QA Report
| Version History |
Search |
|
Propose a change