Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
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"div" : "<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-protocol-questionnaire\">https://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 2:13:33 AM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.1</p><p><b>text</b>: Study Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.2</p><p><b>text</b>: Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.3</p><p><b>text</b>: Does this protocol require an FDA exemption?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.4</p><p><b>text</b>: Type of exemption</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.5</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.6</p><p><b>text</b>: Study Title (Short)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.61</p><p><b>text</b>: Principal Investigator</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.7</p><p><b>text</b>: Additional Investigator</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.8</p><p><b>text</b>: Additional Investigator</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.9</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.10</p><p><b>text</b>: Sponsor Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.11</p><p><b>text</b>: ClinicalTrials.Gov Identifier</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.14</p><p><b>text</b>: IND Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.16</p><p><b>text</b>: Study Product Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.17</p><p><b>text</b>: Study Product Provider</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.18</p><p><b>text</b>: Funding Organization</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.19</p><p><b>text</b>: Sponsor</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.20</p><p><b>text</b>: Medical Monitor</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.21</p><p><b>text</b>: Confidentialty Statement</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.22</p><p><b>text</b>: Investigator's Signature</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.23</p><p><b>text</b>: Protocol Version Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p1.24</p><p><b>text</b>: Protocol Version Date</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p2.4</p><p><b>text</b>: Statement of Compliance</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td>The trial will be carried out in accordance with International Council on Harmonisation Good Clinical Practice (ICH GCP) and the following: tUnited States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human participants Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must be obtained before any participant is consented. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.</td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p3</p><p><b>text</b>: Protocol Summary</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p3.1</p><p><b>text</b>: Synopsis</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p3.2</p><p><b>text</b>: Schema</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p3.3</p><p><b>text</b>: Schedule of Activities</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p4</p><p><b>text</b>: INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONAL</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p4.1</p><p><b>text</b>: Background</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p4.2</p><p><b>text</b>: Study Rationale</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p4.3</p><p><b>text</b>: Risk/Benefit Assessment</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p5</p><p><b>text</b>: STUDY PURPOSE, OBJECTIVES OR SPECIFIC AIMS</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p5.1</p><p><b>text</b>: Hypothesis</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p5.2</p><p><b>text</b>: Primary Objectives</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p5.3</p><p><b>text</b>: Secondary Objectives</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p5.4</p><p><b>text</b>: Tertiary/Exploratory Objectives</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p6</p><p><b>text</b>: STUDY ENDPOINTS</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p6.1</p><p><b>text</b>: Primary Endpoints</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p6.2</p><p><b>text</b>: Secondary Endpoints</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p6.3</p><p><b>text</b>: Tertiary Endpoints</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p6.4</p><p><b>text</b>: Primary Safety endpoints</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p6.5</p><p><b>text</b>: Secondary Safety endpoints</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p6.6</p><p><b>text</b>: Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7</p><p><b>text</b>: STUDY DESIGN</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.1</p><p><b>text</b>: Overall Design</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.2</p><p><b>text</b>: Scientific Rationale for Study Design</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.3</p><p><b>text</b>: Justification for Dose</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.4</p><p><b>text</b>: Justification for Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.5</p><p><b>text</b>: End of Study Definition</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.6</p><p><b>text</b>: Screening Activities</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.7</p><p><b>text</b>: Study Intervention Activities</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.8</p><p><b>text</b>: Follow Up Activities</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.9</p><p><b>text</b>: Allocation to Interventional Group</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.10</p><p><b>text</b>: Study/Data Collection Instruments</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p7.11</p><p><b>text</b>: Research Setting</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p8</p><p><b>text</b>: STUDY POPULATION</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p8.1</p><p><b>text</b>: Participant Selection</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p9</p><p><b>text</b>: STUDY ENROLLMENT AND WITHDRAWAL</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p9.1</p><p><b>text</b>: Eligibility Criteria</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p9.2</p><p><b>text</b>: STRATEGIES FOR RECRUITMENT AND RETENTION</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p9.3</p><p><b>text</b>: DURATION OF STUDY PARTICIPATION. (If there are sub-studies, include duration of participation in each sub-study.)</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p10</p><p><b>text</b>: STUDY INTERVENTION</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p10.1</p><p><b>text</b>: Study Agent</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p10.3</p><p><b>text</b>: Study Procedural Intervention(s) Description</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p10.4</p><p><b>text</b>: Participant Compliance and Monitoring</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p10.5</p><p><b>text</b>: Study Intervention/Experimental Manipulation Adherence</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p11</p><p><b>text</b>: STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p11.1</p><p><b>text</b>: Discontinuation of Study Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p11.2</p><p><b>text</b>: Participant withdrawal and Termination</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p11.3</p><p><b>text</b>: Lost to Follow-Up</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12</p><p><b>text</b>: STUDY PROCEDURES</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.1</p><p><b>text</b>: Study Procedures/Evaluations</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.2</p><p><b>text</b>: Laboratory Procedures/Evaluations</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.3</p><p><b>text</b>: Data Collection and Follow Up for Withdrawn participants</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.4</p><p><b>text</b>: Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.5</p><p><b>text</b>: Precautionary Medications, Treatments, and Procedures</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.6</p><p><b>text</b>: Prohibited Medications, Treatments, and Procedures</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.7</p><p><b>text</b>: Prophylactic Medications, Treatments, and Procedures</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.8</p><p><b>text</b>: Rescue Medications, Treatments, and Procedures</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.9</p><p><b>text</b>: Participant Access to Study Agent at Study Closure</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p12.10</p><p><b>text</b>: Concomitant Medications, Treatments , and Procedures</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13</p><p><b>text</b>: SCHEDULE OF STUDY PROCEDURES</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.1</p><p><b>text</b>: Screening</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.2</p><p><b>text</b>: Enrollment/Visit 1/Baseline Visit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.3</p><p><b>text</b>: Intermediate Visits</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.4</p><p><b>text</b>: Final Study Visit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.5</p><p><b>text</b>: Withdrawal/Early Termination Visit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.6</p><p><b>text</b>: Unscheduled Visit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p13.7</p><p><b>text</b>: Follow Up Phase of the Study</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p14</p><p><b>text</b>: ASSESSMENT OF SAFETY</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p14.1</p><p><b>text</b>: Specification of Safety Parameters</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p14.2</p><p><b>text</b>: Classification of an Adverse Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p14.3</p><p><b>text</b>: Time Period and Frequencey for Event Assessment and Follow-Up</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p14.4</p><p><b>text</b>: Reporting Procedures</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p14.5</p><p><b>text</b>: Follow Up Report</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p14.6</p><p><b>text</b>: Study Halting/Stopping Rules</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15</p><p><b>text</b>: STATISTICAL CONSIDERATIONS</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.1</p><p><b>text</b>: Statistical and Analytical Plans(SAP)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.2</p><p><b>text</b>: Statistical Hypotheses</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.3</p><p><b>text</b>: Analysis Datasets</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.4</p><p><b>text</b>: Populations for Analysis</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.5</p><p><b>text</b>: Sample Size Determination</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.6</p><p><b>text</b>: Description of Statistical Methods</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.7</p><p><b>text</b>: Sample Size</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p15.8</p><p><b>text</b>: Measures to Minimize Bias</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p16</p><p><b>text</b>: SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p16.1</p><p><b>text</b>: Regulatory, Ethical and Study Oversight Considerations</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p16.2</p><p><b>text</b>: Prior Approvals/Attachments Requiring Signatures</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p16.3</p><p><b>text</b>: Additional Considerations</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p16.4</p><p><b>text</b>: Abbreviations and Special Terms</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p16.5</p><p><b>text</b>: Attachments</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17</p><p><b>text</b>: STUDY ADMINISTRATION</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.1</p><p><b>text</b>: Setting</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.2</p><p><b>text</b>: Registration</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.3</p><p><b>text</b>: Resources Available</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.4</p><p><b>text</b>: IRB Review</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.5</p><p><b>text</b>: Community-Based Participatory Research/Field Research</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.6</p><p><b>text</b>: Multi Site Research</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p17.7</p><p><b>text</b>: Key Roles and Study Governance</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p18</p><p><b>text</b>: STUDY FINANCES</p><blockquote><p><b>item</b></p><p><b>linkId</b>: p18.1</p><p><b>text</b>: Funding Source</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p18.2</p><p><b>text</b>: Costs to the participant</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p18.3</p><p><b>text</b>: Participant Reimbursements or Payments</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p18.4</p><p><b>text</b>: Compensation for Research-Related Injury</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: p19</p><p><b>text</b>: REFERENCES</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td>[answer text]</td></tr></table></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-protocol-questionnaire",
"status" : "completed",
"authored" : "2021-07-23T02:13:33.336Z",
"item" : [
{
"linkId" : "p1",
"text" : "Research Study",
"item" : [
{
"linkId" : "p1.1",
"text" : "Study Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "INT",
"display" : "Interventional"
}
}
]
},
{
"linkId" : "p1.2",
"text" : "Intervention",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "DBV",
"display" : "Drug/Biologic/Vaccine"
}
}
]
},
{
"linkId" : "p1.3",
"text" : "Does this protocol require an FDA exemption?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p1.4",
"text" : "Type of exemption",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "IND",
"display" : "IND"
}
}
]
},
{
"linkId" : "p1.5",
"text" : "Study Title",
"answer" : [
{
"valueString" : "A Clinical Investigation Evaluating Efficacy of Drug A"
}
]
},
{
"linkId" : "p1.6",
"text" : "Study Title (Short)",
"answer" : [
{
"valueString" : "A Clinical Investigation Evaluating Efficacy of Drug A"
}
]
},
{
"linkId" : "p1.61",
"text" : "Principal Investigator",
"item" : [
{
"linkId" : "p1.7.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "John"
}
]
},
{
"linkId" : "p1.7.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Morrison"
}
]
},
{
"linkId" : "p1.7.7",
"text" : "Suffix",
"answer" : [
{
"valueString" : "III"
}
]
},
{
"linkId" : "p1.7.8",
"text" : "Degree(s)",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "p1.7.3",
"text" : "Department Name",
"answer" : [
{
"valueString" : "Duke University"
}
]
},
{
"linkId" : "p1.7.4",
"text" : "Address",
"item" : [
{
"linkId" : "p1.7.4.1",
"text" : "Street Address",
"answer" : [
{
"valueString" : "210 Research Drive"
}
]
},
{
"linkId" : "p1.7.4.2",
"text" : "City",
"answer" : [
{
"valueString" : "Durham"
}
]
},
{
"linkId" : "p1.7.4.3",
"text" : "State",
"answer" : [
{
"valueString" : "North Carolina"
}
]
},
{
"linkId" : "p1.7.4.4",
"text" : "Zip Code",
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"valueString" : "Maryland"
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"valueString" : "VA"
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"linkId" : "p3.1.6",
"text" : "Accrual Ceiling/Number of Participants (projected-for all sites)",
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{
"linkId" : "p3.1.7",
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"linkId" : "p3.1.8",
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"linkId" : "p3.1.10",
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{
"linkId" : "p3.1.17",
"text" : "Reference Theraphy",
"answer" : [
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{
"linkId" : "p3.1.18",
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{
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},
{
"linkId" : "p4.1.4",
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"linkId" : "p4.1.8.2",
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"answer" : [
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{
"linkId" : "p4.3.2.2",
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]
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{
"linkId" : "p4.3.3",
"text" : "Alternatives to Study Participation",
"item" : [
{
"linkId" : "p4.3.3.1",
"text" : "Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p4.3.3.2",
"text" : "Describe the standard clinical care that may be an alternative:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p4.3.3.3",
"text" : "Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p4.3.3.4",
"text" : "Other alternatives to study participation",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
}
]
},
{
"linkId" : "p5",
"text" : "STUDY PURPOSE, OBJECTIVES OR SPECIFIC AIMS",
"item" : [
{
"linkId" : "p5.1",
"text" : "Hypothesis",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p5.2",
"text" : "Primary Objectives",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p5.3",
"text" : "Secondary Objectives",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p5.4",
"text" : "Tertiary/Exploratory Objectives",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p6",
"text" : "STUDY ENDPOINTS",
"item" : [
{
"linkId" : "p6.1",
"text" : "Primary Endpoints",
"answer" : [
{
"valueString" : "[answer text]",
"item" : [
{
"linkId" : "p6.1.1",
"text" : "Justification for Endpoints",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p6.2",
"text" : "Secondary Endpoints",
"answer" : [
{
"valueString" : "[answer text]",
"item" : [
{
"linkId" : "p6.2.1",
"text" : "Justification for Secondary Endpoints",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p6.3",
"text" : "Tertiary Endpoints",
"answer" : [
{
"valueString" : "[answer text]",
"item" : [
{
"linkId" : "p6.3.1",
"text" : "Justification for Tertiary Endpoints",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p6.4",
"text" : "Primary Safety endpoints",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p6.5",
"text" : "Secondary Safety endpoints",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p6.6",
"text" : "Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p7",
"text" : "STUDY DESIGN",
"item" : [
{
"linkId" : "p7.1",
"text" : "Overall Design",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.2",
"text" : "Scientific Rationale for Study Design",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.3",
"text" : "Justification for Dose",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.4",
"text" : "Justification for Intervention",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.5",
"text" : "End of Study Definition",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.6",
"text" : "Screening Activities",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.7",
"text" : "Study Intervention Activities",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.8",
"text" : "Follow Up Activities",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.9",
"text" : "Allocation to Interventional Group",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.10",
"text" : "Study/Data Collection Instruments",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p7.11",
"text" : "Research Setting",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p8",
"text" : "STUDY POPULATION",
"item" : [
{
"linkId" : "p8.1",
"text" : "Participant Selection",
"item" : [
{
"linkId" : "p8.1.1",
"text" : "Category/Group (eg. Adults, controls, parents, children)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p8.1.2",
"text" : "Age Range",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p8.1.3",
"text" : "Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)",
"answer" : [
{
"valueInteger" : 45
}
]
},
{
"linkId" : "p8.1.4",
"text" : "Number Expected to Complete the Study or Needed to Address the Research Question",
"answer" : [
{
"valueInteger" : 200
}
]
},
{
"linkId" : "p8.1.5",
"text" : "Total Number of participants",
"answer" : [
{
"valueInteger" : 345
}
]
},
{
"linkId" : "p8.1.6",
"text" : "Overall study sample size (if multisite)",
"answer" : [
{
"valueInteger" : 345
}
]
}
]
}
]
},
{
"linkId" : "p9",
"text" : "STUDY ENROLLMENT AND WITHDRAWAL",
"item" : [
{
"linkId" : "p9.1",
"text" : "Eligibility Criteria",
"item" : [
{
"linkId" : "p9.1.1",
"text" : "Inclusion and Exclusion Criteria",
"item" : [
{
"linkId" : "p9.1.1.1",
"text" : "Inclusion Criteria",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.1.2",
"text" : "Exclusion Criteria",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p9.1.2",
"text" : "Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.3",
"text" : "State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.4",
"text" : "Can study participants participate in another research study while participating in this research study:",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.5",
"text" : "Screen Failures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.6",
"text" : "Lifestyle Considerations",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7",
"text" : "Vulnerable Populations",
"item" : [
{
"linkId" : "p9.1.7.1",
"text" : "Can or will pregnant women be enrolled",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.2",
"text" : "Enrollment of Pregnant Women",
"item" : [
{
"linkId" : "p9.1.7.2.1",
"text" : "Describe any preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, that have been conducted that provide data for assessing potential risks to pregnant women and fetuses:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.2.2",
"text" : "Are there any risk to the fetus from the study interventions or procedures.",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.2.3",
"text" : "Risks to Fetus",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.2.4",
"text" : "Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.2.5",
"text" : "Describe benefit for the women or fetus",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.2.7",
"text" : "Describe the biomedical knowledge that is expected to result from this research for this population:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.2.8",
"text" : "Describe how any risk of this research is the least possible for achieving the objectives of the research:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.2.9",
"text" : "Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p9.1.7.3",
"text" : "Can or will the research involve neonates of uncertain viability or non-viable neonates?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.31",
"text" : "Research involving neonates of uncertain viability or non-viable neonates",
"item" : [
{
"linkId" : "p9.1.7.3.1",
"text" : "Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.3.2",
"text" : "Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.3.3",
"text" : "Describe whether there will be added risk to the neonate resulting from the research",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.3.4",
"text" : "Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.3.5",
"text" : "No person shall perform or offer to perform an abortion where part or all of the consideration for said performance is that the fetal remains may be used for experimentation or other kind of research or study:",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.3.6",
"text" : "Individuals engaged in the research will have no part in determining the viability of a neonate:",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.3.7",
"text" : "For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that the research will not terminate the heartbeat or respiration of the neonate:",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.3.8",
"text" : "For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
}
]
},
{
"linkId" : "p9.1.7.4",
"text" : "Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.5",
"text" : "Enrollment of participants who are not yet adults (neonates, children, teenagers)",
"item" : [
{
"linkId" : "p9.1.7.5.1",
"text" : "I will follow the SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) to determine whether a prospective participant has or has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years).",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
},
"item" : [
{
"linkId" : "p9.1.7.5.1.1",
"text" : "If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p9.1.7.5.2",
"text" : "Describe how permission to participate in the study will be obtained from the parents or legal guardians:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3",
"text" : "Assent process of children",
"item" : [
{
"linkId" : "p9.1.7.5.3.1",
"text" : "Describe waiting period between informing the prospective participant and obtaining the assent",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.2",
"text" : "Describe any process to ensure ongoing assent",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.3",
"text" : "Describe Research team members involved in the assent process:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.4",
"text" : "Describe how long children will have to consider study participation:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.5",
"text" : "Describe steps that will be taken to minimize the possibility of coercion or undue influence:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.6",
"text" : "Describe steps that will be taken to ensure the participants's understanding:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.7",
"text" : "If assent will not be obtained from children, specify why:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.3.8",
"text" : "Will children reach 18 years of age while in the study?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.5.3.9",
"text" : "Children reaching 18 years of age while in the study",
"item" : [
{
"linkId" : "p9.1.7.5.1.9.1",
"text" : "Describe the plan to obtain written informed consent from the participant at age 18 years:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.1.9.2",
"text" : "Describe who will be responsible for managing the plan:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.1.9.3",
"text" : "Describe where the consent discussion will take place:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.5.1.9.4",
"text" : "Describe what will happen if the participant cannot be located to provide consent at age 18 years:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
}
]
},
{
"linkId" : "p9.1.7.6",
"text" : "Can or will minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.7",
"text" : "Enrollment of minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child.",
"item" : [
{
"linkId" : "p9.1.7.7.1",
"text" : "Describe how will it be determined that this population has the capacity to consent for this study. Please note that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, sound and sensitive clinical judgment that is attentive to both the minorrights and the minoractual competence and needs must be considered, and is to include a determination as to whether involvement of family or other adults familiar to the minor is necessary and appropriate:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.7.2",
"text" : "Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.7.3",
"text" : "Describe any additional steps or procedures that will be used when performing informed consent with this population:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p9.1.7.8",
"text" : "Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.9",
"text" : "Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent",
"item" : [
{
"linkId" : "p9.1.7.9.1",
"text" : "Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.2",
"text" : "Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.4",
"text" : "Describe the process to determine whether or not the individual is capable of consent:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.5",
"text" : "Describe who will determine if the participant is able to provide informed consent:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.6",
"text" : "Describe how it will be determined whether the participant is able to provide informed consent:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.7",
"text" : "Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.8",
"text" : "List the individuals from whom permission will be obtained if the participant cannot provide informed consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.9",
"text" : "If it is possible that participants may regain capacity to provide informed consent during the study, describe how frequently this will be assessed and state that participants will be consented to the study in the event that they regain capacity to provide informed consent",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.10",
"text" : "Process for assent of participants",
"item" : [
{
"linkId" : "p9.1.7.9.10.1",
"text" : "Describe whether assent will be required of all, some, or none of the participants. If some, specify which participants will be required to assent and which will not:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.10.2",
"text" : "If assent will not be obtained from some or all participants, an explanation of why not:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.10.3",
"text" : "Describe whether assent of the participants will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require participants to sign assent documents:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p9.1.7.9.11",
"text" : "Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.9.12",
"text" : "Participants will be withdrawn if they appear to be unduly distressed at any time during the study.",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
}
]
},
{
"linkId" : "p9.1.7.10",
"text" : "Can or will prisoners be enrolled?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.11",
"text" : "Enrollment of prisoners",
"item" : [
{
"linkId" : "p9.1.7.11.1",
"text" : "Describe any possible advantages accruing to the Prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.11.2",
"text" : "Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.11.3",
"text" : "Describe procedures for the selection of participants within the prison which are fair to all Prisoners and immune from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator provides to the Board justification in writing for following some other procedures, control participants must be selected randomly from the group of available Prisoners who meet the characteristics needed for that particular research project:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.11.4",
"text" : "Parole boards will not take into account a Prisoner participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.11.5",
"text" : "A letter of support from the Prison this research will be conducted in has been submitted to the IRB.",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.11.6",
"text" : "If follow-up examination or care of participants after the end of their participation is required, describe the provision for such examination or care, taking into account the varying lengths of individual Prisoners sentences, and for informing participants of this fact:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p9.1.7.12",
"text" : "Can or will students and/or employees be enrolled in this research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.13",
"text" : "Enrollment of students and/or employees",
"item" : [
{
"linkId" : "p9.1.7.13.1",
"text" : "Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.13.2",
"text" : "Describe how potential coercion will be eliminated",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.13.3",
"text" : "Describe the recruitment methods to be applied specifically to students and/or employees. If the same recruitment methods previously described in the protocol will be used, then state that:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.13.4",
"text" : "Describe additional safeguards included to protect the rights and welfare of students and employees:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.13.5",
"text" : "Describe protections to ensure that a participant's decision about participation and/or early withdrawal from the study will not affect his/her status as a student or employee:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.13.6",
"text" : "Submitted a letter from the appropriate institutional official (e.g., Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to the fact that the employeeor studentparticipation in the research is acceptable and that coercion has been minimized.",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
}
]
},
{
"linkId" : "p9.1.7.14",
"text" : "Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.15",
"text" : "Enrollment of wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody).",
"item" : [
{
"linkId" : "p9.1.7.15.1",
"text" : "Describe the justification for recruiting and enrolling this population",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.2",
"text" : "Describe any additional details about the recruitment methods to be used. If the same recruitment methods previously described in the protocol will be used, then state that:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.3",
"text" : "Describe any additional details about the informed consent process to be used. If the same informed consent process for enrolling minors previously described in the protocol will be used, then state that:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.4",
"text" : "Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.5",
"text" : "Describe how the research team will know if there has been a change in guardianship status during the course of the research and how permission will be obtained from the new guardian:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.6",
"text" : "Is the study is greater than minimal risk?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "p9.1.7.15.7",
"text" : "Greater than minimal risk study",
"item" : [
{
"linkId" : "p9.1.7.15.7.1",
"text" : "Describe whether the research is related to their status as wards OR if the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.7.2",
"text" : "Describe how an advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.7.3",
"text" : "Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.1.7.15.7.4",
"text" : "The advocate will not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
}
]
}
]
}
]
}
]
},
{
"linkId" : "p9.2",
"text" : "STRATEGIES FOR RECRUITMENT AND RETENTION",
"item" : [
{
"linkId" : "p9.2.1",
"text" : "Recruitment Methods",
"item" : [
{
"linkId" : "p9.2.1.1",
"text" : "Describe when, where, and how potential participants will be recruited",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.2.1.2",
"text" : "When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.).",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.2.1.3",
"text" : "Describe source of participants (for example, patient population, local community, etc.):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.2.1.4",
"text" : "Describe methods that will be used to identify potential participants:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p9.2.1.5",
"text" : "Describe how the recruitment methods described will be effective in attracting the targeted participant population:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p9.3",
"text" : "DURATION OF STUDY PARTICIPATION. (If there are sub-studies, include duration of participation in each sub-study.)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p10",
"text" : "STUDY INTERVENTION",
"item" : [
{
"linkId" : "p10.1",
"text" : "Study Agent",
"item" : [
{
"linkId" : "p10.1.1",
"text" : "Study Agent and Control Description",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.2",
"text" : "Receipts/Acquisition",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.3",
"text" : "Study Agent Accountability/ Return or Destruction of Investigational Product",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.4",
"text" : "Formulation and appearance of Control Product",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.5",
"text" : "Formulation and appearance of Test Product",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.6",
"text" : "Packaging and Labeling",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.7",
"text" : "Product Storage and Stability",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.8",
"text" : "Preparation",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.9",
"text" : "Administration and/or Dosing",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.10",
"text" : "Route of Administration",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.11",
"text" : "Starting Dose and Dose Escalation Schedule",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.12",
"text" : "Dose Adjustments/Modifications/Delays",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.13",
"text" : "Duration of Therapy",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.14",
"text" : "Tracking Dose",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.15",
"text" : "Device Specific Considerations",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.16",
"text" : "Administration Instructions",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.17",
"text" : "Dispensing [authority, requirements]",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.1.18",
"text" : "Supply of Study Drug at the Site",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p10.3",
"text" : "Study Procedural Intervention(s) Description",
"item" : [
{
"linkId" : "p10.3.1",
"text" : "Administration of Procedural Intervention",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.3.2",
"text" : "Procedures for Training of Clinicians on Procedural Intervention",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.3.3",
"text" : "Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p10.4",
"text" : "Participant Compliance and Monitoring",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p10.5",
"text" : "Study Intervention/Experimental Manipulation Adherence",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p11",
"text" : "STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL",
"item" : [
{
"linkId" : "p11.1",
"text" : "Discontinuation of Study Intervention",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p11.2",
"text" : "Participant withdrawal and Termination",
"item" : [
{
"linkId" : "p11.2.1",
"text" : "Reasons for Withdrawal or Termination",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p11.2.2",
"text" : "Handling of Participant Withdrawal or Termination",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p11.2.3",
"text" : "Replacement of participants",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p11.3",
"text" : "Lost to Follow-Up",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p12",
"text" : "STUDY PROCEDURES",
"item" : [
{
"linkId" : "p12.1",
"text" : "Study Procedures/Evaluations",
"item" : [
{
"linkId" : "p12.1.1",
"text" : "Study Specific Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.1.2",
"text" : "Standard of Care Study Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p12.2",
"text" : "Laboratory Procedures/Evaluations",
"item" : [
{
"linkId" : "p12.2.1",
"text" : "Clinical Laboratory Evaluations",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.2.2",
"text" : "Research Laboratory Evaluations",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.2.3",
"text" : "Other Assays or Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.2.4",
"text" : "Specimen Preparation, Handling, and Storage",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.2.5",
"text" : "Specimen Shipment",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p12.3",
"text" : "Data Collection and Follow Up for Withdrawn participants",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.4",
"text" : "Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.5",
"text" : "Precautionary Medications, Treatments, and Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.6",
"text" : "Prohibited Medications, Treatments, and Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.7",
"text" : "Prophylactic Medications, Treatments, and Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.8",
"text" : "Rescue Medications, Treatments, and Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.9",
"text" : "Participant Access to Study Agent at Study Closure",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p12.10",
"text" : "Concomitant Medications, Treatments , and Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p13",
"text" : "SCHEDULE OF STUDY PROCEDURES",
"item" : [
{
"linkId" : "p13.1",
"text" : "Screening",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.2",
"text" : "Enrollment/Visit 1/Baseline Visit",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.3",
"text" : "Intermediate Visits",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.4",
"text" : "Final Study Visit",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.5",
"text" : "Withdrawal/Early Termination Visit",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.6",
"text" : "Unscheduled Visit",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.7",
"text" : "Follow Up Phase of the Study",
"item" : [
{
"linkId" : "p13.7.1",
"text" : "Visit",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p13.7.2",
"text" : "End of Study Visit",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p14",
"text" : "ASSESSMENT OF SAFETY",
"item" : [
{
"linkId" : "p14.1",
"text" : "Specification of Safety Parameters",
"item" : [
{
"linkId" : "p14.1.1",
"text" : "Definition of Adverse Events(AE)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.1.2",
"text" : "Definition of Serious Adverse Events (SAE)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.1.3",
"text" : "Definition of Unanticipated Problems",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p14.2",
"text" : "Classification of an Adverse Event",
"item" : [
{
"linkId" : "p14.2.1",
"text" : "Severity of an Event",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.2.2",
"text" : "Relationship to Study Intervention/Experimental Manipulation",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.2.3",
"text" : "Expectedness",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p14.3",
"text" : "Time Period and Frequencey for Event Assessment and Follow-Up",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.4",
"text" : "Reporting Procedures",
"item" : [
{
"linkId" : "p14.4.1",
"text" : "Notifying the IRB",
"item" : [
{
"linkId" : "p14.4.1.1",
"text" : "Adverse Event Reporting",
"answer" : [
{
"valueString" : "[answer text]"
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},
{
"linkId" : "p14.4.1.2",
"text" : "Serious Adverse Event Reporting",
"answer" : [
{
"valueString" : "[answer text]"
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},
{
"linkId" : "p14.4.1.3",
"text" : "Unanticipated Problem Reporting",
"answer" : [
{
"valueString" : "[answer text]"
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},
{
"linkId" : "p14.4.1.4",
"text" : "Reporting of Pregnancy",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
},
{
"linkId" : "p14.4.2",
"text" : "Notifyiing the Study Sponsor",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.4.3",
"text" : "Notifying the FDA",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.4.4",
"text" : "Notifying Participating Investigators",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.4.5",
"text" : "Reporting Events to Participants",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p14.4.6",
"text" : "Events of Special Interest",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
},
{
"linkId" : "p14.5",
"text" : "Follow Up Report",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p14.6",
"text" : "Study Halting/Stopping Rules",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p15",
"text" : "STATISTICAL CONSIDERATIONS",
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{
"linkId" : "p15.1",
"text" : "Statistical and Analytical Plans(SAP)",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p15.2",
"text" : "Statistical Hypotheses",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.3",
"text" : "Analysis Datasets",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.4",
"text" : "Populations for Analysis",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.5",
"text" : "Sample Size Determination",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6",
"text" : "Description of Statistical Methods",
"item" : [
{
"linkId" : "p15.6.1",
"text" : "General Approach",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p15.6.2",
"text" : "Analysis of Primary Efficacy Endpoints(s)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.3",
"text" : "Analysis of Secondary Endpoint(s)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.4",
"text" : "Safety Analyses",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.5",
"text" : "Adherence and Retention Analyses",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p15.6.6",
"text" : "Baseline Descriptive Statistics",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p15.6.7",
"text" : "Planned Interim Analyses",
"item" : [
{
"linkId" : "p15.6.7.1",
"text" : "Safety Review",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p15.6.7.2",
"text" : "Efficacy Review",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
},
{
"linkId" : "p15.6.8",
"text" : "Additional Sub-Group Analyses",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.9",
"text" : "Multiple Comparison/Multiplicity",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.10",
"text" : "Tabulation of Individual Response Data",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.11",
"text" : "Exploratory Analyses",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.6.12",
"text" : "Pharmacokinetic Analysis (if applicable)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p15.7",
"text" : "Sample Size",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.8",
"text" : "Measures to Minimize Bias",
"item" : [
{
"linkId" : "p15.8.1",
"text" : "Enrollment/Randomization/Masking Procedures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.8.2",
"text" : "Evaluation of Success of Blinding",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p15.8.3",
"text" : "Breaking the Study Blind/Participant Code",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p16",
"text" : "SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS",
"item" : [
{
"linkId" : "p16.1",
"text" : "Regulatory, Ethical and Study Oversight Considerations",
"item" : [
{
"linkId" : "p16.1.1",
"text" : "Protocol Amendments",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.2",
"text" : "Ethical Standard",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.3",
"text" : "Institutional Review Board",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.4",
"text" : "Informed Consent Process",
"item" : [
{
"linkId" : "p16.1.4.1",
"text" : "Consent/Assent and Other Informational Documents Provided to Participants",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.4.2",
"text" : "Consent Procedures and Documentation",
"item" : [
{
"linkId" : "p16.1.4.2.1",
"text" : "Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.4.2.2",
"text" : "Describe the parental permission process and the child assent process. (If study involves children)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.4.2.3",
"text" : "Some participants may be vulnerable to coercion or undue influence, such as those who are economically or educationally disadvantaged, mentally disabled, or students (undergraduate, graduate, and medical students) and employees (administrative, clerical, nursing, lab technicians, post-doctoral fellows and house staff, etc.), describe the procedures to ensure the voluntary participation of these individuals",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.4.2.4",
"text" : "Methods of Informed Consent for non-English Speakers",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.1.4.2.5",
"text" : "Waiver or Alteration of Consent Process",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.4.2.6",
"text" : "HIPAA Authorization",
"item" : [
{
"linkId" : "p16.1.4.2.7.1",
"text" : "Participant's Capacity to Give Legally Effective Consent",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
}
]
},
{
"linkId" : "p16.1.4.3",
"text" : "Indicate where the consent process will take place.",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p16.1.5",
"text" : "Participant data and Confidentialty",
"item" : [
{
"linkId" : "p16.1.5.1",
"text" : "Research Use of Stored Human Samples, Specimens, or Data",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.5.2",
"text" : "Confidentiality of Research Biospeciemen/Data",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.1.5.3",
"text" : "Certificate of Confidentiality (if applicable)",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.5.4",
"text" : "Provisions to Protect the Privacy of Participants:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p16.1.6",
"text" : "Future Use of Stored Human Specimens and Data",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.7",
"text" : "Study Discontinuation and Closure",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.8",
"text" : "Key Roles and Expertise of Study Team",
"item" : [
{
"linkId" : "p16.1.8.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.8.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.8.3",
"text" : "Position/Title",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.8.4",
"text" : "Responsibilities",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p16.1.8",
"text" : "Key Roles and Expertise of Study Team",
"item" : [
{
"linkId" : "p16.1.8.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.1.8.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.8.3",
"text" : "Position/Title",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.8.4",
"text" : "Responsibilities",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
},
{
"linkId" : "p16.1.9",
"text" : "Safety Oversight",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.1.10",
"text" : "Clinical Monitoring",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.11",
"text" : "Quality Assurance and Quality Control",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.12",
"text" : "Data Handling and Record Keeping",
"item" : [
{
"linkId" : "p16.1.12.1",
"text" : "Data Quality Control and Reporting",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.12.2",
"text" : "Data Collection and Management Responsibilities",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.12.3",
"text" : "Data Archival",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.12.4",
"text" : "Study Records Retention",
"item" : [
{
"linkId" : "p16.1.12.4.1",
"text" : "Photographs, Audio/Video Recordings Retention",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.12.4.2",
"text" : "Data and/or Biological Specimens Access",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.1.12.4.3",
"text" : "Data and/or Biological Specimens Retention/Banking",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
}
]
},
{
"linkId" : "p16.1.13",
"text" : "Protocol Deviations",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.14",
"text" : "Publication and Data Sharing Policy",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.15",
"text" : "Conflict of Interest Policy",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.16",
"text" : "Source Documents and Access to Source Data/Documents",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.1.17",
"text" : "Collections of Photographs, or Audio/Video Recording",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p16.2",
"text" : "Prior Approvals/Attachments Requiring Signatures",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p16.3",
"text" : "Additional Considerations",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.4",
"text" : "Abbreviations and Special Terms",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p16.5",
"text" : "Attachments",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
},
{
"linkId" : "p17",
"text" : "STUDY ADMINISTRATION",
"item" : [
{
"linkId" : "p17.1",
"text" : "Setting",
"item" : [
{
"linkId" : "p17.1.1",
"text" : "Describe the sites / locations where your research team will conduct the research:",
"answer" : [
{
"valueString" : "[answer text]"
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]
}
]
},
{
"linkId" : "p17.2",
"text" : "Registration",
"item" : [
{
"linkId" : "p17.2.1",
"text" : "Describe the steps the research team will take to ensure that a participant is appropriately enrolled or registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol eligibility checklist that will be used, specify who on the research team will confirm eligibility and that consent was documented, etc.):",
"answer" : [
{
"valueString" : "[answer text]"
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},
{
"linkId" : "p17.3",
"text" : "Resources Available",
"item" : [
{
"linkId" : "p17.3.1",
"text" : "Describe the roles/tasks of each research team member",
"answer" : [
{
"valueString" : "[answer text]"
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},
{
"linkId" : "p17.3.2",
"text" : "Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. Provide enough information for the IRB to determine the PI and research team are qualified to conduct the proposed research. Alternatively, you can submit the current CVs for the research team instead:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.3.3",
"text" : "Describe the coverage plan to address any issues (including participant safety issues) that occur while the PI is away and/or unavailable. The research team member designated to serve as the acting PI in the PIabsence should have similar training and expertise as the PI:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.3.4",
"text" : "Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.3.5",
"text" : "Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study?",
"answer" : [
{
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"display" : "Yes"
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{
"linkId" : "p17.4",
"text" : "IRB Review",
"item" : [
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"linkId" : "p17.4.1",
"text" : "An appropriate IRB , registered with the OHRP ,review and approve this study.",
"answer" : [
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"code" : "Y",
"display" : "Yes"
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},
{
"linkId" : "p17.4.2",
"text" : "Any amendments to the protocol or informed consent documents will be reviewed and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to participants?",
"answer" : [
{
"valueCoding" : {
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"code" : "Y",
"display" : "Yes"
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},
{
"linkId" : "p17.5",
"text" : "Community-Based Participatory Research/Field Research",
"item" : [
{
"linkId" : "p17.5.1",
"text" : "Can or will this study involve community-based participatory research?",
"answer" : [
{
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"code" : "Y",
"display" : "Yes"
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},
{
"linkId" : "p17.5.2",
"text" : "Community-based participatory research",
"item" : [
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"linkId" : "p17.5.2.1",
"text" : "Describe the communities that will be involved in this research:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.5.2.2",
"text" : "Describe the composition and involvement of any community advisory board:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.5.2.3",
"text" : "Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.5.2.4",
"text" : "Describe the plans on dissemination and publication of study results which are in agreement with the community:",
"answer" : [
{
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},
{
"linkId" : "p17.6",
"text" : "Multi Site Research",
"item" : [
{
"linkId" : "p17.6.1",
"text" : "Describe the plan for tracking IRB approval of documents and consent forms for each site:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.2",
"text" : "Name of the sponsor and Contract Research Organization (CRO):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.3",
"text" : "Describe the training that will be provided to the enrolling sites staff prior to protocol implementation at that study site and throughout the course of the study. Include the type of training, e.g., study meetings, teleconferences, etc., as well as who will provide the training and how it will be documented:",
"answer" : [
{
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}
]
},
{
"linkId" : "p17.6.4",
"text" : "Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.6.5",
"text" : "Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.6",
"text" : "Describe the plan for collection and management of data from all sites. Specify if data will be shared outside (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how data will be received from and distributed to other sites as needed). If available, please provide the Data Sharing Plan or Policy:",
"answer" : [
{
"valueString" : "[answer text]"
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]
},
{
"linkId" : "p17.6.7",
"text" : "Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations:",
"item" : [
{
"linkId" : "p17.6.7.1",
"text" : "Describe how the Coordinating Center will monitor each site's study conduct during the different phases of the study (e.g. remotely, in-person visits, reports, etc.):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.7.2",
"text" : "Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p17.6.8",
"text" : "Describe the plan for processing, reporting and evaluating unanticipated problems, protocol violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies (e.g. FDA):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.9",
"text" : "Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable):",
"item" : [
{
"linkId" : "p17.6.9.1",
"text" : "Describe how they will be provided to each enrolling site:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.9.2",
"text" : "Describe how dispensing will be monitored:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.9.3",
"text" : "Describe what investigational product accountability procedures will be implemented:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p17.6.10",
"text" : "Describe the procedures for study closures and early site termination:",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p17.6.11",
"text" : "Describe any collaborations not described above, such as [institution] investigators with multiple affiliations that would engage other institutions in research (e.g., [institution] is paying another institution for the research, the research is being conducted on behalf of another institution):",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p17.7",
"text" : "Key Roles and Study Governance",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p18",
"text" : "STUDY FINANCES",
"item" : [
{
"linkId" : "p18.1",
"text" : "Funding Source",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p18.2",
"text" : "Costs to the participant",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p18.3",
"text" : "Participant Reimbursements or Payments",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "p18.4",
"text" : "Compensation for Research-Related Injury",
"answer" : [
{
"valueString" : "[answer text]"
}
]
}
]
},
{
"linkId" : "p19",
"text" : "REFERENCES",
"answer" : [
{
"valueString" : "[answer text]"
}
]
},
{
"linkId" : "ADMIN00",
"text" : "Administrative Use Only",
"item" : [
{
"linkId" : "ADMIN01",
"text" : "Link ID prefix",
"answer" : [
{
"valueString" : "p"
}
]
}
]
}
]
}
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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