Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
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<div xmlns="http://www.w3.org/1999/xhtml"><p><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>
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<linkId value="p1"/>
<text value="Research Study"/>
<item>
<linkId value="p1.1"/>
<text value="Study Type"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="INT"/>
<display value="Interventional"/>
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<linkId value="p1.2"/>
<text value="Intervention"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="DBV"/>
<display value="Drug/Biologic/Vaccine"/>
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</answer>
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<item>
<linkId value="p1.3"/>
<text value="Does this protocol require an FDA exemption?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p1.4"/>
<text value="Type of exemption"/>
<answer>
<valueCoding>
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<code value="IND"/>
<display value="IND"/>
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<item>
<linkId value="p1.5"/>
<text value="Study Title"/>
<answer>
<valueString
value="A Clinical Investigation Evaluating Efficacy of Drug A"/>
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<item>
<linkId value="p1.6"/>
<text value="Study Title (Short)"/>
<answer>
<valueString
value="A Clinical Investigation Evaluating Efficacy of Drug A"/>
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<item>
<linkId value="p1.61"/>
<text value="Principal Investigator"/>
<item>
<linkId value="p1.7.1"/>
<text value="First Name"/>
<answer>
<valueString value="John"/>
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<item>
<linkId value="p1.7.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Morrison"/>
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<text value="Suffix"/>
<answer>
<valueString value="III"/>
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<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
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<text value="Department Name"/>
<answer>
<valueString value="Duke University"/>
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<linkId value="p1.7.4"/>
<text value="Address"/>
<item>
<linkId value="p1.7.4.1"/>
<text value="Street Address"/>
<answer>
<valueString value="210 Research Drive"/>
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<item>
<linkId value="p1.7.4.2"/>
<text value="City"/>
<answer>
<valueString value="Durham"/>
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</item>
<item>
<linkId value="p1.7.4.3"/>
<text value="State"/>
<answer>
<valueString value="North Carolina"/>
</answer>
</item>
<item>
<linkId value="p1.7.4.4"/>
<text value="Zip Code"/>
<answer>
<valueString value="27612"/>
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<item>
<linkId value="p1.7.4.5"/>
<text value="Country"/>
<answer>
<valueString value="USA"/>
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<item>
<linkId value="p1.7.5"/>
<text value="Phone"/>
<answer>
<valueString value="9198723456"/>
</answer>
</item>
<item>
<linkId value="p1.7.6"/>
<text value="Email"/>
<answer>
<valueString value="john.morrisoon@duke.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="p1.7"/>
<text value="Additional Investigator"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p1.8"/>
<text value="Additional Investigator"/>
<item>
<linkId value="p1.8.1"/>
<text value="Additional Investigator Role"/>
<answer>
<valueCoding>
<system
value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="COPI"/>
<display value="Co-Principal Investigator"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p1.8.2"/>
<text value="First Name"/>
<answer>
<valueString value="John"/>
</answer>
</item>
<item>
<linkId value="p1.8.3"/>
<text value="Last Name"/>
<answer>
<valueString value="Blake"/>
</answer>
</item>
<item>
<linkId value="p1.8.9"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="p1.8.4"/>
<text value="Department Name"/>
<answer>
<valueString value="Nurobiology"/>
</answer>
</item>
<item>
<linkId value="p1.8.5"/>
<text value="Address"/>
<item>
<linkId value="p1.8.5.1"/>
<text value="Street Address"/>
<answer>
<valueString value="210 Research Drive"/>
</answer>
</item>
<item>
<linkId value="p1.8.5.2"/>
<text value="City"/>
<answer>
<valueString value="Durham"/>
</answer>
</item>
<item>
<linkId value="p1.8.5.3"/>
<text value="State"/>
<answer>
<valueString value="NC"/>
</answer>
</item>
<item>
<linkId value="p1.8.5.4"/>
<text value="Zip Code"/>
<answer>
<valueString value="27703"/>
</answer>
</item>
<item>
<linkId value="p1.8.5.5"/>
<text value="Country"/>
<answer>
<valueString value="USA"/>
</answer>
</item>
</item>
<item>
<linkId value="p1.8.6"/>
<text value="Phone"/>
<answer>
<valueString value="9197865645"/>
</answer>
</item>
<item>
<linkId value="p1.8.7"/>
<text value="Email"/>
<answer>
<valueString value="blake001@duke.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="p1.9"/>
<text value="IRB Protocol Number"/>
<answer>
<valueString value="PRO0923456"/>
</answer>
</item>
<item>
<linkId value="p1.10"/>
<text value="Sponsor Protocol Number"/>
<answer>
<valueString value="XYXry7865"/>
</answer>
</item>
<item>
<linkId value="p1.11"/>
<text value="ClinicalTrials.Gov Identifier"/>
<answer>
<valueString value="NCT56789098"/>
</answer>
</item>
<item>
<linkId value="p1.14"/>
<text value="IND Number"/>
<answer>
<valueString value="432fdw512432fqsdf"/>
</answer>
</item>
<item>
<linkId value="p1.16"/>
<text value="Study Product Name"/>
<answer>
<valueString value="Product A"/>
</answer>
</item>
<item>
<linkId value="p1.17"/>
<text value="Study Product Provider"/>
<answer>
<valueString value="Bohimia Labs"/>
</answer>
</item>
<item>
<linkId value="p1.18"/>
<text value="Funding Organization"/>
<item>
<linkId value="p1.18.1"/>
<text value="Name"/>
<answer>
<valueString value="NIH"/>
</answer>
</item>
<item>
<linkId value="p1.18.2"/>
<text value="Address"/>
<item>
<linkId value="p1.18.2.1"/>
<text value="Street Address"/>
<answer>
<valueString value="NIH Street"/>
</answer>
</item>
<item>
<linkId value="p1.18.2.2"/>
<text value="City"/>
<answer>
<valueString value="Silver Spring"/>
</answer>
</item>
<item>
<linkId value="p1.18.2.3"/>
<text value="State"/>
<answer>
<valueString value="Maryland"/>
</answer>
</item>
<item>
<linkId value="p1.18.2.4"/>
<text value="Zip Code"/>
<answer>
<valueString value="34567"/>
</answer>
</item>
</item>
<item>
<linkId value="p1.18.3"/>
<text value="Phone Number"/>
<answer>
<valueString value="2027861789"/>
</answer>
</item>
</item>
<item>
<linkId value="p1.19"/>
<text value="Sponsor"/>
<item>
<linkId value="p1.19.1"/>
<text value="Name"/>
<answer>
<valueString value="Jeresen Pahrmaceutical"/>
</answer>
</item>
<item>
<linkId value="p1.19.3"/>
<text value="Address"/>
<item>
<linkId value="p1.19.3.1"/>
<text value="Street Address"/>
<answer>
<valueString value="230 Anderson St"/>
<item>
<linkId value="p1.19.3.1.1"/>
<text value="City"/>
<answer>
<valueString value="Durham"/>
</answer>
</item>
<item>
<linkId value="p1.19.3.1.2"/>
<text value="State"/>
<answer>
<valueString value="NC"/>
</answer>
</item>
<item>
<linkId value="p1.19.3.1.3"/>
<text value="Zip Code"/>
<answer>
<valueString value="26756"/>
</answer>
</item>
<item>
<linkId value="p1.19.3.1.4"/>
<text value="Country"/>
<answer>
<valueString value="USA"/>
</answer>
</item>
</answer>
</item>
</item>
<item>
<linkId value="p1.19.4"/>
<text value="Email"/>
<answer>
<valueString value="jersen@jersen.com"/>
</answer>
</item>
<item>
<linkId value="p1.19.5"/>
<text value="Phone Number"/>
<answer>
<valueString value="786-098-1234"/>
</answer>
</item>
</item>
<item>
<linkId value="p1.20"/>
<text value="Medical Monitor"/>
<item>
<linkId value="p1.20.1"/>
<text value="Given Name"/>
<answer>
<valueString value="Anderson"/>
</answer>
</item>
<item>
<linkId value="p1.20.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Johnson"/>
</answer>
</item>
<item>
<linkId value="p1.20.7"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="p1.20.3"/>
<text value="Phone Number"/>
<answer>
<valueString value="897-109-2345"/>
</answer>
</item>
<item>
<linkId value="p1.20.4"/>
<text value="Email"/>
<answer>
<valueString value="johnson@duke.edu"/>
</answer>
</item>
<item>
<linkId value="p1.20.5"/>
<text value="Address"/>
<item>
<linkId value="p1.20.5.1"/>
<text value="Street Address"/>
<answer>
<valueString value="123 Some Street"/>
</answer>
</item>
<item>
<linkId value="p1.20.5.2"/>
<text value="City"/>
<answer>
<valueString value="Arlington"/>
</answer>
</item>
<item>
<linkId value="p1.20.5.3"/>
<text value="State"/>
<answer>
<valueString value="VA"/>
</answer>
</item>
<item>
<linkId value="p1.20.5.4"/>
<text value="Zip Code"/>
<answer>
<valueString value="34567"/>
</answer>
</item>
<item>
<linkId value="p1.20.5.5"/>
<text value="Country"/>
<answer>
<valueString value="USA"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p1.21"/>
<text value="Confidentialty Statement"/>
<answer>
<valueString
value="This material is confidential and the property of Sponsor. Its contents must not be disclosed or used except as authorized in writing by Sponsor."/>
</answer>
</item>
<item>
<linkId value="p1.22"/>
<text value="Investigator's Signature"/>
<answer>
<valueString value="Signature on file"/>
</answer>
</item>
<item>
<linkId value="p1.23"/>
<text value="Protocol Version Number"/>
<answer>
<valueString value="1.0"/>
</answer>
</item>
<item>
<linkId value="p1.24"/>
<text value="Protocol Version Date"/>
<answer>
<valueDate value="2021-07-22"/>
</answer>
</item>
</item>
<item>
<linkId value="p2.4"/>
<text value="Statement of Compliance"/>
<answer>
<valueString
value="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."/>
</answer>
</item>
<item>
<linkId value="p3"/>
<text value="Protocol Summary"/>
<item>
<linkId value="p3.1"/>
<text value="Synopsis"/>
<item>
<linkId value="p3.1.1"/>
<text value="Title (Full)"/>
<answer>
<valueString
value="A Clinical Investigation Evaluating Efficacy of Device A"/>
</answer>
</item>
<item>
<linkId value="p3.1.2"/>
<text value="Title (Short)"/>
<answer>
<valueString
value="A Clinical Investigation Evaluating Efficacy of Device A"/>
</answer>
</item>
<item>
<linkId value="p3.1.3"/>
<text value="Study Description"/>
<answer>
<valueString value="Study Description goes here"/>
</answer>
</item>
<item>
<linkId value="p3.1.4"/>
<text value="Objectives"/>
<answer>
<valueString
value="To explorate the safety and efficacy of TJ301 in patients with active ulcerative colitis"/>
</answer>
</item>
<item>
<linkId value="p3.1.5"/>
<text value="End Points"/>
<answer>
<valueString
value="Clinical and endoscopic remission at Week 12, defined as a full Mayo score ≤2, no
individual subscore >1, rectal bleeding subscore = 0"/>
</answer>
</item>
<item>
<linkId value="p3.1.6"/>
<text
value="Accrual Ceiling/Number of Participants (projected-for all sites)"/>
<answer>
<valueInteger value="345"/>
</answer>
</item>
<item>
<linkId value="p3.1.7"/>
<text value="Study Population"/>
<answer>
<valueString
value="Male and female patients 18-70 (inclusive) years of age."/>
</answer>
</item>
<item>
<linkId value="p3.1.8"/>
<text value="Phase"/>
<answer>
<valueCoding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
<code value="phase-3"/>
<display value="Phase 3"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p3.1.9"/>
<text value="Description of Sites/Facilities Enrolling Participants"/>
<answer>
<valueString
value="Multicenter, international, across Mainland China,
Taiwan, Republic of Korea and Australia"/>
</answer>
</item>
<item>
<linkId value="p3.1.10"/>
<text
value="Description of Study Intervention ( Agent/Procedure)/Investigational Product"/>
<answer>
<valueString
value="The IMP in this trial is TJ301 (FE 999301, Olamkicept (proposed INN)) (15 mg/mL in solution for
injection [25 mM histidine, 200 mM sucrose, 0.1 mg/mL Polysorbate 20 in aqueous solution]). The
placebo is the solution for injection [25 mM histidine, 200 mM sucrose, 0.1 mg/mL Polysorbate 20
in aqueous solution] without TJ301."/>
</answer>
</item>
<item>
<linkId value="p3.1.11"/>
<text value="Study Duration"/>
<answer>
<valueString value="60 months"/>
</answer>
</item>
<item>
<linkId value="p3.1.12"/>
<text value="Participant Duration"/>
<answer>
<valueString value="48 months"/>
</answer>
</item>
<item>
<linkId value="p3.1.13"/>
<text value="Methodology"/>
<answer>
<valueString
value="This is a multicenter, randomized, double-blind, placebo-controlled phase II study"/>
</answer>
</item>
<item>
<linkId value="p3.1.14"/>
<text value="Duration of Investigational Product Administration"/>
<answer>
<valueString value="3 months"/>
</answer>
</item>
<item>
<linkId value="p3.1.15"/>
<text value="Key Procedures"/>
<answer>
<valueString value="IV Administration of Drug"/>
</answer>
</item>
<item>
<linkId value="p3.1.16"/>
<text value="Main Inclusion/Exclusion Criteria"/>
<answer>
<valueString
value="Inclusion Criterea: Active UC with a full Mayo score≥5 and a rectal bleeding subscore ≥1 at screening
Exclusion Criterea: Pregnant or breastfeeding women"/>
</answer>
</item>
<item>
<linkId value="p3.1.17"/>
<text value="Reference Theraphy"/>
<answer>
<valueString value="N/A"/>
</answer>
</item>
<item>
<linkId value="p3.1.18"/>
<text value="Statistical Analysis"/>
<answer>
<valueString
value="A sample size of N=72 (n=24 per treatment/placebo arm) patients is expected to achieve a power of
83% of detecting a trend (p<0.05, one-sided) if the true remission rate difference (at Week 12)
between the placebo and highest dose groups (600 mg Q2W) is 30% (10% for the placebo and 40%
for the highest dose) using Pearson’s chi-square test without continuity correction."/>
</answer>
</item>
</item>
<item>
<linkId value="p3.2"/>
<text value="Schema"/>
</item>
<item>
<linkId value="p3.3"/>
<text value="Schedule of Activities"/>
</item>
</item>
<item>
<linkId value="p4"/>
<text value="INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONAL"/>
<item>
<linkId value="p4.1"/>
<text value="Background"/>
<item>
<linkId value="p4.1.1"/>
<text
value="Describe the relevant literature and the specific gaps in current knowledge that this study intends to address"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.2"/>
<text
value="Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.3"/>
<text value="Describe the relevance and usefulness of the objectives"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.4"/>
<text
value="Is this the first time the study drug, device, or intervention/procedure will be used in humans."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p4.1.6"/>
<text value="Investigational Product"/>
<item>
<linkId value="p4.1.6.1"/>
<text value="Name and Description"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.6.2"/>
<text value="Preclinical Data"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.6.3"/>
<text value="Clinical Data to Date"/>
<item>
<linkId value="p4.1.6.3.1"/>
<text value="Human Pharmacokinetics"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.6.3.2"/>
<text value="Clinical Studies in adults"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.1.6.3.3"/>
<text value="Clinical Studies in Children"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p4.1.7"/>
<text value="Is there an active control group?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p4.1.8"/>
<text value="Active Control Group"/>
<item>
<linkId value="p4.1.8.1"/>
<text
value="Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment:"/>
<answer>
<valueString value="Test"/>
</answer>
</item>
<item>
<linkId value="p4.1.8.2"/>
<text
value="Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p4.1.8.3"/>
<text
value="Is the active control an established effective intervention?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p4.2"/>
<text value="Study Rationale"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3"/>
<text value="Risk/Benefit Assessment"/>
<item>
<linkId value="p4.3.1"/>
<text value="Potential Risks"/>
<item>
<linkId value="p4.3.1.1"/>
<text
value="List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the participants related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.1.2"/>
<text value="State which study interventions may have unknown risks:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.1.3"/>
<text
value="State which study interventions may have risks to an embryo or fetus (if a participant is or becomes pregnant) or to a nursing infant of a study participant:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.1.4"/>
<text
value="Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.1.5"/>
<text
value="Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p4.3.1.6"/>
<text
value="Risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):"/>
<item>
<linkId value="p4.3.1.6.1"/>
<text value="Describe these risks"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.1.6.2"/>
<text
value="Describe the procedures that will be put in place to minimize these risks:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.1.6.3"/>
<text
value="Describe how these procedures are adequate for the location where study procedures will be performed:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p4.3.1.7"/>
<text value="Other risks"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p4.3.2"/>
<text value="Potential Benefits"/>
<item>
<linkId value="p4.3.2.1"/>
<text
value="Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.2.2"/>
<text
value="Describe any benefit to the population from which the participant is drawn:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.2.3"/>
<text
value="Describe any benefit to science, society, and humanity in general:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.2.4"/>
<text value="Other benefits"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p4.3.3"/>
<text value="Alternatives to Study Participation"/>
<item>
<linkId value="p4.3.3.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.3.2"/>
<text
value="Describe the standard clinical care that may be an alternative:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.3.3"/>
<text
value="Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p4.3.3.4"/>
<text value="Other alternatives to study participation"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
</item>
<item>
<linkId value="p5"/>
<text value="STUDY PURPOSE, OBJECTIVES OR SPECIFIC AIMS"/>
<item>
<linkId value="p5.1"/>
<text value="Hypothesis"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p5.2"/>
<text value="Primary Objectives"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p5.3"/>
<text value="Secondary Objectives"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p5.4"/>
<text value="Tertiary/Exploratory Objectives"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p6"/>
<text value="STUDY ENDPOINTS"/>
<item>
<linkId value="p6.1"/>
<text value="Primary Endpoints"/>
<answer>
<valueString value="[answer text]"/>
<item>
<linkId value="p6.1.1"/>
<text value="Justification for Endpoints"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</answer>
</item>
<item>
<linkId value="p6.2"/>
<text value="Secondary Endpoints"/>
<answer>
<valueString value="[answer text]"/>
<item>
<linkId value="p6.2.1"/>
<text value="Justification for Secondary Endpoints"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</answer>
</item>
<item>
<linkId value="p6.3"/>
<text value="Tertiary Endpoints"/>
<answer>
<valueString value="[answer text]"/>
<item>
<linkId value="p6.3.1"/>
<text value="Justification for Tertiary Endpoints"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</answer>
</item>
<item>
<linkId value="p6.4"/>
<text value="Primary Safety endpoints"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p6.5"/>
<text value="Secondary Safety endpoints"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p6.6"/>
<text
value="Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims."/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p7"/>
<text value="STUDY DESIGN"/>
<item>
<linkId value="p7.1"/>
<text value="Overall Design"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.2"/>
<text value="Scientific Rationale for Study Design"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.3"/>
<text value="Justification for Dose"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.4"/>
<text value="Justification for Intervention"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.5"/>
<text value="End of Study Definition"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.6"/>
<text value="Screening Activities"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.7"/>
<text value="Study Intervention Activities"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.8"/>
<text value="Follow Up Activities"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.9"/>
<text value="Allocation to Interventional Group"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.10"/>
<text value="Study/Data Collection Instruments"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p7.11"/>
<text value="Research Setting"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p8"/>
<text value="STUDY POPULATION"/>
<item>
<linkId value="p8.1"/>
<text value="Participant Selection"/>
<item>
<linkId value="p8.1.1"/>
<text value="Category/Group (eg. Adults, controls, parents, children)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p8.1.2"/>
<text value="Age Range"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p8.1.3"/>
<text
value="Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)"/>
<answer>
<valueInteger value="45"/>
</answer>
</item>
<item>
<linkId value="p8.1.4"/>
<text
value="Number Expected to Complete the Study or Needed to Address the Research Question"/>
<answer>
<valueInteger value="200"/>
</answer>
</item>
<item>
<linkId value="p8.1.5"/>
<text value="Total Number of participants"/>
<answer>
<valueInteger value="345"/>
</answer>
</item>
<item>
<linkId value="p8.1.6"/>
<text value="Overall study sample size (if multisite)"/>
<answer>
<valueInteger value="345"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p9"/>
<text value="STUDY ENROLLMENT AND WITHDRAWAL"/>
<item>
<linkId value="p9.1"/>
<text value="Eligibility Criteria"/>
<item>
<linkId value="p9.1.1"/>
<text value="Inclusion and Exclusion Criteria"/>
<item>
<linkId value="p9.1.1.1"/>
<text value="Inclusion Criteria"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.1.2"/>
<text value="Exclusion Criteria"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.2"/>
<text
value="Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination):"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.4"/>
<text
value="Can study participants participate in another research study while participating in this research study:"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.5"/>
<text value="Screen Failures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.6"/>
<text value="Lifestyle Considerations"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7"/>
<text value="Vulnerable Populations"/>
<item>
<linkId value="p9.1.7.1"/>
<text value="Can or will pregnant women be enrolled"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.2"/>
<text value="Enrollment of Pregnant Women"/>
<item>
<linkId value="p9.1.7.2.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.2"/>
<text
value="Are there any risk to the fetus from the study interventions or procedures."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.3"/>
<text value="Risks to Fetus"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.4"/>
<text
value="Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.5"/>
<text value="Describe benefit for the women or fetus"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.7"/>
<text
value="Describe the biomedical knowledge that is expected to result from this research for this population:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.8"/>
<text
value="Describe how any risk of this research is the least possible for achieving the objectives of the research:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.2.9"/>
<text
value="Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.3"/>
<text
value="Can or will the research involve neonates of uncertain viability or non-viable neonates?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.31"/>
<text
value="Research involving neonates of uncertain viability or non-viable neonates"/>
<item>
<linkId value="p9.1.7.3.1"/>
<text
value="Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.2"/>
<text
value="Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.3"/>
<text
value="Describe whether there will be added risk to the neonate resulting from the research"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.4"/>
<text
value="Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.5"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.6"/>
<text
value="Individuals engaged in the research will have no part in determining the viability of a neonate:"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.7"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.3.8"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.4"/>
<text
value="Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.5"/>
<text
value="Enrollment of participants who are not yet adults (neonates, children, teenagers)"/>
<item>
<linkId value="p9.1.7.5.1"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
<item>
<linkId value="p9.1.7.5.1.1"/>
<text
value="If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.2"/>
<text
value="Describe how permission to participate in the study will be obtained from the parents or legal guardians:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3"/>
<text value="Assent process of children"/>
<item>
<linkId value="p9.1.7.5.3.1"/>
<text
value="Describe waiting period between informing the prospective participant and obtaining the assent"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.2"/>
<text value="Describe any process to ensure ongoing assent"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.3"/>
<text
value="Describe Research team members involved in the assent process:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.4"/>
<text
value="Describe how long children will have to consider study participation:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.5"/>
<text
value="Describe steps that will be taken to minimize the possibility of coercion or undue influence:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.6"/>
<text
value="Describe steps that will be taken to ensure the participants's understanding:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.7"/>
<text
value="If assent will not be obtained from children, specify why:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.8"/>
<text
value="Will children reach 18 years of age while in the study?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.3.9"/>
<text value="Children reaching 18 years of age while in the study"/>
<item>
<linkId value="p9.1.7.5.1.9.1"/>
<text
value="Describe the plan to obtain written informed consent from the participant at age 18 years:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.1.9.2"/>
<text
value="Describe who will be responsible for managing the plan:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.1.9.3"/>
<text
value="Describe where the consent discussion will take place:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.5.1.9.4"/>
<text
value="Describe what will happen if the participant cannot be located to provide consent at age 18 years:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
</item>
<item>
<linkId value="p9.1.7.6"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.7"/>
<text
value="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 value="p9.1.7.7.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.7.2"/>
<text
value="Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.7.3"/>
<text
value="Describe any additional steps or procedures that will be used when performing informed consent with this population:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.8"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.9"/>
<text
value="Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent"/>
<item>
<linkId value="p9.1.7.9.1"/>
<text
value="Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.2"/>
<text
value="Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.4"/>
<text
value="Describe the process to determine whether or not the individual is capable of consent:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.5"/>
<text
value="Describe who will determine if the participant is able to provide informed consent:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.6"/>
<text
value="Describe how it will be determined whether the participant is able to provide informed consent:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.7"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.8"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.9"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.10"/>
<text value="Process for assent of participants"/>
<item>
<linkId value="p9.1.7.9.10.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.10.2"/>
<text
value="If assent will not be obtained from some or all participants, an explanation of why not:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.10.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.9.11"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.9.12"/>
<text
value="Participants will be withdrawn if they appear to be unduly distressed at any time during the study."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.10"/>
<text value="Can or will prisoners be enrolled?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.11"/>
<text value="Enrollment of prisoners"/>
<item>
<linkId value="p9.1.7.11.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.11.2"/>
<text
value="Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.11.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.11.4"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.11.5"/>
<text
value="A letter of support from the Prison this research will be conducted in has been submitted to the IRB."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.11.6"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.12"/>
<text
value="Can or will students and/or employees be enrolled in this research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.13"/>
<text value="Enrollment of students and/or employees"/>
<item>
<linkId value="p9.1.7.13.1"/>
<text
value="Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.13.2"/>
<text value="Describe how potential coercion will be eliminated"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.13.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.13.4"/>
<text
value="Describe additional safeguards included to protect the rights and welfare of students and employees:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.13.5"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.13.6"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="p9.1.7.14"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.15"/>
<text
value="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 value="p9.1.7.15.1"/>
<text
value="Describe the justification for recruiting and enrolling this population"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.2"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.4"/>
<text
value="Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.5"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.6"/>
<text value="Is the study is greater than minimal risk?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.7"/>
<text value="Greater than minimal risk study"/>
<item>
<linkId value="p9.1.7.15.7.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.7.2"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.7.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.1.7.15.7.4"/>
<text
value="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 value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
</item>
</item>
</item>
<item>
<linkId value="p9.2"/>
<text value="STRATEGIES FOR RECRUITMENT AND RETENTION"/>
<item>
<linkId value="p9.2.1"/>
<text value="Recruitment Methods"/>
<item>
<linkId value="p9.2.1.1"/>
<text
value="Describe when, where, and how potential participants will be recruited"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.2.1.2"/>
<text
value="When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.)."/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.2.1.3"/>
<text
value="Describe source of participants (for example, patient population, local community, etc.):"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.2.1.4"/>
<text
value="Describe methods that will be used to identify potential participants:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p9.2.1.5"/>
<text
value="Describe how the recruitment methods described will be effective in attracting the targeted participant population:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p9.3"/>
<text
value="DURATION OF STUDY PARTICIPATION. (If there are sub-studies, include duration of participation in each sub-study.)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p10"/>
<text value="STUDY INTERVENTION"/>
<item>
<linkId value="p10.1"/>
<text value="Study Agent"/>
<item>
<linkId value="p10.1.1"/>
<text value="Study Agent and Control Description"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.2"/>
<text value="Receipts/Acquisition"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.3"/>
<text
value="Study Agent Accountability/ Return or Destruction of Investigational Product"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.4"/>
<text value="Formulation and appearance of Control Product"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.5"/>
<text value="Formulation and appearance of Test Product"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.6"/>
<text value="Packaging and Labeling"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.7"/>
<text value="Product Storage and Stability"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.8"/>
<text value="Preparation"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.9"/>
<text value="Administration and/or Dosing"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.10"/>
<text value="Route of Administration"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.11"/>
<text value="Starting Dose and Dose Escalation Schedule"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.12"/>
<text value="Dose Adjustments/Modifications/Delays"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.13"/>
<text value="Duration of Therapy"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.14"/>
<text value="Tracking Dose"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.15"/>
<text value="Device Specific Considerations"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.16"/>
<text value="Administration Instructions"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.17"/>
<text value="Dispensing [authority, requirements]"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.1.18"/>
<text value="Supply of Study Drug at the Site"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p10.3"/>
<text value="Study Procedural Intervention(s) Description"/>
<item>
<linkId value="p10.3.1"/>
<text value="Administration of Procedural Intervention"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.3.2"/>
<text
value="Procedures for Training of Clinicians on Procedural Intervention"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.3.3"/>
<text
value="Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p10.4"/>
<text value="Participant Compliance and Monitoring"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p10.5"/>
<text value="Study Intervention/Experimental Manipulation Adherence"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p11"/>
<text
value="STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL"/>
<item>
<linkId value="p11.1"/>
<text value="Discontinuation of Study Intervention"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p11.2"/>
<text value="Participant withdrawal and Termination"/>
<item>
<linkId value="p11.2.1"/>
<text value="Reasons for Withdrawal or Termination"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p11.2.2"/>
<text value="Handling of Participant Withdrawal or Termination"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p11.2.3"/>
<text value="Replacement of participants"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p11.3"/>
<text value="Lost to Follow-Up"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p12"/>
<text value="STUDY PROCEDURES"/>
<item>
<linkId value="p12.1"/>
<text value="Study Procedures/Evaluations"/>
<item>
<linkId value="p12.1.1"/>
<text value="Study Specific Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.1.2"/>
<text value="Standard of Care Study Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p12.2"/>
<text value="Laboratory Procedures/Evaluations"/>
<item>
<linkId value="p12.2.1"/>
<text value="Clinical Laboratory Evaluations"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.2.2"/>
<text value="Research Laboratory Evaluations"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.2.3"/>
<text value="Other Assays or Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.2.4"/>
<text value="Specimen Preparation, Handling, and Storage"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.2.5"/>
<text value="Specimen Shipment"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p12.3"/>
<text value="Data Collection and Follow Up for Withdrawn participants"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.4"/>
<text
value="Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception)."/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.5"/>
<text value="Precautionary Medications, Treatments, and Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.6"/>
<text value="Prohibited Medications, Treatments, and Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.7"/>
<text value="Prophylactic Medications, Treatments, and Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.8"/>
<text value="Rescue Medications, Treatments, and Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.9"/>
<text value="Participant Access to Study Agent at Study Closure"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p12.10"/>
<text value="Concomitant Medications, Treatments , and Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p13"/>
<text value="SCHEDULE OF STUDY PROCEDURES"/>
<item>
<linkId value="p13.1"/>
<text value="Screening"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.2"/>
<text value="Enrollment/Visit 1/Baseline Visit"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.3"/>
<text value="Intermediate Visits"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.4"/>
<text value="Final Study Visit"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.5"/>
<text value="Withdrawal/Early Termination Visit"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.6"/>
<text value="Unscheduled Visit"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.7"/>
<text value="Follow Up Phase of the Study"/>
<item>
<linkId value="p13.7.1"/>
<text value="Visit"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p13.7.2"/>
<text value="End of Study Visit"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p14"/>
<text value="ASSESSMENT OF SAFETY"/>
<item>
<linkId value="p14.1"/>
<text value="Specification of Safety Parameters"/>
<item>
<linkId value="p14.1.1"/>
<text value="Definition of Adverse Events(AE)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.1.2"/>
<text value="Definition of Serious Adverse Events (SAE)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.1.3"/>
<text value="Definition of Unanticipated Problems"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p14.2"/>
<text value="Classification of an Adverse Event"/>
<item>
<linkId value="p14.2.1"/>
<text value="Severity of an Event"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.2.2"/>
<text
value="Relationship to Study Intervention/Experimental Manipulation"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.2.3"/>
<text value="Expectedness"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p14.3"/>
<text
value="Time Period and Frequencey for Event Assessment and Follow-Up"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4"/>
<text value="Reporting Procedures"/>
<item>
<linkId value="p14.4.1"/>
<text value="Notifying the IRB"/>
<item>
<linkId value="p14.4.1.1"/>
<text value="Adverse Event Reporting"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.1.2"/>
<text value="Serious Adverse Event Reporting"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.1.3"/>
<text value="Unanticipated Problem Reporting"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.1.4"/>
<text value="Reporting of Pregnancy"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p14.4.2"/>
<text value="Notifyiing the Study Sponsor"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.3"/>
<text value="Notifying the FDA"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.4"/>
<text value="Notifying Participating Investigators"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.5"/>
<text value="Reporting Events to Participants"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.4.6"/>
<text value="Events of Special Interest"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p14.5"/>
<text value="Follow Up Report"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p14.6"/>
<text value="Study Halting/Stopping Rules"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p15"/>
<text value="STATISTICAL CONSIDERATIONS"/>
<item>
<linkId value="p15.1"/>
<text value="Statistical and Analytical Plans(SAP)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.2"/>
<text value="Statistical Hypotheses"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.3"/>
<text value="Analysis Datasets"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.4"/>
<text value="Populations for Analysis"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.5"/>
<text value="Sample Size Determination"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6"/>
<text value="Description of Statistical Methods"/>
<item>
<linkId value="p15.6.1"/>
<text value="General Approach"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.2"/>
<text value="Analysis of Primary Efficacy Endpoints(s)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.3"/>
<text value="Analysis of Secondary Endpoint(s)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.4"/>
<text value="Safety Analyses"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.5"/>
<text value="Adherence and Retention Analyses"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.6"/>
<text value="Baseline Descriptive Statistics"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.7"/>
<text value="Planned Interim Analyses"/>
<item>
<linkId value="p15.6.7.1"/>
<text value="Safety Review"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.7.2"/>
<text value="Efficacy Review"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p15.6.8"/>
<text value="Additional Sub-Group Analyses"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.9"/>
<text value="Multiple Comparison/Multiplicity"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.10"/>
<text value="Tabulation of Individual Response Data"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.11"/>
<text value="Exploratory Analyses"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.6.12"/>
<text value="Pharmacokinetic Analysis (if applicable)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p15.7"/>
<text value="Sample Size"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.8"/>
<text value="Measures to Minimize Bias"/>
<item>
<linkId value="p15.8.1"/>
<text value="Enrollment/Randomization/Masking Procedures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.8.2"/>
<text value="Evaluation of Success of Blinding"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p15.8.3"/>
<text value="Breaking the Study Blind/Participant Code"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p16"/>
<text value="SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS"/>
<item>
<linkId value="p16.1"/>
<text value="Regulatory, Ethical and Study Oversight Considerations"/>
<item>
<linkId value="p16.1.1"/>
<text value="Protocol Amendments"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.2"/>
<text value="Ethical Standard"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.3"/>
<text value="Institutional Review Board"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4"/>
<text value="Informed Consent Process"/>
<item>
<linkId value="p16.1.4.1"/>
<text
value="Consent/Assent and Other Informational Documents Provided to Participants"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4.2"/>
<text value="Consent Procedures and Documentation"/>
<item>
<linkId value="p16.1.4.2.1"/>
<text
value="Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4.2.2"/>
<text
value="Describe the parental permission process and the child assent process. (If study involves children)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4.2.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4.2.4"/>
<text value="Methods of Informed Consent for non-English Speakers"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4.2.5"/>
<text value="Waiver or Alteration of Consent Process"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.4.2.6"/>
<text value="HIPAA Authorization"/>
<item>
<linkId value="p16.1.4.2.7.1"/>
<text
value="Participant's Capacity to Give Legally Effective Consent"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p16.1.4.3"/>
<text value="Indicate where the consent process will take place."/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p16.1.5"/>
<text value="Participant data and Confidentialty"/>
<item>
<linkId value="p16.1.5.1"/>
<text value="Research Use of Stored Human Samples, Specimens, or Data"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.5.2"/>
<text value="Confidentiality of Research Biospeciemen/Data"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.5.3"/>
<text value="Certificate of Confidentiality (if applicable)"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.5.4"/>
<text value="Provisions to Protect the Privacy of Participants:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p16.1.6"/>
<text value="Future Use of Stored Human Specimens and Data"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.7"/>
<text value="Study Discontinuation and Closure"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8"/>
<text value="Key Roles and Expertise of Study Team"/>
<item>
<linkId value="p16.1.8.1"/>
<text value="First Name"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8.2"/>
<text value="Last Name"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8.3"/>
<text value="Position/Title"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8.4"/>
<text value="Responsibilities"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p16.1.8"/>
<text value="Key Roles and Expertise of Study Team"/>
<item>
<linkId value="p16.1.8.1"/>
<text value="First Name"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8.2"/>
<text value="Last Name"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8.3"/>
<text value="Position/Title"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.8.4"/>
<text value="Responsibilities"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p16.1.9"/>
<text value="Safety Oversight"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.10"/>
<text value="Clinical Monitoring"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.11"/>
<text value="Quality Assurance and Quality Control"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.12"/>
<text value="Data Handling and Record Keeping"/>
<item>
<linkId value="p16.1.12.1"/>
<text value="Data Quality Control and Reporting"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.12.2"/>
<text value="Data Collection and Management Responsibilities"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.12.3"/>
<text value="Data Archival"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.12.4"/>
<text value="Study Records Retention"/>
<item>
<linkId value="p16.1.12.4.1"/>
<text value="Photographs, Audio/Video Recordings Retention"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.12.4.2"/>
<text value="Data and/or Biological Specimens Access"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.12.4.3"/>
<text value="Data and/or Biological Specimens Retention/Banking"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p16.1.13"/>
<text value="Protocol Deviations"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.14"/>
<text value="Publication and Data Sharing Policy"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.15"/>
<text value="Conflict of Interest Policy"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.16"/>
<text value="Source Documents and Access to Source Data/Documents"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.1.17"/>
<text value="Collections of Photographs, or Audio/Video Recording"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p16.2"/>
<text value="Prior Approvals/Attachments Requiring Signatures"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.3"/>
<text value="Additional Considerations"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.4"/>
<text value="Abbreviations and Special Terms"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p16.5"/>
<text value="Attachments"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p17"/>
<text value="STUDY ADMINISTRATION"/>
<item>
<linkId value="p17.1"/>
<text value="Setting"/>
<item>
<linkId value="p17.1.1"/>
<text
value="Describe the sites / locations where your research team will conduct the research:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p17.2"/>
<text value="Registration"/>
<item>
<linkId value="p17.2.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p17.3"/>
<text value="Resources Available"/>
<item>
<linkId value="p17.3.1"/>
<text value="Describe the roles/tasks of each research team member"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.3.2"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.3.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.3.4"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.3.5"/>
<text
value="Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="p17.4"/>
<text value="IRB Review"/>
<item>
<linkId value="p17.4.1"/>
<text
value="An appropriate IRB , registered with the OHRP ,review and approve this study."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p17.4.2"/>
<text
value="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>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="p17.5"/>
<text value="Community-Based Participatory Research/Field Research"/>
<item>
<linkId value="p17.5.1"/>
<text
value="Can or will this study involve community-based participatory research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="p17.5.2"/>
<text value="Community-based participatory research"/>
<item>
<linkId value="p17.5.2.1"/>
<text
value="Describe the communities that will be involved in this research:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.5.2.2"/>
<text
value="Describe the composition and involvement of any community advisory board:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.5.2.3"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.5.2.4"/>
<text
value="Describe the plans on dissemination and publication of study results which are in agreement with the community:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="p17.6"/>
<text value="Multi Site Research"/>
<item>
<linkId value="p17.6.1"/>
<text
value="Describe the plan for tracking IRB approval of documents and consent forms for each site:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.2"/>
<text
value="Name of the sponsor and Contract Research Organization (CRO):"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.3"/>
<text
value="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>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.4"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.5"/>
<text
value="Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.6"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.7"/>
<text
value="Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations:"/>
<item>
<linkId value="p17.6.7.1"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.7.2"/>
<text
value="Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p17.6.8"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.9"/>
<text
value="Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable):"/>
<item>
<linkId value="p17.6.9.1"/>
<text
value="Describe how they will be provided to each enrolling site:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.9.2"/>
<text value="Describe how dispensing will be monitored:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.9.3"/>
<text
value="Describe what investigational product accountability procedures will be implemented:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p17.6.10"/>
<text
value="Describe the procedures for study closures and early site termination:"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p17.6.11"/>
<text
value="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 value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p17.7"/>
<text value="Key Roles and Study Governance"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p18"/>
<text value="STUDY FINANCES"/>
<item>
<linkId value="p18.1"/>
<text value="Funding Source"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p18.2"/>
<text value="Costs to the participant"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p18.3"/>
<text value="Participant Reimbursements or Payments"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="p18.4"/>
<text value="Compensation for Research-Related Injury"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="p19"/>
<text value="REFERENCES"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="p"/>
</answer>
</item>
</item>
</QuestionnaireResponse>
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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