Generated Narrative

questionnaire: https://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire

status: completed

authored: Jul 23, 2021 2:13:33 AM

item

linkId: p1

text: Research Study

item

linkId: p1.1

text: Study Type

item

linkId: p1.2

text: Intervention

item

linkId: p1.3

text: Does this protocol require an FDA exemption?

item

linkId: p1.4

text: Type of exemption

item

linkId: p1.5

text: Study Title

item

linkId: p1.6

text: Study Title (Short)

item

linkId: p1.61

text: Principal Investigator

item

linkId: p1.7

text: Additional Investigator

item

linkId: p1.8

text: Additional Investigator

item

linkId: p1.9

text: IRB Protocol Number

item

linkId: p1.10

text: Sponsor Protocol Number

item

linkId: p1.11

text: ClinicalTrials.Gov Identifier

item

linkId: p1.14

text: IND Number

item

linkId: p1.16

text: Study Product Name

item

linkId: p1.17

text: Study Product Provider

item

linkId: p1.18

text: Funding Organization

item

linkId: p1.19

text: Sponsor

item

linkId: p1.20

text: Medical Monitor

item

linkId: p1.21

text: Confidentialty Statement

item

linkId: p1.22

text: Investigator's Signature

item

linkId: p1.23

text: Protocol Version Number

item

linkId: p1.24

text: Protocol Version Date

item

linkId: p2.4

text: Statement of Compliance

Answers

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Value[x]

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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.

item

linkId: p3

text: Protocol Summary

item

linkId: p3.1

text: Synopsis

item

linkId: p3.2

text: Schema

item

linkId: p3.3

text: Schedule of Activities

item

linkId: p4

text: INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONAL

item

linkId: p4.1

text: Background

item

linkId: p4.2

text: Study Rationale

item

linkId: p4.3

text: Risk/Benefit Assessment

item

linkId: p5

text: STUDY PURPOSE, OBJECTIVES OR SPECIFIC AIMS

item

linkId: p5.1

text: Hypothesis

item

linkId: p5.2

text: Primary Objectives

item

linkId: p5.3

text: Secondary Objectives

item

linkId: p5.4

text: Tertiary/Exploratory Objectives

item

linkId: p6

text: STUDY ENDPOINTS

item

linkId: p6.1

text: Primary Endpoints

item

linkId: p6.2

text: Secondary Endpoints

item

linkId: p6.3

text: Tertiary Endpoints

item

linkId: p6.4

text: Primary Safety endpoints

item

linkId: p6.5

text: Secondary Safety endpoints

item

linkId: p6.6

text: Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.

item

linkId: p7

text: STUDY DESIGN

item

linkId: p7.1

text: Overall Design

item

linkId: p7.2

text: Scientific Rationale for Study Design

item

linkId: p7.3

text: Justification for Dose

item

linkId: p7.4

text: Justification for Intervention

item

linkId: p7.5

text: End of Study Definition

item

linkId: p7.6

text: Screening Activities

item

linkId: p7.7

text: Study Intervention Activities

item

linkId: p7.8

text: Follow Up Activities

item

linkId: p7.9

text: Allocation to Interventional Group

item

linkId: p7.10

text: Study/Data Collection Instruments

item

linkId: p7.11

text: Research Setting

item

linkId: p8

text: STUDY POPULATION

item

linkId: p8.1

text: Participant Selection

item

linkId: p9

text: STUDY ENROLLMENT AND WITHDRAWAL

item

linkId: p9.1

text: Eligibility Criteria

item

linkId: p9.2

text: STRATEGIES FOR RECRUITMENT AND RETENTION

item

linkId: p9.3

text: DURATION OF STUDY PARTICIPATION. (If there are sub-studies, include duration of participation in each sub-study.)

item

linkId: p10

text: STUDY INTERVENTION

item

linkId: p10.1

text: Study Agent

item

linkId: p10.3

text: Study Procedural Intervention(s) Description

item

linkId: p10.4

text: Participant Compliance and Monitoring

item

linkId: p10.5

text: Study Intervention/Experimental Manipulation Adherence

item

linkId: p11

text: STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL

item

linkId: p11.1

text: Discontinuation of Study Intervention

item

linkId: p11.2

text: Participant withdrawal and Termination

item

linkId: p11.3

text: Lost to Follow-Up

item

linkId: p12

text: STUDY PROCEDURES

item

linkId: p12.1

text: Study Procedures/Evaluations

item

linkId: p12.2

text: Laboratory Procedures/Evaluations

item

linkId: p12.3

text: Data Collection and Follow Up for Withdrawn participants

item

linkId: p12.4

text: Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).

item

linkId: p12.5

text: Precautionary Medications, Treatments, and Procedures

item

linkId: p12.6

text: Prohibited Medications, Treatments, and Procedures

item

linkId: p12.7

text: Prophylactic Medications, Treatments, and Procedures

item

linkId: p12.8

text: Rescue Medications, Treatments, and Procedures

item

linkId: p12.9

text: Participant Access to Study Agent at Study Closure

item

linkId: p12.10

text: Concomitant Medications, Treatments , and Procedures

item

linkId: p13

text: SCHEDULE OF STUDY PROCEDURES

item

linkId: p13.1

text: Screening

item

linkId: p13.2

text: Enrollment/Visit 1/Baseline Visit

item

linkId: p13.3

text: Intermediate Visits

item

linkId: p13.4

text: Final Study Visit

item

linkId: p13.5

text: Withdrawal/Early Termination Visit

item

linkId: p13.6

text: Unscheduled Visit

item

linkId: p13.7

text: Follow Up Phase of the Study

item

linkId: p14

text: ASSESSMENT OF SAFETY

item

linkId: p14.1

text: Specification of Safety Parameters

item

linkId: p14.2

text: Classification of an Adverse Event

item

linkId: p14.3

text: Time Period and Frequencey for Event Assessment and Follow-Up

item

linkId: p14.4

text: Reporting Procedures

item

linkId: p14.5

text: Follow Up Report

item

linkId: p14.6

text: Study Halting/Stopping Rules

item

linkId: p15

text: STATISTICAL CONSIDERATIONS

item

linkId: p15.1

text: Statistical and Analytical Plans(SAP)

item

linkId: p15.2

text: Statistical Hypotheses

item

linkId: p15.3

text: Analysis Datasets

item

linkId: p15.4

text: Populations for Analysis

item

linkId: p15.5

text: Sample Size Determination

item

linkId: p15.6

text: Description of Statistical Methods

item

linkId: p15.7

text: Sample Size

item

linkId: p15.8

text: Measures to Minimize Bias

item

linkId: p16

text: SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS

item

linkId: p16.1

text: Regulatory, Ethical and Study Oversight Considerations

item

linkId: p16.2

text: Prior Approvals/Attachments Requiring Signatures

item

linkId: p16.3

text: Additional Considerations

item

linkId: p16.4

text: Abbreviations and Special Terms

item

linkId: p16.5

text: Attachments

item

linkId: p17

text: STUDY ADMINISTRATION

item

linkId: p17.1

text: Setting

item

linkId: p17.2

text: Registration

item

linkId: p17.3

text: Resources Available

item

linkId: p17.4

text: IRB Review

item

linkId: p17.5

text: Community-Based Participatory Research/Field Research

item

linkId: p17.6

text: Multi Site Research

item

linkId: p17.7

text: Key Roles and Study Governance

item

linkId: p18

text: STUDY FINANCES

item

linkId: p18.1

text: Funding Source

item

linkId: p18.2

text: Costs to the participant

item

linkId: p18.3

text: Participant Reimbursements or Payments

item

linkId: p18.4

text: Compensation for Research-Related Injury

item

linkId: p19

text: REFERENCES

Answers

-	Value[x]
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item

linkId: ADMIN00

text: Administrative Use Only

item

linkId: ADMIN01

text: Link ID prefix