protocol-populate-exampleQR
type: QuestionnaireResponse
node role: treeRoot
id:
  v: protocol-populate-exampleQR
meta:
  version id:
    v: 1
  last updated:
    v: 2022-02-27T23:07:35.159+00:00
text:
  status:
    v: generated
  div: LinkId Text Definition Answer<img src="[binary]" alt="doco" style="background-color: inherit"/> protocol-populate-exampleQR QuestionnaireResponse p1 Research Study p1.1 Study Type Temporary Codes INT: Interventional p1.2 Intervention Temporary Codes DBV: Drug/Biologic/Vaccine p1.3 Does this protocol require a FDA exemption? expandedYes-NoIndicator Y: Yes p1.30 Is an IND or IDE being used in this study? expandedYes-NoIndicator Y: Yes p1.4 Type of exemption Temporary Codes IND: IND p1.5 Study Title A clinical study of the efficacy of Drug A for arthritis p1.6 Study Title (Short) Study of Drug A for arthritis p1.61 Lead Principal Investigator p1.61.1 First Name Jane p1.61.2 Last Name Doe p1.61.8 Degree(s) MD p1.61.3 Department Name Orthopedics p1.61.4 Address p1.61.4.1 Street Address 105 Sample University Ct. p1.61.4.2 City Sample City p1.61.4.3 State NC p1.61.4.4 Zip Code 27612 p1.61.4.5 Country United States p1.61.5 Phone 567-123-1234 p1.61.6 Email drjanedoe@sampleuniversity.edu p1.7 Additional Investigator expandedYes-NoIndicator Y: Yes p1.8 Additional Investigator p1.8.1 Additional Investigator Role Temporary Codes PD: Program Director p1.8.2 First Name [answer] p1.8.3 Last Name [answer] p1.8.8 Suffix [answer] p1.8.9 Degree(s) [answer] p1.8.4 Department Name [answer] p1.8.5 Address p1.8.5.1 Street Address [answer] p1.8.5.2 City [answer] p1.8.5.3 State [answer] p1.8.5.4 Zip Code 12345 p1.8.5.5 Country [answer] p1.8.6 Phone 111-111-11111 p1.8.7 Email [answer] p1.9 IRB Protocol Number PRO098765 p1.10 Sponsor Name(s) and Protocol Number ExternalDataFor_p1.10.1.1 External Data For linkId p1.10.1.1 p1.10.1 Sponsor p1.10.1.1 Sponsor Name [not stated] : National Government Funder p1.10.1.2 Sponsor Protocol Number Gov-123456 p1.10.1 Sponsor p1.10.1.1 Sponsor Name [not stated] : Organization of Arthritis Patients Foundation p1.11 ClinicalTrials.Gov Identifier 12345 p1.12 Grant Title A ClinicalStudy of Drug A for arthritis12345 p1.13 NIH Grant Number 12345 p1.14 IND Number 43…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-researchStudy
  value: Reference
    link: http://hl7.org/fhir/us/sirb/ResearchStudy/ResearchStudyExample-sIRB
    reference:
      v: ResearchStudy/ResearchStudyExample-sIRB
    display:
      v: ResearchStudyExample-sIRB
questionnaire:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate
  link: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate
status:
  v: completed
authored:
  v: 2022-02-27T23:07:34.088Z
item:
  link id:
    v: p1
  text:
    v: Research Study
  item:
    link id:
      v: p1.1
    text:
      v: Study Type
    answer:
      value: Coding
  item:
    link id:
      v: p1.2
    text:
      v: Intervention
    answer:
      value: Coding
  item:
    link id:
      v: p1.3
    text:
      v: Does this protocol require a FDA exemption?
    answer:
      value: Coding
  item:
    link id:
      v: p1.30
    text:
      v: Is an IND or IDE being used in this study?
    answer:
      value: Coding
  item:
    link id:
      v: p1.4
    text:
      v: Type of exemption
    answer:
      value: Coding
  item:
    link id:
      v: p1.5
    text:
      v: Study Title
    answer:
      value:
        v: A clinical study of the efficacy of Drug A for arthritis
  item:
    link id:
      v: p1.6
    text:
      v: Study Title (Short)
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: p1.61
    text:
      v: Lead Principal Investigator
    item:
      link id:
        v: p1.61.1
      text:
        v: First Name
    item:
      link id:
        v: p1.61.2
      text:
        v: Last Name
    item:
      link id:
        v: p1.61.8
      text:
        v: Degree(s)
    item:
      link id:
        v: p1.61.3
      text:
        v: Department Name
    item:
      link id:
        v: p1.61.4
      text:
        v: Address
    item:
      link id:
        v: p1.61.5
      text:
        v: Phone
    item:
      link id:
        v: p1.61.6
      text:
        v: Email
  item:
    link id:
      v: p1.7
    text:
      v: Additional Investigator
    answer:
      value: Coding
  item:
    link id:
      v: p1.8
    text:
      v: Additional Investigator
    item:
      link id:
        v: p1.8.1
      text:
        v: Additional Investigator Role
      answer:
        value: Coding
    item:
      link id:
        v: p1.8.2
      text:
        v: First Name
    item:
      link id:
        v: p1.8.3
      text:
        v: Last Name
    item:
      link id:
        v: p1.8.8
      text:
        v: Suffix
    item:
      link id:
        v: p1.8.9
      text:
        v: Degree(s)
    item:
      link id:
        v: p1.8.4
      text:
        v: Department Name
    item:
      link id:
        v: p1.8.5
      text:
        v: Address
    item:
      link id:
        v: p1.8.6
      text:
        v: Phone
    item:
      link id:
        v: p1.8.7
      text:
        v: Email
  item:
    link id:
      v: p1.9
    text:
      v: IRB Protocol Number
    answer:
      value:
        v: PRO098765
  item:
    link id:
      v: p1.10
    text:
      v: Sponsor Name(s) and Protocol Number
    item:
      link id:
        v: ExternalDataFor_p1.10.1.1
      text:
        v: External Data For linkId p1.10.1.1

v: INT

v: Interventional

v: DBV

v: Drug/Biologic/Vaccine

v: Y

v: Yes

v: Y

v: Yes

v: IND

v: IND

v: Jane

v: Doe

v: MD

v: Orthopedics

v: p1.61.4.1

v: Street Address

value:
  v: 105 Sample University Ct.

v: p1.61.4.2

v: City

value:
  v: Sample City

v: p1.61.4.3

v: State

value:
  v: NC

v: p1.61.4.4

v: Zip Code

value:
  v: 27612

v: p1.61.4.5

v: Country

value:
  v: United States

v: 567-123-1234

v: Y

v: Yes

Coding
system:
  v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
code:
  v: PD
display:
  v: Program Director

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: p1.8.5.1

v: Street Address

value:
  v: [answer]

v: p1.8.5.2

v: City

value:
  v: [answer]

v: p1.8.5.3

v: State

value:
  v: [answer]

v: p1.8.5.4

v: Zip Code

value:
  v: 12345

v: p1.8.5.5

v: Country

value:
  v: [answer]

v: 111-111-11111

v: [answer]

v: National Government Funder

v: Organization of Arthritis Patients Foundation

link id:
  v: p1.10.1
text:
  v: Sponsor
item:
  link id:
    v: p1.10.1.1
  text:
    v: Sponsor Name
  answer:
    value: Coding
      display:
        v: National Government Funder
item:
  link id:
    v: p1.10.1.2
  text:
    v: Sponsor Protocol Number
  answer:
    value:
      v: Gov-123456

link id:
  v: p1.10.1
text:
  v: Sponsor
item:
  link id:
    v: p1.10.1.1
  text:
    v: Sponsor Name
  answer:
    value: Coding
      display:
        v: Organization of Arthritis Patients Foundation

link id:
  v: p1.11
text:
  v: ClinicalTrials.Gov Identifier
answer:
  value:
    v: 12345

link id:
  v: p1.12
text:
  v: Grant Title
answer:
  value:
    v: A ClinicalStudy of Drug A for arthritis12345

link id:
  v: p1.13
text:
  v: NIH Grant Number
answer:
  value:
    v: 12345

link id:
  v: p1.14
text:
  v: IND Number
answer:
  value:
    v: 432fdw512432fqsdf

link id:
  v: p1.16
text:
  v: Study Product Name
answer:
  value:
    v: Drug A

link id:
  v: p1.17
text:
  v: Study Product Provider
answer:
  value:
    v: [answer]

link id:
  v: p1.18
text:
  v: Funding Organization(s), Address and Contact Information
item:
  link id:
    v: ExternalDataFor_p1.18.1.1
  text:
    v: External Data For linkId p1.18.1.1
  answer:
    value:
      v: National Government Funder
  answer:
    value:
      v: Organization of Arthritis Patients Foundation
item:
  link id:
    v: p1.18.1
  text:
    v: Funding Organization
  item:
    link id:
      v: p1.18.1.1
    text:
      v: Name
    answer:
      value: Coding
  item:
    link id:
      v: p1.18.1.2
    text:
      v: Address
    item:
      link id:
        v: p1.18.1.2.1
      text:
        v: Street Address
    item:
      link id:
        v: p1.18.1.2.2
      text:
        v: City
    item:
      link id:
        v: p1.18.1.2.3
      text:
        v: State
    item:
      link id:
        v: p1.18.1.2.4
      text:
        v: Zip Code
    item:
      link id:
        v: p1.18.1.2.5
      text:
        v: Country
  item:
    link id:
      v: p1.18.1.5
    text:
      v: Phone
    answer:
      value:
        v: 800-123-1234
  item:
    link id:
      v: p1.18.1.4
    text:
      v: Email
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p1.18.1
  text:
    v: Funding Organization
  item:
    link id:
      v: p1.18.1.1
    text:
      v: Name
    answer:
      value: Coding
  item:
    link id:
      v: p1.18.1.2
    text:
      v: Address
    item:
      link id:
        v: p1.18.1.2.1
      text:
        v: Street Address
    item:
      link id:
        v: p1.18.1.2.2
      text:
        v: City
    item:
      link id:
        v: p1.18.1.2.3
      text:
        v: State
    item:
      link id:
        v: p1.18.1.2.4
      text:
        v: Zip Code
    item:
      link id:
        v: p1.18.1.2.5
      text:
        v: Country
  item:
    link id:
      v: p1.18.1.5
    text:
      v: Phone
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p1.18.1.4
    text:
      v: Email
    answer:
      value:
        v: [answer]

v: National Government Funder

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: Organization of Arthritis Patients Foundation

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p1.19
text:
  v: Sponsor(s), Address and Contact Information
item:
  link id:
    v: ExternalDataFor_p1.19.1.1
  text:
    v: External Data For linkId p1.19.1.1
  answer:
    value:
      v: National Government Funder
  answer:
    value:
      v: Organization of Arthritis Patients Foundation
item:
  link id:
    v: p1.19.1
  text:
    v: Sponsor
  item:
    link id:
      v: p1.19.1.1
    text:
      v: Name
    answer:
      value: Coding
  item:
    link id:
      v: p1.19.1.3
    text:
      v: Address
    item:
      link id:
        v: p1.19.1.3.1
      text:
        v: Street Address
    item:
      link id:
        v: p1.19.1.3.2
      text:
        v: City
    item:
      link id:
        v: p1.19.1.3.3
      text:
        v: State
    item:
      link id:
        v: p1.19.1.3.4
      text:
        v: Zip Code
    item:
      link id:
        v: p1.19.1.3.5
      text:
        v: Country
  item:
    link id:
      v: p1.19.1.4
    text:
      v: Email
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p1.19.1.5
    text:
      v: Phone
    answer:
      value:
        v: 800-123-1234
item:
  link id:
    v: p1.19.1
  text:
    v: Sponsor
  item:
    link id:
      v: p1.19.1.1
    text:
      v: Name
    answer:
      value: Coding
  item:
    link id:
      v: p1.19.1.3
    text:
      v: Address
    item:
      link id:
        v: p1.19.1.3.1
      text:
        v: Street Address
    item:
      link id:
        v: p1.19.1.3.2
      text:
        v: City
    item:
      link id:
        v: p1.19.1.3.3
      text:
        v: State
    item:
      link id:
        v: p1.19.1.3.4
      text:
        v: Zip Code
    item:
      link id:
        v: p1.19.1.3.5
      text:
        v: Country
  item:
    link id:
      v: p1.19.1.4
    text:
      v: Email
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p1.19.1.5
    text:
      v: Phone
    answer:
      value:
        v: [answer]

v: National Government Funder

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: Organization of Arthritis Patients Foundation

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p1.20
text:
  v: Medical Monitor
item:
  link id:
    v: p1.20.1
  text:
    v: First Name
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p1.20.2
  text:
    v: Last Name
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p1.20.6
  text:
    v: Suffix
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p1.20.7
  text:
    v: Degree(s)
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p1.20.3
  text:
    v: Phone
  answer:
    value:
      v: 202-222-2222
item:
  link id:
    v: p1.20.4
  text:
    v: Email
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p1.20.5
  text:
    v: Address
  item:
    link id:
      v: p1.20.5.1
    text:
      v: Street Address
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p1.20.5.2
    text:
      v: City
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p1.20.5.3
    text:
      v: State
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p1.20.5.4
    text:
      v: Zip Code
    answer:
      value:
        v: 12345
  item:
    link id:
      v: p1.20.5.5
    text:
      v: Country
    answer:
      value:
        v: [answer]

link id:
  v: p1.21
text:
  v: Confidentialty Statement
answer:
  value:
    v: [answer]

link id:
  v: p1.23
text:
  v: Protocol Version Number
answer:
  value:
    v: 12345

link id:
  v: p1.24
text:
  v: Protocol Version Date
answer:
  value:
    v: 2022-02-22

link id:
  v: p2
text:
  v: Protocol Amendment Summary of Changes Table
item:
  link id:
    v: p2.1
  text:
    v: Affected Section(s)
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p2.2
  text:
    v: Summary of Revisions Made
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p2.3
  text:
    v: Rationale
  answer:
    value:
      v: [answer]

link id:
  v: p2
text:
  v: Protocol Amendment Summary of Changes Table
item:
  link id:
    v: p2.1
  text:
    v: Affected Section(s)
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p2.2
  text:
    v: Summary of Revisions Made
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p2.3
  text:
    v: Rationale
  answer:
    value:
      v: [answer]

link id:
  v: p2.4
text:
  v: Statement of Compliance
answer:
  value:
    v: [Choose Sample Text] (1) [The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: United 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 Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form 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.] OR (2) [The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training. T…

link id:
  v: p3
text:
  v: Protocol Summary
item:
  link id:
    v: p3.1
  text:
    v: Synopsis
  item:
    link id:
      v: p3.1.1
    text:
      v: Title (Full)
    answer:
      value:
        v: A clinical study of the efficacy of Drug A for arthritis
  item:
    link id:
      v: p3.1.2
    text:
      v: Title (Short)
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: p3.1.3
    text:
      v: Study Description
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.4
    text:
      v: Objectives
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.5
    text:
      v: End Points
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.6
    text:
      v: Accrual Ceiling/Number of Participants (projected-for all sites)
    answer:
      value:
        v: 200
  item:
    link id:
      v: p3.1.7
    text:
      v: Study Population
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.8
    text:
      v: Phase
    answer:
      value: Coding
  item:
    link id:
      v: p3.1.9
    text:
      v: Description of Sites/Facilities Enrolling Participants
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.10
    text:
      v: Description of Study Intervention ( Agent/Procedure)/Investigational Product
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.11
    text:
      v: Study Duration
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.12
    text:
      v: Participant Duration
    answer:
      value:
        v: 3 months
  item:
    link id:
      v: p3.1.13
    text:
      v: Methodology
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.14
    text:
      v: Duration of Investigational Product Administration
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.15
    text:
      v: Key Procedures
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.16
    text:
      v: Main Inclusion/Exclusion Criteria
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.17
    text:
      v: Reference Therapy
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.1.18
    text:
      v: Statistical Analysis
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p3.2
  text:
    v: Schema
  item:
    link id:
      v: p3.2.1
    text:
      v: Attach schema here
    answer:
      value: Attachment
item:
  link id:
    v: p3.3
  text:
    v: Schedule of Activities
  item:
    link id:
      v: p3.3.1
    text:
      v: Schedule of Activities
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p3.3.3
    text:
      v: Schedule of Activities Attachment
    item:
      link id:
        v: p3.3.3.1
      text:
        v: Describe the file that is being attached (optional)
    item:
      link id:
        v: p3.3.3.2
      text:
        v: Attachment
      answer:
        value: Attachment

v: phase-2

v: Phase 2

v: application/vnd.openxmlformats-officedocument.wordprocessingml.document

v: Example attachment.docx

v: 2022-02-27T22:24:16.963Z

v: [answer]

Attachment
content type:
  v: application/vnd.openxmlformats-officedocument.wordprocessingml.document
title:
  v: Example attachment.docx
creation:
  v: 2022-02-27T22:24:16.963Z

link id:
  v: p4
text:
  v: Introduction, Background Information and Scientific Rational
item:
  link id:
    v: p4.1
  text:
    v: Background
  item:
    link id:
      v: p4.1.1
    text:
      v: Describe the relevant literature and the specific gaps in current knowledge that this study intends to address
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p4.1.2
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p4.1.3
    text:
      v: Describe the relevance and usefulness of the objectives
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p4.1.4
    text:
      v: Is this the first time the study drug, device, or intervention/procedure will be used in humans.
    answer:
      value: Coding
  item:
    link id:
      v: p4.1.6
    text:
      v: Investigational Product
    item:
      link id:
        v: p4.1.6.1
      text:
        v: Name and Description
    item:
      link id:
        v: p4.1.6.2
      text:
        v: Preclinical Data
    item:
      link id:
        v: p4.1.6.3
      text:
        v: Clinical Data to Date
  item:
    link id:
      v: p4.1.7
    text:
      v: Is there an active control group?
    answer:
      value: Coding
  item:
    link id:
      v: p4.1.8
    text:
      v: Active Control Group
    item:
      link id:
        v: p4.1.8.1
      text:
        v: 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
    item:
      link id:
        v: p4.1.8.2
      text:
        v: 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:
        value: Coding
    item:
      link id:
        v: p4.1.8.3
      text:
        v: Is the active control an established effective intervention?
      answer:
        value: Coding
item:
  link id:
    v: p4.2
  text:
    v: Study Rationale
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p4.3
  text:
    v: Risk/Benefit Assessment
  item:
    link id:
      v: p4.3.1
    text:
      v: Potential Risks
    item:
      link id:
        v: p4.3.1.1
      text:
        v: 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
    item:
      link id:
        v: p4.3.1.2
      text:
        v: State which study interventions may have unknown risks
    item:
      link id:
        v: p4.3.1.3
      text:
        v: 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
    item:
      link id:
        v: p4.3.1.4
      text:
        v: Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community
    item:
      link id:
        v: p4.3.1.5
      text:
        v: 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:
        value: Coding
    item:
      link id:
        v: p4.3.1.6
      text:
        v: 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:
      link id:
        v: p4.3.1.7
      text:
        v: Other risks
  item:
    link id:
      v: p4.3.2
    text:
      v: Potential Benefits
    item:
      link id:
        v: p4.3.2.1
      text:
        v: 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
    item:
      link id:
        v: p4.3.2.2
      text:
        v: Describe any benefit to the population from which the participant is drawn
    item:
      link id:
        v: p4.3.2.3
      text:
        v: Describe any benefit to science, society, and humanity in general
    item:
      link id:
        v: p4.3.2.4
      text:
        v: Other benefits
  item:
    link id:
      v: p4.3.3
    text:
      v: Alternatives to Study Participation
    item:
      link id:
        v: p4.3.3.1
      text:
        v: Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.)
    item:
      link id:
        v: p4.3.3.2
      text:
        v: Describe the standard clinical care that may be an alternative
    item:
      link id:
        v: p4.3.3.3
      text:
        v: Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting
    item:
      link id:
        v: p4.3.3.4
      text:
        v: Other alternatives to study participation

v: Y

v: Yes

v: [answer]

v: [answer]

v: p4.1.6.3.1

v: Human Pharmacokinetics

value:
  v: [answer]

v: p4.1.6.3.2

v: Clinical Studies in adults

value:
  v: [answer]

v: Y

v: Yes

v: [answer]

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

v: [answer]

v: [answer]

v: [answer]

v: [answer]

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

v: p4.3.1.6.1

v: Describe these risks

value:
  v: [answer]

v: p4.3.1.6.2

v: Describe the procedures that will be put in place to minimize these risks

value:
  v: [answer]

v: p4.3.1.6.3

v: Describe how these procedures are adequate for the location where study procedures will be performed

value:
  v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p5
text:
  v: Study Purpose, Objectives or Specific Aims
item:
  link id:
    v: p5.1
  text:
    v: Hypothesis
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p5.2
  text:
    v: Primary Objectives
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p5.3
  text:
    v: Secondary Objectives
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p5.4
  text:
    v: Tertiary/Exploratory Objectives
  answer:
    value:
      v: [answer]

link id:
  v: p6
text:
  v: Study Endpoints
item:
  link id:
    v: p6.1
  text:
    v: Primary Endpoints
  answer:
    value:
      v: [answer]
    item:
      link id:
        v: p6.1.1
      text:
        v: Justification for Endpoints
item:
  link id:
    v: p6.2
  text:
    v: Secondary Endpoints
  answer:
    value:
      v: [answer]
    item:
      link id:
        v: p6.2.1
      text:
        v: Justification for Secondary Endpoints
item:
  link id:
    v: p6.3
  text:
    v: Tertiary Endpoints
  answer:
    value:
      v: [answer]
    item:
      link id:
        v: p6.3.1
      text:
        v: Justification for Tertiary Endpoints
item:
  link id:
    v: p6.4
  text:
    v: Primary Safety endpoints
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p6.5
  text:
    v: Secondary Safety endpoints
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p6.6
  text:
    v: Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.
  answer:
    value:
      v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p7
text:
  v: Study Design
item:
  link id:
    v: p7.1
  text:
    v: Overall Design
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.2
  text:
    v: Scientific Rationale for Study Design
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.3
  text:
    v: Justification for Dose
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.4
  text:
    v: Justification for Intervention
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.5
  text:
    v: End of Study Definition
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.6
  text:
    v: Screening Activities
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.7
  text:
    v: Study Intervention Activities
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.8
  text:
    v: Follow Up Activities
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.9
  text:
    v: Allocation to Interventional Group
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.10
  text:
    v: Study/Data Collection Instruments
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.11
  text:
    v: Research Setting
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p7.15
  text:
    v: Study Design Attachments
  item:
    link id:
      v: p7.15.1
    text:
      v: Describe the file that is being attached
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p7.15.2
    text:
      v: Attachment
    answer:
      value: Attachment

v: application/vnd.openxmlformats-officedocument.wordprocessingml.document

v: Example attachment.docx

v: 2022-02-27T22:24:16.963Z

link id:
  v: p8
text:
  v: Study Population
item:
  link id:
    v: p8.1
  text:
    v: Participant Selection
  item:
    link id:
      v: p8.1.2
    text:
      v: Age Range
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p8.1.3
    text:
      v: Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)
    answer:
      value:
        v: 150
  item:
    link id:
      v: p8.1.4
    text:
      v: Number Expected to Complete the Study or Needed to Address the Research Question
    answer:
      value:
        v: 100
  item:
    link id:
      v: p8.1.5
    text:
      v: Total Number of participants
    answer:
      value:
        v: 200
  item:
    link id:
      v: p8.1.6
    text:
      v: Overall study sample size (if multisite)
    answer:
      value:
        v: 500

link id:
  v: p9
text:
  v: Study Enrollment and Withdrawal
item:
  link id:
    v: p9.1
  text:
    v: Eligibility Criteria
  item:
    link id:
      v: p9.1.1
    text:
      v: Inclusion and Exclusion Criteria
    item:
      link id:
        v: p9.1.1.1
      text:
        v: Inclusion Criteria
    item:
      link id:
        v: p9.1.1.2
      text:
        v: Exclusion Criteria
  item:
    link id:
      v: p9.1.2
    text:
      v: Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination)
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p9.1.3
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p9.1.4
    text:
      v: Can study participants participate in another research study while participating in this research study
    answer:
      value: Coding
  item:
    link id:
      v: p9.1.5
    text:
      v: Screen Failures
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p9.1.6
    text:
      v: Lifestyle Considerations
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p9.1.7
    text:
      v: Vulnerable Populations
    item:
      link id:
        v: p9.1.7.1
      text:
        v: Can or will pregnant women be enrolled
      answer:
        value: Coding
    item:
      link id:
        v: p9.1.7.3
      text:
        v: Can or will the research involve neonates of uncertain viability or non-viable neonates?
      answer:
        value: Coding
    item:
      link id:
        v: p9.1.7.4
      text:
        v: Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?
      answer:
        value: Coding
    item:
      link id:
        v: p9.1.7.6
      text:
        v: 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:
        value: Coding
    item:
      link id:
        v: p9.1.7.7
      text:
        v: 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:
      link id:
        v: p9.1.7.8
      text:
        v: Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?
      answer:
        value: Coding
    item:
      link id:
        v: p9.1.7.10
      text:
        v: Can or will prisoners be enrolled?
      answer:
        value: Coding
    item:
      link id:
        v: p9.1.7.12
      text:
        v: Can or will students and/or employees be enrolled in this research?
      answer:
        value: Coding
    item:
      link id:
        v: p9.1.7.13
      text:
        v: Enrollment of students and/or employees
    item:
      link id:
        v: p9.1.7.14
      text:
        v: 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:
        value: Coding
item:
  link id:
    v: p9.2
  text:
    v: Strategies for Recruitment and Retention
  item:
    link id:
      v: p9.2.1
    text:
      v: Recruitment Methods
    item:
      link id:
        v: p9.2.1.1
      text:
        v: Describe when, where, and how potential participants will be recruited
    item:
      link id:
        v: p9.2.1.2
      text:
        v: When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.).
    item:
      link id:
        v: p9.2.1.3
      text:
        v: Describe source of participants (for example, patient population, local community, etc.)
    item:
      link id:
        v: p9.2.1.4
      text:
        v: Describe methods that will be used to identify potential participants
    item:
      link id:
        v: p9.2.1.5
      text:
        v: Describe how the recruitment methods described will be effective in attracting the targeted participant population
item:
  link id:
    v: p9.3
  text:
    v: Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.)
  answer:
    value:
      v: [answer]

v: [answer]

v: [answer]

v: Y

v: Yes

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

v: p9.1.7.7.1

v: 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

value:
  v: [answer]

v: p9.1.7.7.2

v: Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making

value:
  v: [answer]

v: p9.1.7.7.3

v: Describe any additional steps or procedures that will be used when performing informed consent with this population

value:
  v: [answer]

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: Y
display:
  v: Yes

v: p9.1.7.13.1

v: Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees

value:
  v: [answer]

v: p9.1.7.13.2

v: Describe how potential coercion will be eliminated

value:
  v: [answer]

v: p9.1.7.13.3

v: 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

value:
  v: [answer]

v: p9.1.7.13.4

v: Describe additional safeguards included to protect the rights and welfare of students and employees

value:
  v: [answer]

v: p9.1.7.13.5

v: 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

value:
  v: [answer]

v: p9.1.7.13.6

v: 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.

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: Y
  display:
    v: Yes

Coding
system:
  v: http://terminology.hl7.org/CodeSystem/v2-0532
code:
  v: N
display:
  v: No

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p10
text:
  v: Study Intervention
item:
  link id:
    v: p10.1
  text:
    v: Study Agent
  item:
    link id:
      v: p10.1.1
    text:
      v: Study Agent and Control Description
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.2
    text:
      v: Receipts/Acquisition
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.3
    text:
      v: Study Agent Accountability/ Return or Destruction of Investigational Product
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.4
    text:
      v: Formulation and appearance of Control Product
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.5
    text:
      v: Formulation and appearance of Test Product
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.6
    text:
      v: Packaging and Labeling
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.7
    text:
      v: Product Storage and Stability
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.8
    text:
      v: Preparation
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.9
    text:
      v: Administration and/or Dosing
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.10
    text:
      v: Route of Administration
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.11
    text:
      v: Starting Dose and Dose Escalation Schedule
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.12
    text:
      v: Dose Adjustments/Modifications/Delays
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.13
    text:
      v: Duration of Therapy
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.14
    text:
      v: Tracking Dose
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.15
    text:
      v: Device Specific Considerations
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.16
    text:
      v: Administration Instructions
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.17
    text:
      v: Dispensing [authority, requirements]
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.1.18
    text:
      v: Supply of Study Drug at the Site
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p10.3
  text:
    v: Study Procedural Intervention(s) Description
  item:
    link id:
      v: p10.3.1
    text:
      v: Administration of Procedural Intervention
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.3.2
    text:
      v: Procedures for Training of Clinicians on Procedural Intervention
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p10.3.3
    text:
      v: Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p10.4
  text:
    v: Participant Compliance and Monitoring
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p10.5
  text:
    v: Study Intervention/Experimental Manipulation Adherence
  answer:
    value:
      v: [answer]

link id:
  v: p11
text:
  v: Study Intervention Discontinuation and Participant Discontinuation/Withdrawal
item:
  link id:
    v: p11.1
  text:
    v: Discontinuation of Study Intervention
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p11.2
  text:
    v: Participant withdrawal and Termination
  item:
    link id:
      v: p11.2.1
    text:
      v: Reasons for Withdrawal or Termination
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p11.2.2
    text:
      v: Handling of Participant Withdrawal or Termination
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p11.2.3
    text:
      v: Replacement of participants
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p11.3
  text:
    v: Lost to Follow-Up
  answer:
    value:
      v: [answer]

link id:
  v: p12
text:
  v: Study Procedures
item:
  link id:
    v: p12.1
  text:
    v: Study Procedures/Evaluations
  item:
    link id:
      v: p12.1.1
    text:
      v: Study Specific Procedures
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p12.1.2
    text:
      v: Standard of Care Study Procedures
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p12.2
  text:
    v: Laboratory Procedures/Evaluations
  item:
    link id:
      v: p12.2.1
    text:
      v: Clinical Laboratory Evaluations
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p12.2.2
    text:
      v: Research Laboratory Evaluations
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p12.2.3
    text:
      v: Other Assays or Procedures
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p12.2.4
    text:
      v: Specimen Preparation, Handling, and Storage
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p12.2.5
    text:
      v: Specimen Shipment
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p12.3
  text:
    v: Data Collection and Follow Up for Withdrawn participants
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.4
  text:
    v: Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.5
  text:
    v: Precautionary Medications, Treatments, and Procedures
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.6
  text:
    v: Prohibited Medications, Treatments, and Procedures
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.7
  text:
    v: Prophylactic Medications, Treatments, and Procedures
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.8
  text:
    v: Rescue Medications, Treatments, and Procedures
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.9
  text:
    v: Participant Access to Study Agent at Study Closure
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p12.10
  text:
    v: Concomitant Medications, Treatments , and Procedures
  answer:
    value:
      v: [answer]

link id:
  v: p13
text:
  v: Schedule of Study Procedures
item:
  link id:
    v: p13.1
  text:
    v: Screening
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p13.2
  text:
    v: Enrollment/Visit 1/Baseline Visit
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p13.3
  text:
    v: Intermediate Visits
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p13.4
  text:
    v: Final Study Visit
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p13.5
  text:
    v: Withdrawal/Early Termination Visit
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p13.6
  text:
    v: Unscheduled Visit
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p13.7
  text:
    v: Follow Up Phase of the Study
  item:
    link id:
      v: p13.7.1
    text:
      v: Visit
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p13.7.2
    text:
      v: End of Study Visit
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p13.15
  text:
    v: Schedule of Study Procedures Attachments
  item:
    link id:
      v: p13.15.2
    text:
      v: Attachment
    answer:
      value: Attachment

v: application/vnd.openxmlformats-officedocument.wordprocessingml.document

v: Example attachment.docx

v: 2022-02-27T22:24:16.963Z

link id:
  v: p14
text:
  v: Assessment of Safety
item:
  link id:
    v: p14.1
  text:
    v: Specification of Safety Parameters
  item:
    link id:
      v: p14.1.1
    text:
      v: Definition of Adverse Events(AE)
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.1.2
    text:
      v: Definition of Serious Adverse Events (SAE)
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.1.3
    text:
      v: Definition of Unanticipated Problems
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p14.2
  text:
    v: Classification of an Adverse Event
  item:
    link id:
      v: p14.2.1
    text:
      v: Severity of an Event
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.2.2
    text:
      v: Relationship to Study Intervention/Experimental Manipulation
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.2.3
    text:
      v: Expectedness
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p14.3
  text:
    v: Time Period and Frequencey for Event Assessment and Follow-Up
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p14.4
  text:
    v: Reporting Procedures
  item:
    link id:
      v: p14.4.1
    text:
      v: Notifying the IRB
    item:
      link id:
        v: p14.4.1.1
      text:
        v: Adverse Event Reporting
    item:
      link id:
        v: p14.4.1.2
      text:
        v: Serious Adverse Event Reporting
    item:
      link id:
        v: p14.4.1.3
      text:
        v: Unanticipated Problem Reporting
    item:
      link id:
        v: p14.4.1.4
      text:
        v: Reporting of Pregnancy
  item:
    link id:
      v: p14.4.2
    text:
      v: Notifyiing the Study Sponsor
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.4.3
    text:
      v: Notifying the FDA
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.4.4
    text:
      v: Notifying Participating Investigators
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.4.5
    text:
      v: Reporting Events to Participants
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p14.4.6
    text:
      v: Events of Special Interest
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p14.5
  text:
    v: Follow Up Report
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p14.6
  text:
    v: Study Halting/Stopping Rules
  answer:
    value:
      v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p15
text:
  v: Statistical Considerations
item:
  link id:
    v: p15.1
  text:
    v: Statistical and Analytical Plans(SAP)
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p15.2
  text:
    v: Statistical Hypotheses
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p15.3
  text:
    v: Analysis Datasets
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p15.4
  text:
    v: Populations for Analysis
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p15.5
  text:
    v: Sample Size Determination
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p15.6
  text:
    v: Description of Statistical Methods
  item:
    link id:
      v: p15.6.1
    text:
      v: General Approach
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.2
    text:
      v: Analysis of Primary Efficacy Endpoints(s)
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.3
    text:
      v: Analysis of Secondary Endpoint(s)
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.4
    text:
      v: Safety Analyses
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.5
    text:
      v: Adherence and Retention Analyses
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.6
    text:
      v: Baseline Descriptive Statistics
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.7
    text:
      v: Planned Interim Analyses
    item:
      link id:
        v: p15.6.7.1
      text:
        v: Safety Review
    item:
      link id:
        v: p15.6.7.2
      text:
        v: Efficacy Review
  item:
    link id:
      v: p15.6.8
    text:
      v: Additional Sub-Group Analyses
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.9
    text:
      v: Multiple Comparison/Multiplicity
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.10
    text:
      v: Tabulation of Individual Response Data
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.11
    text:
      v: Exploratory Analyses
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.6.12
    text:
      v: Pharmacokinetic Analysis (if applicable)
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p15.7
  text:
    v: Sample Size
  answer:
    value:
      v: 100
item:
  link id:
    v: p15.8
  text:
    v: Measures to Minimize Bias
  item:
    link id:
      v: p15.8.1
    text:
      v: Enrollment/Randomization/Masking Procedures
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.8.2
    text:
      v: Evaluation of Success of Blinding
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p15.8.3
    text:
      v: Breaking the Study Blind/Participant Code
    answer:
      value:
        v: [answer]

v: [answer]

v: [answer]

link id:
  v: p16
text:
  v: Supporting Documentation and Operational Considerations
item:
  link id:
    v: p16.1
  text:
    v: Regulatory, Ethical and Study Oversight Considerations
  item:
    link id:
      v: p16.1.1
    text:
      v: Protocol Amendments
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.2
    text:
      v: Ethical Standard
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.3
    text:
      v: Institutional Review Board
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.4
    text:
      v: Informed Consent Process
    item:
      link id:
        v: p16.1.4.1
      text:
        v: Consent/Assent and Other Informational Documents Provided to Participants
    item:
      link id:
        v: p16.1.4.2
      text:
        v: Consent Procedures and Documentation
    item:
      link id:
        v: p16.1.4.3
      text:
        v: Indicate where the consent process will take place.
  item:
    link id:
      v: p16.1.5
    text:
      v: Participant data and Confidentialty
    item:
      link id:
        v: p16.1.5.1
      text:
        v: Research Use of Stored Human Samples, Specimens, or Data
    item:
      link id:
        v: p16.1.5.2
      text:
        v: Confidentiality of Research Biospeciemen/Data
    item:
      link id:
        v: p16.1.5.3
      text:
        v: Certificate of Confidentiality (if applicable)
    item:
      link id:
        v: p16.1.5.4
      text:
        v: Provisions to Protect the Privacy of Participants
  item:
    link id:
      v: p16.1.6
    text:
      v: Future Use of Stored Human Specimens and Data
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.7
    text:
      v: Study Discontinuation and Closure
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.8
    text:
      v: Key Roles and Expertise of Study Team
    item:
      link id:
        v: p16.1.8.1
      text:
        v: First Name
    item:
      link id:
        v: p16.1.8.2
      text:
        v: Last Name
    item:
      link id:
        v: p16.1.8.3
      text:
        v: Position/Title
    item:
      link id:
        v: p16.1.8.4
      text:
        v: Responsibilities
  item:
    link id:
      v: p16.1.8
    text:
      v: Key Roles and Expertise of Study Team
    item:
      link id:
        v: p16.1.8.1
      text:
        v: First Name
    item:
      link id:
        v: p16.1.8.2
      text:
        v: Last Name
    item:
      link id:
        v: p16.1.8.3
      text:
        v: Position/Title
    item:
      link id:
        v: p16.1.8.4
      text:
        v: Responsibilities
  item:
    link id:
      v: p16.1.8
    text:
      v: Key Roles and Expertise of Study Team
    item:
      link id:
        v: p16.1.8.1
      text:
        v: First Name
    item:
      link id:
        v: p16.1.8.2
      text:
        v: Last Name
    item:
      link id:
        v: p16.1.8.3
      text:
        v: Position/Title
    item:
      link id:
        v: p16.1.8.4
      text:
        v: Responsibilities
  item:
    link id:
      v: p16.1.8
    text:
      v: Key Roles and Expertise of Study Team
    item:
      link id:
        v: p16.1.8.1
      text:
        v: First Name
    item:
      link id:
        v: p16.1.8.2
      text:
        v: Last Name
    item:
      link id:
        v: p16.1.8.3
      text:
        v: Position/Title
    item:
      link id:
        v: p16.1.8.4
      text:
        v: Responsibilities
  item:
    link id:
      v: p16.1.9
    text:
      v: Safety Oversight
    answer:
      value:
        v: [answer]

v: [answer]

v: p16.1.4.2.1

v: Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research

value:
  v: [answer]

v: p16.1.4.2.2

v: Describe the parental permission process and the child assent process. (If study involves children)

value:
  v: [answer]

v: p16.1.4.2.3

v: 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

value:
  v: [answer]

v: p16.1.4.2.4

v: Methods of Informed Consent for non-English Speakers

value:
  v: [answer]

v: p16.1.4.2.5

v: Waiver or Alteration of Consent Process

value:
  v: [answer]

v: p16.1.4.2.6

v: HIPAA Authorization

link id:
  v: p16.1.4.2.6.1
text:
  v: Participant's Capacity to Give Legally Effective Consent
answer:
  value:
    v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: [answer]

link id:
  v: p16.1.10
text:
  v: Clinical Monitoring
answer:
  value:
    v: [answer]

link id:
  v: p16.1.11
text:
  v: Quality Assurance and Quality Control
answer:
  value:
    v: [answer]

link id:
  v: p16.1.12
text:
  v: Data Handling and Record Keeping
item:
  link id:
    v: p16.1.12.1
  text:
    v: Data Quality Control and Reporting
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p16.1.12.2
  text:
    v: Data Collection and Management Responsibilities
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p16.1.12.3
  text:
    v: Data Archival
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p16.1.12.4
  text:
    v: Study Records Retention
  item:
    link id:
      v: p16.1.12.4.1
    text:
      v: Photographs, Audio/Video Recordings Retention
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.12.4.2
    text:
      v: Data and/or Biological Specimens Access
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p16.1.12.4.3
    text:
      v: Data and/or Biological Specimens Retention/Banking
    answer:
      value:
        v: [answer]

link id:
  v: p16.1.13
text:
  v: Protocol Deviations
answer:
  value:
    v: [answer]

link id:
  v: p16.1.14
text:
  v: Publication and Data Sharing Policy
answer:
  value:
    v: [answer]

link id:
  v: p16.1.15
text:
  v: Conflict of Interest Policy
answer:
  value:
    v: [answer]

link id:
  v: p16.1.16
text:
  v: Source Documents and Access to Source Data/Documents
answer:
  value:
    v: [answer]

link id:
  v: p16.1.17
text:
  v: Collections of Photographs, or Audio/Video Recording
answer:
  value:
    v: [answer]

link id:
  v: p16.2
text:
  v: Prior Approvals/Attachments Requiring Signatures
item:
  link id:
    v: p16.2.1
  text:
    v: Prior Approvals/Attachments Requiring Signatures
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p16.2.2
  text:
    v: Attachment
  answer:
    value: Attachment
      content type:
        v: application/vnd.openxmlformats-officedocument.wordprocessingml.document
      title:
        v: Example attachment.docx
      creation:
        v: 2022-02-27T22:24:16.963Z

link id:
  v: p16.3
text:
  v: Additional Considerations
answer:
  value:
    v: [answer]

link id:
  v: p16.4
text:
  v: Abbreviations and Special Terms
answer:
  value:
    v: [answer]

link id:
  v: p16.5
text:
  v: Other Supporting Documentation and Operational Considerations Attachments
item:
  link id:
    v: p16.5.1
  text:
    v: Describe the file that is being attached (optional)
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p16.5.2
  text:
    v: Attachment
  answer:
    value: Attachment
      content type:
        v: application/vnd.openxmlformats-officedocument.wordprocessingml.document
      title:
        v: Example attachment.docx
      creation:
        v: 2022-02-27T22:24:16.963Z

link id:
  v: p17
text:
  v: Study Administration
item:
  link id:
    v: p17.1
  text:
    v: Setting
  item:
    link id:
      v: p17.1.1
    text:
      v: Describe the sites / locations where your research team will conduct the research
    answer:
      value:
        v: [answer]
item:
  link id:
    v: p17.2
  text:
    v: Registration
  item:
    link id:
      v: p17.2.1
    text:
      v: 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:
      value:
        v: [answer]
item:
  link id:
    v: p17.3
  text:
    v: Resources Available
  item:
    link id:
      v: p17.3.1
    text:
      v: Describe the roles/tasks of each research team member
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p17.3.2
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p17.3.3
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p17.3.4
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p17.3.5
    text:
      v: Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study?
    answer:
      value: Coding
item:
  link id:
    v: p17.4
  text:
    v: IRB Review
  item:
    link id:
      v: p17.4.1
    text:
      v: An appropriate IRB , registered with the OHRP ,review and approve this study.
    answer:
      value: Coding
  item:
    link id:
      v: p17.4.2
    text:
      v: 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:
      value: Coding
item:
  link id:
    v: p17.5
  text:
    v: Community-Based Participatory Research/Field Research
  item:
    link id:
      v: p17.5.1
    text:
      v: Can or will this study involve community-based participatory research?
    answer:
      value: Coding
  item:
    link id:
      v: p17.5.2
    text:
      v: Community-based participatory research
    item:
      link id:
        v: p17.5.2.1
      text:
        v: Describe the communities that will be involved in this research
    item:
      link id:
        v: p17.5.2.2
      text:
        v: Describe the composition and involvement of any community advisory board
    item:
      link id:
        v: p17.5.2.3
      text:
        v: Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research
    item:
      link id:
        v: p17.5.2.4
      text:
        v: Describe the plans on dissemination and publication of study results which are in agreement with the community
item:
  link id:
    v: p17.6
  text:
    v: Multi Site Research
  item:
    link id:
      v: p17.6.1
    text:
      v: Describe the plan for tracking IRB approval of documents and consent forms for each site
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p17.6.2
    text:
      v: Name of the sponsor(s) and Contract Research Organization (CRO)
    item:
      link id:
        v: ExternalDataFor_p17.6.2.1
      text:
        v: External Data For linkId p17.6.2.1
    item:
      link id:
        v: p17.6.2.1
      text:
        v: Name of the sponsor(s)
      answer:
        value: Coding
      answer:
        value: Coding
    item:
      link id:
        v: p17.6.2.2
      text:
        v: Name of the Contract Research Organization (CRO)
  item:
    link id:
      v: p17.6.3
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p17.6.4
    text:
      v: Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p17.6.5
    text:
      v: Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p17.6.6
    text:
      v: 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:
      value:
        v: [answer]
  item:
    link id:
      v: p17.6.7

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: [answer]

v: [answer]

v: [answer]

v: [answer]

v: National Government Funder

v: Organization of Arthritis Patients Foundation

Coding
display:
  v: National Government Funder

Coding
display:
  v: Organization of Arthritis Patients Foundation

v: Sample CRO, Inc.

v: Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations

link id:
  v: p17.6.7.1
text:
  v: 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:
  value:
    v: [answer]

link id:
  v: p17.6.7.2
text:
  v: Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?
answer:
  value:
    v: [answer]

link id:
  v: p17.6.8
text:
  v: 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:
  value:
    v: [answer]

link id:
  v: p17.6.9
text:
  v: Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable)
item:
  link id:
    v: p17.6.9.1
  text:
    v: Describe how they will be provided to each enrolling site
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p17.6.9.2
  text:
    v: Describe how dispensing will be monitored
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p17.6.9.3
  text:
    v: Describe what investigational product accountability procedures will be implemented
  answer:
    value:
      v: [answer]

link id:
  v: p17.6.10
text:
  v: Describe the procedures for study closures and early site termination
answer:
  value:
    v: [answer]

link id:
  v: p17.6.11
text:
  v: 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:
  value:
    v: [answer]

link id:
  v: p17.7
text:
  v: Key Roles and Study Governance
answer:
  value:
    v: [answer]

link id:
  v: p18
text:
  v: Study Finances
item:
  link id:
    v: p18.1
  text:
    v: Funding Source
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p18.2
  text:
    v: Costs to the participant
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p18.3
  text:
    v: Participant Reimbursements or Payments
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p18.4
  text:
    v: Compensation for Research-Related Injury
  answer:
    value:
      v: [answer]

link id:
  v: p19
text:
  v: References
item:
  link id:
    v: p19.1
  text:
    v: List any references here, unless already cited.
  answer:
    value:
      v: [answer]
item:
  link id:
    v: p19.2
  text:
    v: Reference list attachment (optional)
  item:
    link id:
      v: p19.2.2
    text:
      v: Attachment
    answer:
      value: Attachment

v: application/vnd.openxmlformats-officedocument.wordprocessingml.document

v: Example attachment.docx

v: 2022-02-27T22:24:16.963Z

link id:
  v: p25
text:
  v: Other Attachments to the Protocol
item:
  link id:
    v: p25.1
  text:
    v: Other Attachment(s) to the Protocol
  item:
    link id:
      v: p25.1.1
    text:
      v: Describe the file that is being attached
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p25.1.2
    text:
      v: Attachment
    answer:
      value: Attachment
item:
  link id:
    v: p25.1
  text:
    v: Other Attachment(s) to the Protocol
  item:
    link id:
      v: p25.1.1
    text:
      v: Describe the file that is being attached
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: p25.1.2
    text:
      v: Attachment
    answer:
      value: Attachment

v: application/vnd.openxmlformats-officedocument.wordprocessingml.document

v: Example attachment.docx

v: 2022-02-27T22:24:16.963Z

v: application/vnd.openxmlformats-officedocument.wordprocessingml.document

v: Example attachment.docx

v: 2022-02-27T22:24:16.963Z

link id:
  v: ADMIN00
text:
  v: Administrative Use Only
item:
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  answer:
    value:
      v: p
item:
  link id:
    v: ADMIN02
  text:
    v: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
  answer:
    value:
      v: initiate-study-populate-exampleQR
item:
  link id:
    v: ADMIN03
  text:
    v: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any
  answer:
    value:
      v: ResearchStudyExample-sIRB