Package | hl7.fhir.us.sirb |
Type | Questionnaire |
Id | Id |
FHIR Version | R4 |
Source | http://hl7.org/fhir/us/sirb/https://build.fhir.org/ig/HL7/fhir-sirb/Questionnaire-sirb-consent-questionnaire-populate.html |
Url | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate |
Version | 1.0.0 |
Status | draft |
Date | 2023-04-24T20:03:27+00:00 |
Name | Consent_Questionnaire |
Title | Consent Questionnaire |
Experimental | False |
Realm | us |
Authority | hl7 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
LinkId | Text | Cardinality | Type | Flags | Description & Constraints |
---|---|---|---|---|---|
Consent_Questionnaire | Questionnaire | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate#1.0.0 | |||
c1 | Research Study | 0..1 | group | ||
c1.1 | Study Title | 0..1 | text | Expressions:
| |
c1.1_help | Short Title of the Research Study | 0..1 | display | ||
c1.2 | IRB Protocol Number | 0..1 | string | Expressions:
| |
c38 | Study Site | 0..1 | group | ||
ExternalDataFor_c38.1 | External Data For linkId c38.1 | 0..* | open-choice | Expressions:
| |
c38.1 | Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below. | 0..1 | choice | ||
c38.1_help | This question and its answer will not print on the Consent Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details. | 0..1 | display | ||
c38.2 | Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI? | 1..1 | choice | Options: 2 options Expressions:
| |
c38.2_help | This question and its answer will not print on the Consent Form but are necessary for the form logic. | 0..1 | display | ||
c40 | Study Site Principal Investigator and Study Site | 0..1 | group | ||
c40.1 | Multi-site statement | 0..1 | text | Initial Value: string = This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed. | |
c40.2 | Statement for Consent Form at Lead PI Site | 0..1 | text | Enable When: c38.2 = Yes (expandedYes-NoIndicator#Y) Initial Value: string = In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The site where you are participating in the study is the lead or main site. The lead study site is responsible for all study activities for the overall study. The principal investigator(PI) is responsible for the conduct of the study. The PI for your study is the lead principal investigator, responsible for the overall study. | |
c40.3 | Statement for Consent Form at Relying Site (not Lead PI Site) | 0..1 | text | Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) Initial Value: string = This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site. | |
c40.5 | Principal Investigator at Study Site | 0..1 | group | ||
c40.5.2 | First Name | 0..1 | string | Expressions:
| |
c40.5.2_help | First or given name of the relying site PI | 0..1 | display | ||
c40.5.1 | Last Name | 0..1 | string | Expressions:
| |
c40.5.1_help | Surname or family name of the relying site PI | 0..1 | display | ||
c40.5.6 | Suffix | 0..1 | string | Expressions:
| |
c40.5.6_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display | ||
c40.5.3 | Degree(s) | 0..1 | string | Expressions:
| |
c40.5.3_help | Professional and Academic degrees of the relying site PI | 0..1 | display | ||
c40.5.4 | Associated Institution | 0..1 | string | Expressions:
| |
c40.5.4_help | Relying site PI's Academic or Professional Institution | 0..1 | display | ||
c40.5.8 | Contact Information | 0..1 | group | ||
c40.5.8.20 | Phone | 0..1 | string | Expressions:
| |
c40.5.8.20_help | 10-digit phone number, including area code | 0..1 | display | ||
c40.5.8.21 | 0..1 | string | Expressions:
| ||
c40.5.8_help | Information on how to contact the Site PI. | 0..1 | display | ||
c40.5_help | Principal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site | 0..1 | display | ||
c40.9 | Study Site Institution | 0..1 | group | ||
c40.9.1 | Institution Name | 0..1 | string | Expressions:
| |
c40.9.1_help | Public or private entity conducting the study- where the participant will go or call | 0..1 | display | ||
c40.9.2 | Address | 0..1 | group | ||
c40.9.2.10 | Street Address | 0..1 | string | Expressions:
| |
c40.9.2.11 | City | 0..1 | string | Expressions:
| |
c40.9.2.12 | State | 0..1 | string | Expressions:
| |
c40.9.2.13 | Zip Code | 0..1 | string | Expressions:
| |
c40.9.2.14 | Country | 0..1 | string | Expressions:
| |
c40.9_help | Information about institution for the site where study will be conducted | 0..1 | display | ||
c49 | Lead Principal Investigator and Lead Principal Investigator Site | 0..1 | group | Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) | |
c49.1 | Statement about Lead PI and Lead PI Site for Consent Form at Relying Site | 0..1 | text | Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) Initial Value: string = In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information. | |
c49.2 | Lead Principal Investigator | 0..1 | group | ||
c49.2.2 | First Name | 0..1 | string | Expressions:
| |
c49.2.2_help | First or given name of the lead PI | 0..1 | display | ||
c49.2.1 | Last Name | 0..1 | string | Expressions:
| |
c49.2.1_help | Surname or family name of the lead PI | 0..1 | display | ||
c49.2.6 | Suffix | 0..1 | string | Expressions:
| |
c49.2.6_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display | ||
c49.2.3 | Degree(s) | 0..1 | string | Expressions:
| |
c49.2.3_help | Professional and Academic degrees of the lead PI | 0..1 | display | ||
c49.2.5 | Contact Information | 0..1 | group | ||
c49.2.5.20 | Phone | 0..1 | string | Expressions:
| |
c49.2.5.20_help | 10-digit phone number, including area code | 0..1 | display | ||
c49.2.5.21 | 0..1 | string | Expressions:
| ||
c49.2.5_help | Information on how to contact the Lead PI. | 0..1 | display | ||
c49.2_help | Person(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial. | 0..1 | display | ||
c49.5 | Lead Principal Investigator Institution | 0..1 | group | Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) | |
c49.5.1 | Name | 0..1 | string | Expressions:
| |
c49.5.1_help | Public or private entity associated with the lead principal investigator conducting the overall study. | 0..1 | display | ||
c49.5.2 | Address | 0..1 | group | ||
c49.5.2.10 | Street Address | 0..1 | string | Expressions:
| |
c49.5.2.11 | City | 0..1 | string | Expressions:
| |
c49.5.2.12 | State | 0..1 | string | Expressions:
| |
c49.5.2.13 | Zip Code | 0..1 | string | Expressions:
| |
c49.5.2.14 | Country | 0..1 | string | Expressions:
| |
c49.5_help | Information about Lead Institution | 0..1 | display | ||
c4 | Sponsor or Funding Source | 0..1 | group | ||
ExternalDataFor_c4.1 | External Data For linkId c4.1 | 0..* | open-choice | Expressions:
| |
c4.1 | Sponsor Name | 0..* | open-choice | ||
c4.1_help | Entity financially supporting the research | 0..1 | display | ||
c5 | Sponsor Detail | 0..1 | text | ||
c5_help | Any additional relevant information about the sponsor(s) | 0..1 | display | ||
c6 | Is this consent an eConsent? | 0..1 | choice | Options: 2 options | |
c6_help | Consent that is obtained electronically | 0..1 | display | ||
c7 | Summary Text | 0..1 | group | ||
c7.1 | Summary Text Statement | 1..1 | text | ||
c7.1_help | Describes the basic purpose, procedures and reasons behind the research in easily understood prose | 0..1 | display | ||
c7_help | Section header for the mandated text describing the basic purpose, procedures and reasons for the study. | 0..1 | display | ||
c8 | Introduction and Statement of Research | 0..1 | group | ||
c8.1 | About Consent Form | 0..1 | text | Initial Value: string = This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate. | |
c8_help | Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process. | 0..1 | display | ||
c9 | Purpose | 0..1 | group | ||
c9.1 | Reason for Research | 0..1 | text | ||
c9.1_help | Explanation about why the study is being conducted | 0..1 | display | ||
c9.2 | Interactions with others | 0..1 | text | ||
c9.2_help | Statement of whom the participant can anticipate interacting with during study participation | 0..1 | display | ||
c9.3 | Invited Participants | 0..1 | text | ||
c9.3_help | High level information about what participating in the study will entail for the participant | 0..1 | display | ||
c9.4 | Total expected study enrollment | 0..1 | integer | ||
c9.4_help | The total number of people targeted for enrollment in the multi-site study | 0..1 | display | ||
c9.5 | Additional Enrollment Text | 0..1 | text | ||
c9.5_help | Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site | 0..1 | display | ||
c9.6 | What is involved in the study? | 0..1 | text | ||
c9.6_help | High level information about what participating in the study will entail for the participant. | 0..1 | display | ||
c10 | Assessments | 0..1 | group | ||
c10.1 | Assessment List | 0..* | group | ||
c10.1.1 | Name of the Assessment | 0..1 | string | ||
c10.1.1_help | Short name of the assessment | 0..1 | display | ||
c10.1.2 | Description of Assessment | 0..1 | text | ||
c10.1.2_help | Short description of the assessment | 0..1 | display | ||