Questionnaire-sirb-consent-questionnaire-populate

Sourcehl7.fhir.us.sirb#current:Single Institutional Review Board (sIRB) Implementation Guide (v4.0.1)
resourceTypeQuestionnaire
idsirb-consent-questionnaire-populate
canonicalhttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate
version1.0.0
statusdraft
publisherHL7 International - BR&R Work Group
nameConsent_Questionnaire
titleConsent Questionnaire
date2023-03-29T06:17:19+00:00
jurisdictionsus
Usages(none)

Research Study

  • linkId: c1

Study Title

  • linkId: c1.1

Short Title of the Research Study

  • linkId: c1.1_help

IRB Protocol Number

  • linkId: c1.2

Study Site

  • linkId: c38

External Data For linkId c38.1

  • Flags: icon
  • linkId: ExternalDataFor_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.

  • linkId: c38.1

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.

  • linkId: c38.1_help

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? *

This question and its answer will not print on the Consent Form but are necessary for the form logic.

  • linkId: c38.2_help

Study Site Principal Investigator and Study Site

  • linkId: c40

Multi-site statement

  • linkId: c40.1
  • Initial Values: 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.

Statement for Consent Form at Lead PI Site

  • linkId: c40.2
  • Enable When: todo
  • Initial Values: 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.

Statement for Consent Form at Relying Site (not Lead PI Site)

  • linkId: c40.3
  • Enable When: todo
  • Initial Values: 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.

Principal Investigator at Study Site

  • linkId: c40.5

First Name

  • linkId: c40.5.2

First or given name of the relying site PI

  • linkId: c40.5.2_help

Last Name

  • linkId: c40.5.1

Surname or family name of the relying site PI

  • linkId: c40.5.1_help

Suffix

  • linkId: c40.5.6

Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.

  • linkId: c40.5.6_help

Degree(s)

  • linkId: c40.5.3

Professional and Academic degrees of the relying site PI

  • linkId: c40.5.3_help

Associated Institution

  • linkId: c40.5.4

Relying site PI's Academic or Professional Institution

  • linkId: c40.5.4_help

Contact Information

  • linkId: c40.5.8

Phone

  • linkId: c40.5.8.20

10-digit phone number, including area code

  • linkId: c40.5.8.20_help

Email

  • linkId: c40.5.8.21

Information on how to contact the Site PI.

  • linkId: c40.5.8_help

Principal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site

  • linkId: c40.5_help

Study Site Institution

  • linkId: c40.9

Institution Name

  • linkId: c40.9.1

Public or private entity conducting the study- where the participant will go or call

  • linkId: c40.9.1_help

Address

  • linkId: c40.9.2

Street Address

  • linkId: c40.9.2.10

City

  • linkId: c40.9.2.11

State

  • linkId: c40.9.2.12

Zip Code

  • linkId: c40.9.2.13

Country

  • linkId: c40.9.2.14

Information about institution for the site where study will be conducted

  • linkId: c40.9_help

Lead Principal Investigator and Lead Principal Investigator Site

  • linkId: c49
  • Enable When: todo

Statement about Lead PI and Lead PI Site for Consent Form at Relying Site

  • linkId: c49.1
  • Enable When: todo
  • Initial Values: 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.

Lead Principal Investigator

  • linkId: c49.2

First Name

  • linkId: c49.2.2

First or given name of the lead PI

  • linkId: c49.2.2_help

Last Name

  • linkId: c49.2.1

Surname or family name of the lead PI

  • linkId: c49.2.1_help

Suffix

  • linkId: c49.2.6

Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.

  • linkId: c49.2.6_help

Degree(s)

  • linkId: c49.2.3

Professional and Academic degrees of the lead PI

  • linkId: c49.2.3_help

Contact Information

  • linkId: c49.2.5

Phone

  • linkId: c49.2.5.20

10-digit phone number, including area code

  • linkId: c49.2.5.20_help

Email

  • linkId: c49.2.5.21

Information on how to contact the Lead PI.

  • linkId: c49.2.5_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.

  • linkId: c49.2_help

Lead Principal Investigator Institution

  • linkId: c49.5
  • Enable When: todo

Name

  • linkId: c49.5.1

Public or private entity associated with the lead principal investigator conducting the overall study.

  • linkId: c49.5.1_help

Address

  • linkId: c49.5.2

Street Address

  • linkId: c49.5.2.10

City

  • linkId: c49.5.2.11

State

  • linkId: c49.5.2.12

Zip Code

  • linkId: c49.5.2.13

Country

  • linkId: c49.5.2.14

Information about Lead Institution

  • linkId: c49.5_help

Sponsor or Funding Source

  • linkId: c4

External Data For linkId c4.1

  • Flags: icon
  • linkId: ExternalDataFor_c4.1

Sponsor Name

  • linkId: c4.1

Entity financially supporting the research

  • linkId: c4.1_help

Sponsor Detail

  • linkId: c5

Any additional relevant information about the sponsor(s)

  • linkId: c5_help

Is this consent an eConsent?

Consent that is obtained electronically

  • linkId: c6_help

Summary Text

  • linkId: c7

Summary Text Statement *

  • linkId: c7.1

Describes the basic purpose, procedures and reasons behind the research in easily understood prose

  • linkId: c7.1_help

Section header for the mandated text describing the basic purpose, procedures and reasons for the study.

  • linkId: c7_help

Introduction and Statement of Research

  • linkId: c8

About Consent Form

  • linkId: c8.1
  • Initial Values: 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.

Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process.

  • linkId: c8_help

Purpose

  • linkId: c9

Reason for Research

  • linkId: c9.1

Explanation about why the study is being conducted

  • linkId: c9.1_help

Interactions with others

  • linkId: c9.2

Statement of whom the participant can anticipate interacting with during study participation

  • linkId: c9.2_help

Invited Participants

  • linkId: c9.3

High level information about what participating in the study will entail for the participant

  • linkId: c9.3_help

Total expected study enrollment

  • linkId: c9.4

The total number of people targeted for enrollment in the multi-site study

  • linkId: c9.4_help

Additional Enrollment Text

  • linkId: c9.5

Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site

  • linkId: c9.5_help

What is involved in the study?

  • linkId: c9.6

High level information about what participating in the study will entail for the participant.

  • linkId: c9.6_help

Assessments

  • linkId: c10

Assessment List

  • linkId: c10.1

Name of the Assessment

  • linkId: c10.1.1

Short name of the assessment

  • linkId: c10.1.1_help

Description of Assessment

  • linkId: c10.1.2

Short description of the assessment

  • linkId: c10.1.2_help

  • linkId: c10.31

Assessment Supplemental Text

  • linkId: c10.2

Additional text to provide additional context about the assessments collected

  • linkId: c10.2_help

  • linkId: c10.32

Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?

If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Assessment List" table in the questionnaire.

  • linkId: c10.3_help

Assessment List Attachment(s)

  • linkId: c10.4
  • Enable When: todo

Describe the file that is being attached (optional)

  • linkId: c10.4.1

Upload attachment(s) here.

  • linkId: c10.4.2

  • linkId: c10.33

Visits and Procedures

  • linkId: c11

Visit Introductory Text

  • linkId: c11.1

Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule.

  • linkId: c11.1_help

Visit List

  • linkId: c11.2

Visit Type

  • linkId: c11.2.1

Unique visit type, defined by the procedures which are completed within that visit. E.g. Screening, Baseline, Followup, Final

  • linkId: c11.2.1_help

Visit Description

  • linkId: c11.2.2

Description of Visit types, including what procedures it contains

  • linkId: c11.2.2_help

Visit Duration

  • linkId: c11.2.3

Visit Duration Units

Choices for visit duration units are minutes (min), hours (h) or days (d).

  • linkId: c11.2.4_help

Number of Visits

  • linkId: c11.2.5

  • linkId: c11.31

Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?

If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Visit List" table in the questionnaire.

  • linkId: c11.6_help

Visit List Attachment(s)

  • linkId: c11.7
  • Enable When: todo

Describe the file that is being attached (optional)

  • linkId: c11.7.1

Upload attachment(s) here.

  • linkId: c11.7.2

  • linkId: c11.32

Procedure List

  • linkId: c11.3

Name of Procedure

  • linkId: c11.3.1

Common Term of Procedure

  • linkId: c11.3.2

Description of a Procedure

  • linkId: c11.3.3

Experimental Procedure Indicator

Research Indicator

Frequency

  • linkId: c11.3.6

Specify the procedure frequency and the applicable frequency units. For example, 4 times per year or 2 times per week.

  • linkId: c11.3.6_help

Procedure Duration (minutes)

  • linkId: c11.3.9

Specify the procedure duration in minutes

  • linkId: c11.3.9_help

  • linkId: c11.33

Procedure Supplemental Text

  • linkId: c11.4

Additional Text to include after the procedure table to provide the participant with any additional information needed about procedure schedule

  • linkId: c11.4_help

  • linkId: c11.34

Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?

If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.

  • linkId: c11.9_help

Procedure List Attachment(s)

  • linkId: c11.10
  • Enable When: todo

Describe the file that is being attached (optional)

  • linkId: c11.10.1

Upload attachment(s) here.

  • linkId: c11.10.2

  • linkId: c11.35

Total Duration of Study Participation

  • linkId: c11.5

Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion

  • linkId: c11.5_help

Risks

  • linkId: c12

Risk List

  • linkId: c12.1

Name of the risk

  • linkId: c12.1.1

Description of Risk

  • linkId: c12.1.2

Risk Category

  • linkId: c12.33

Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?

If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Risk List" table in the questionnaire.

  • linkId: c12.9_help

Risk List Attachment(s)

  • linkId: c12.10
  • Enable When: todo

Describe the file that is being attached (optional)

  • linkId: c12.10.1

Upload attachment(s) here.

  • linkId: c12.10.2

  • linkId: c12.37

Risk Supplemental Text

  • linkId: c12.2

Additional text for description of other risks

  • linkId: c12.2_help

Fetal Risks

Indicates whether risks to the fetus are possible

  • linkId: c12.3_help

Fetal Risk Details

  • linkId: c12.4
  • Enable When: todo

Textual description of risks to the fetus

  • linkId: c12.4_help

Alternative Procedures

  • linkId: c13

Alternative Procedure Text

  • linkId: c13.1

Describe any other treatment/procedure that may be used other than those described for study participation.

  • linkId: c13.1_help

Benefits

  • linkId: c14

Benefits List

  • linkId: c14.1

Name of Benefit

  • linkId: c14.1.1

Description of Benefit

  • linkId: c14.1.2

Benefit to you

Benefit to society

  • linkId: c14.31

Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?

If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.

  • linkId: c14.9_help

Benefits List Attachment(s)

  • linkId: c14.10
  • Enable When: todo

Describe the file that is being attached (optional)

  • linkId: c14.10.1

Upload attachment(s) here.

  • linkId: c14.10.2

  • linkId: c14.33

Compensation

  • linkId: c15

Will there be compensation for participation?

Indicates whether compensation will be offered or not for the study

  • linkId: c15.1_help

Compensation Supplemental Text

  • linkId: c15.2
  • Enable When: todo

Additional text about compensation not captured in the compensation table

  • linkId: c15.2_help

Compensation List

  • linkId: c15.3
  • Enable When: todo

What types of visits or milestones will I be compensated for?

  • linkId: c15.3.1

How many visits or milestones of this type will there be compensation for?

  • linkId: c15.3.2

How much will be paid per that type of visit?

  • linkId: c15.3.3

  • linkId: c15.33

Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?

If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Compensation List" table in the questionnaire.

  • linkId: c15.5_help

Compensation List Attachment(s)

  • linkId: c15.7
  • Enable When: todo

Describe the file that is being attached (optional)

  • linkId: c15.7.1

Upload attachment(s) here.

  • linkId: c15.7.2

  • linkId: c15.35

Costs

  • linkId: c16

What are the costs of participation, if any?

  • linkId: c16.1

Explanation informing participant if any additional costs will occur to the participant as a result of taking part in the study

  • linkId: c16.1_help

Will there be reimbursement for other study visit costs incurred?

Reimbursement to participant for other study visit costs not directly associated with a visit

  • linkId: c16.2_help

Will costs be covered for medical treatment if research related injury occurs?

Indicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury

  • linkId: c16.3_help

Additional description of treatment coverage

  • linkId: c16.4

Description of other costs not directly associated with a visit

  • linkId: c16.4_help

Participant Rights and whom to contact for answers

  • linkId: c17

What are the rights of a participant?

  • linkId: c17.1

Statement of particpant rights

  • linkId: c17.1_help

Site IRB Contact Information

  • linkId: c17.2

IRB Contact Name

  • linkId: c17.2.1

IRB Name

  • linkId: c17.2.8

Department Name or Division

  • linkId: c17.2.9

Street Address

  • linkId: c17.2.10

City

  • linkId: c17.2.11

State

  • linkId: c17.2.12

Zip Code

  • linkId: c17.2.13

Country

  • linkId: c17.2.14

Phone

  • linkId: c17.2.20

10-digit phone number, including area code

  • linkId: c17.2.20_help

Email

  • linkId: c17.2.21

Contact information for the site IRB contact.

  • linkId: c17.2_help

Study Coordinator Contact Information

  • linkId: c17.3

Study Coordinator Name

  • linkId: c17.3.1

Study Coordinator Institution or Organization

  • linkId: c17.3.8

Department Name or Division

  • linkId: c17.3.9

Street Address

  • linkId: c17.3.10

City

  • linkId: c17.3.11

State

  • linkId: c17.3.12

Zip Code

  • linkId: c17.3.13

Country

  • linkId: c17.3.14

Phone

  • linkId: c17.3.20

10-digit phone number, including area code

  • linkId: c17.3.20_help

Email

  • linkId: c17.3.21

Contact information for the study coordinator

  • linkId: c17.3_help

Site Principal Investigator Contact Information

  • linkId: c17.4

Site Principal Investigator Name

  • linkId: c17.4.1

Site Principal Investigator Institution

  • linkId: c17.4.8

Department Name or Division

  • linkId: c17.4.9

Street Address

  • linkId: c17.4.10

City

  • linkId: c17.4.11

State

  • linkId: c17.4.12

Zip Code

  • linkId: c17.4.13

Country

  • linkId: c17.4.14

Phone

  • linkId: c17.4.20

10-digit phone number, including area code

  • linkId: c17.4.20_help

Email

  • linkId: c17.4.21

Contact information for the PI. May be replicated from above.

  • linkId: c17.4_help

Participation

  • linkId: c18

Voluntary Permission Statement

  • linkId: c18.1
  • Initial Values: Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

Standard prepopulated statement, can be edited.

  • linkId: c18.1_help

What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.

  • linkId: c18.2

Anticipated circumstances under which subject's participation may be terminated by investigator without regard to subject's or legally authorized representative's consent

  • linkId: c18.2_help

Early Withdrawal

  • linkId: c19

Are there consequences to participant for early withdrawal?

Are there Emotional Consequences of Withdrawal

Are there Physical Consequences of Withdrawal

What are the consequences of withdrawal?

  • linkId: c19.4
  • Enable When: todo

Description of the withdrawal consequences, will depend and vary based on type of study.

  • linkId: c19.4_help

Confidentiality of Records

  • linkId: c20

Will HIPAA content be included within this document?

Medical information and billing statement

  • linkId: c20.2
  • Enable When: todo
  • Initial Values: Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.

If template information required for your state differs from text provided, reword to satisfy state requirements.

  • linkId: c20.2_help

Will confidentiality be protected?

Indicates if records identifying a subject will be maintained.

  • linkId: c20.3_help

How will confidentiality be protected?

  • linkId: c20.4
  • Enable When: todo

Explanation about processes and procedures to support maintaining privacy and confidentiality

  • linkId: c20.4_help

Are there data security or policies that need to be included in the consent, particularly around device use (optional)

Indicates if any data security policy applies to this consent, including device use.

  • linkId: c20.5_help

Describe any data security policies and processes protecting the data

  • linkId: c20.6
  • Enable When: todo

Optional field for capturing information on IT related data security policies. Example, use of encryption when utilizing mobile data collection

  • linkId: c20.6_help

Who can use or see participant information?

  • linkId: c20.7

Role or group who will have access to data

Description of Information Disclosed

  • linkId: c20.7.2

Will the data be released for future use?

Indicates whether these data will be used beyond the study window

  • linkId: c20.8_help

Will the future use data be deidentified?

Indicates if shared data will retain any identifiers.

  • linkId: c20.9_help

Deidentification detail

  • linkId: c20.10
  • Enable When: todo

Description of deidentification details for future use datasets.

  • linkId: c20.10_help

Required text disclosure surrounding future use.

Select the appropriate required text statement about disclosure surrounding future use of participant's data from the two standardized statements.

  • linkId: c20.11_help

Specimen Management

  • linkId: c21

Were specimens collected as part of this study?

Is whole genome sequencing being conducted?

Indicator of if genome sequencing is being conducted in conjunction with study

  • linkId: c21.2_help

Sharing or no Sharing of samples.

Indicator of whether biospecimens will be shared outside of the immediate study team or institution.

  • linkId: c21.3_help

Conditions of sharing

  • linkId: c21.4
  • Enable When: todo

Textual description of sharing conditions including, type, when, etc.

  • linkId: c21.4_help

Will participant share in profit with commerical use?

Indicator of any plans to profit share any funds received as a result of commercial use of those samples.

  • linkId: c21.5_help

Description of Collection and Storage

  • linkId: c21.6
  • Enable When: todo

Textual description of collection and storage procedures and policies for the study.

  • linkId: c21.6_help

Can consent for sample use be revoked?

Indicator of revocation of sample consent is an option

  • linkId: c21.7_help

Will there be Broad Consent for Storage, maintenance and secondary research use?

Statement of Broad Consent for Storage, maintenance and secondary research use

  • linkId: c22.1
  • Enable When: todo
  • Initial Values: Participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study. Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose.

Can the study team contact you for future research?

Conditions about contact for additional sample use, information not currently described or future research

  • linkId: c23.1
  • Enable When: todo

Description of the details for which the participant could be contacted

  • linkId: c23.1_help

Indicator if the participant contact information can be used for future questions or recuitment for this or other studies

  • linkId: c23_help

Will participants share in commercial profit?

Details about any profit sharing agreements or why profits will not be shared.

  • linkId: c24.1
  • Enable When: todo

Indicator of participants will receive any commercial profits resulting from their participation in study

  • linkId: c24_help

Will the study team contact you with new information that may affect your willingness to remain in the study

Indicator if study team will provide updates that may affect willingness to remain in study

  • linkId: c25_help

Will the study team disclose clinically relevant study results to you?

Condtions under which the study results will be disclosed to you

  • linkId: c26.1
  • Enable When: todo

Textual description of which results and when will be disclosed to you.

  • linkId: c26.1_help

Indicator of study team will provide results of lab tests or other feedback of results to you at any time.

  • linkId: c26_help

Clinical Trials.gov statement

  • linkId: c27
  • Initial Values: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Is this study covered under a Certificate of Confidentiality? (default Y in NIH)

Certificate of Confidentiality Statement

  • linkId: c28.1
  • Enable When: todo
  • Initial Values: The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc]

Indicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies)

  • linkId: c28.1_help

Required Disclosures based on state law

  • linkId: c28.2
  • Enable When: todo

Add any required text per your state laws.

  • linkId: c28.2_help

When will the PHI Authorization Expire based on date or time past an event

  • linkId: c29

PHI authorization expiration. Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure.

  • linkId: c29_help

Statement of PHI Authorization Revocation

  • linkId: c30
  • Initial Values: Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.

Signature

  • linkId: c31

Indicator to include Participant Signature and Date/Time

Indicator to include Assent Signature and Date/Time

Indicator to include Legally Authorized Representative Signature and Date/Time

Relationship of Legally Authorized Representative

Indicator to include a Witness Signature and Date/Time

Indicator to include Parent 1 Signature and Date/Time

Indicator to include Parent 2 Signature and Date/Time

Consent Version

  • linkId: c32

Consent Version Number

  • linkId: c32.1

sIRB Version Date of Consent

  • linkId: c32.2

Date that changes whenever a change is made to the consent. It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy.

  • linkId: c32.2_help

Relying Site Version Date of Consent

  • linkId: c32.3

A number that changes whenever a change is made to the consent. It is the versioning system of the relying institution, and is updated in accordance with the institution's policy.

  • linkId: c32.3_help

Expiration Date of Consent

  • linkId: c32.6

Other Attachments

  • linkId: c80

Describe the file that is being attached (optional)

  • linkId: c80.1

Attachment

  • linkId: c80.2

Other attachments that will be included in the Consent Form that will be provided to the participants should be included here.

  • linkId: c80_help

Administrative Use Only

  • Flags: icon
  • linkId: ADMIN00

Link ID prefix

  • Flags: icon
  • linkId: ADMIN01
  • Initial Values: c

Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any

  • Flags: icon
  • linkId: ADMIN02
  • Initial Values: temporarily unavailable

ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any

  • Flags: icon
  • linkId: ADMIN03
  • Initial Values: temporarily unavailable

Questionnaire Response ID of the local considerations Questionnaire Response, if any

  • Flags: icon
  • linkId: ADMIN04

Produced 06 Apr 2023