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-continuing-review-questionnaire-populate.html |
Url | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate |
Version | 1.0.0 |
Status | draft |
Date | 2023-04-24T20:03:27+00:00 |
Name | Continuing_review |
Title | Continuing Review |
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 |
---|---|---|---|---|---|
![]() ![]() | Questionnaire | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate#1.0.0 | |||
![]() ![]() ![]() | Research Study | 0..1 | group | ||
![]() ![]() ![]() ![]() | Study Title | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | Study Title from the Informed Consent | 0..1 | display | ||
![]() ![]() ![]() ![]() | IRB Protocol Number | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | Number assigned to the protocol by IRB | 0..1 | display | ||
![]() ![]() ![]() ![]() | Enrollment Status | 0..1 | choice | Options: 4 options | |
![]() ![]() ![]() ![]() | Intervention Status | 0..1 | choice | Options: 3 options | |
![]() ![]() ![]() ![]() ![]() | Current intervention status. This can be used by the IRB to determine that continuing review is no longer required. | 0..1 | display | ||
![]() ![]() ![]() ![]() | Study Status | 0..1 | choice | Options: 9 options | |
![]() ![]() ![]() ![]() ![]() | Status of the study overall. Study Status can also be used by the IRB to determine that continuing review is no longer required. | 0..1 | display | ||
![]() ![]() ![]() ![]() | Funding Source(check all that are applicable) | 0..* | choice | ![]() | Options: 7 options |
![]() ![]() ![]() ![]() ![]() | The funding source for the study. Note that a single study can have multiple funding sources and that the funding sources can change over time. | 0..1 | display | ||
![]() ![]() ![]() ![]() | Other Funding Source-Please specify: | 0..1 | string | Enable When: cr1.6 = Other Funding Source (Temporary Codes#otherfund) | |
![]() ![]() ![]() | sIRB (Reviewing Institution) | 0..1 | group | ||
![]() ![]() ![]() ![]() | sIRB (Reviewing Institution) Name | 0..1 | string | Expressions:
| |
![]() ![]() ![]() | Submission Type | 0..1 | group | ||
![]() ![]() ![]() ![]() | Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites? | 1..1 | choice | Options: 2 options | |
![]() ![]() ![]() ![]() ![]() | Select "Yes" if this Continuing Review Form is being completed by the lead principal investigator site, the study coordinating center or other administrative unit on behalf of all the relying sites in the overall study. | 0..1 | display | ||
![]() ![]() ![]() ![]() | External Data For linkId cr9.2 | 0..* | open-choice | ![]() | Expressions:
|
![]() ![]() ![]() ![]() | If this Continuing Review Form is specific to a relying site, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below. | 0..1 | choice | Enable When: cr9.1 = No (expandedYes-NoIndicator#N) | |
![]() ![]() ![]() ![]() ![]() | This question and its answer will not print on the Continuing Review 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 | ||
![]() ![]() ![]() | Site Principal Investigator Institution | 0..1 | group | ||
![]() ![]() ![]() ![]() | Site Principal Investigator Institution Name | 1..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() | Institution Department Name or Division | 0..1 | string | Expressions:
| |
![]() ![]() ![]() | Site Principal Investigator | 0..1 | group | ||
![]() ![]() ![]() ![]() | First Name | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | First or given name of the site principal investigator | 0..1 | display | ||
![]() ![]() ![]() ![]() | Last Name | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | Surname or family name | 0..1 | display | ||
![]() ![]() ![]() ![]() | Suffix | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display | ||
![]() ![]() ![]() ![]() | Degree(s) | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | Professional and Academic degrees of the site principal investigator | 0..1 | display | ||
![]() ![]() ![]() ![]() | Site Principal Investigator Department Name or Division | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() | Phone | 0..1 | string | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | 10-digit phone number, including area code | 0..1 | display | ||
![]() ![]() ![]() ![]() | 0..1 | string | Expressions:
| ||
![]() ![]() ![]() ![]() ![]() | Email address for site PI | 0..1 | display | ||
![]() ![]() ![]() | Report Type | 0..1 | group | ||
![]() ![]() ![]() ![]() | Is this an initial report? | 0..1 | choice | Options: 2 options | |
![]() ![]() ![]() ![]() ![]() | An initial report is the first time that the study is reviewed. | 0..1 | display | ||
![]() ![]() ![]() | Accrual of Participants | 0..1 | group | ||
![]() ![]() ![]() ![]() | The number of participants who are enrolled, approved to enroll, consented, withdrawn, lost to contact, screen failures, active or in follow-up, or completed study. | 0..1 | display | ||
![]() ![]() ![]() ![]() | Provide counts for the following | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() | If this is an initial review, provide counts since study inception. The count for the Previous Accrual should be entered as 0 when completing the questionnaire for the initial report. | 0..1 | display | Enable When: cr7.1 = Yes (expandedYes-NoIndicator#Y) | |
![]() ![]() ![]() ![]() ![]() | Participants enrolled since activation | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants enrolled since last approval | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants approved to enroll | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants consented | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants withdrawn | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants lost to contact | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants with screen failures | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants still active or follow-up | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | Participants completed study | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() | By Sex | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() | Men | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() ![]() | null | 0..1 | display | ||
![]() ![]() ![]() ![]() ![]() ![]() | Women | 0..1 | group | ||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Previous Accrual | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Additional enrollees this approval period | 0..1 | integer | ||
![]() ![]() ![]() ![]() ![]() ![]() ![]() | Total | 0..1 | integer | Expressions:
| |
![]() ![]() ![]() ![]() ![]() | null | 0..1 |