Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## Questionnaire: Continuing Review Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate | Version: 1.0.0
Draft as of 2023-04-24 | Computable Name: Continuing_review

Structure

LinkId | Text | Cardinality | Type | Flags | Description & Constraints
--- | --- | --- | --- | --- | ---
Continuing_review |  |  | Questionnaire |  | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate#1.0.0
cr1 | Research Study | 0..1 | group |  |
cr1.1 | Study Title | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value`
cr1.1_help | Study Title from the Informed Consent | 0..1 | display |  |
cr1.2 | IRB Protocol Number | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value`
cr1.2_help | Number assigned to the protocol by IRB | 0..1 | display |  |
cr1.3 | Enrollment Status | 0..1 | choice |  | Options: 4 options
cr1.4 | Intervention Status | 0..1 | choice |  | Options: 3 options
cr1.4_help | Current intervention status. This can be used by the IRB to determine that continuing review is no longer required. | 0..1 | display |  |
cr1.5 | Study Status | 0..1 | choice |  | Options: 9 options
cr1.5_help | 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 |  |
cr1.6 | Funding Source(check all that are applicable) | 0..* | choice |  | Options: 7 options
cr1.6_help | 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 |  |
cr1.7 | Other Funding Source-Please specify: | 0..1 | string |  | Enable When: cr1.6 = Other Funding Source (Temporary Codes#otherfund)
cr12 | sIRB (Reviewing Institution) | 0..1 | group |  |
cr12.1 | sIRB (Reviewing Institution) Name | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value`
cr9 | Submission Type | 0..1 | group |  |
cr9.1 | 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
cr9.1_help | 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 |  |
ExternalDataFor_cr9.2 | External Data For linkId cr9.2 | 0..* | open-choice |  | Expressions: Initial Value: `%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value`
cr9.2 | 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)
cr9.2_help | 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 |  |
cr11 | Site Principal Investigator Institution | 0..1 | group |  |
cr11.1 | Site Principal Investigator Institution Name | 1..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)`
cr11.2 | Institution Department Name or Division | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.10').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value)`
cr2 | Site Principal Investigator | 0..1 | group |  |
cr2.1 | First Name | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)`
cr2.1_help | First or given name of the site principal investigator | 0..1 | display |  |
cr2.4 | Last Name | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)`
cr2.4_help | Surname or family name | 0..1 | display |  |
cr2.5 | Suffix | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)`
cr2.5_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
cr2.6 | Degree(s) | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)`
cr2.6_help | Professional and Academic degrees of the site principal investigator | 0..1 | display |  |
cr2.10 | Site Principal Investigator Department Name or Division | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.10').answer.value)`
cr2.2 | Phone | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)`
cr2.2_help | 10-digit phone number, including area code | 0..1 | display |  |
cr2.3 | Email | 0..1 | string |  | Expressions: Calculated Value: `iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)`
cr2.3_help | Email address for site PI | 0..1 | display |  |
cr7 | Report Type | 0..1 | group |  |
cr7.1 | Is this an initial report? | 0..1 | choice |  | Options: 2 options
cr7.1_help | An initial report is the first time that the study is reviewed. | 0..1 | display |  |
cr3 | Accrual of Participants | 0..1 | group |  |
cr3_help | 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 |  |
cr3.1 | Provide counts for the following | 0..1 | group |  |
cr3.1.15 | 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)
cr3.1.1 | Participants enrolled since activation | 0..1 | group |  |
cr3.1.1.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.1.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.1.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.1.1').answer.value + %resource.descendants().where(linkId = 'cr3.1.1.2').answer.value`
cr3.1.31 | null | 0..1 | display |  |
cr3.1.2 | Participants enrolled since last approval | 0..1 | group |  |
cr3.1.2.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.2.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.2.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.2.2').answer.value.toInteger()`
cr3.1.32 | null | 0..1 | display |  |
cr3.1.3 | Participants approved to enroll | 0..1 | group |  |
cr3.1.3.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.3.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.3.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.3.2').answer.value.toInteger()`
cr3.1.33 | null | 0..1 | display |  |
cr3.1.4 | Participants consented | 0..1 | group |  |
cr3.1.4.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.4.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.4.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.4.2').answer.value.toInteger()`
cr3.1.34 | null | 0..1 | display |  |
cr3.1.5 | Participants withdrawn | 0..1 | group |  |
cr3.1.5.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.5.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.5.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.5.2').answer.value.toInteger()`
cr3.1.35 | null | 0..1 | display |  |
cr3.1.6 | Participants lost to contact | 0..1 | group |  |
cr3.1.6.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.6.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.6.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.6.2').answer.value.toInteger()`
cr3.1.36 | null | 0..1 | display |  |
cr3.1.7 | Participants with screen failures | 0..1 | group |  |
cr3.1.7.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.7.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.7.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.7.2').answer.value.toInteger()`
cr3.1.37 | null | 0..1 | display |  |
cr3.1.8 | Participants still active or follow-up | 0..1 | group |  |
cr3.1.8.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.8.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.8.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.8.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.8.2').answer.value.toInteger()`
cr3.1.38 | null | 0..1 | display |  |
cr3.1.9 | Participants completed study | 0..1 | group |  |
cr3.1.9.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.9.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.9.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.9.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.9.2').answer.value.toInteger()`
cr3.1.39 | null | 0..1 | display |  |
cr3.1.10 | By Sex | 0..1 | group |  |
cr3.1.10.1 | Men | 0..1 | group |  |
cr3.1.10.1.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.10.1.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.10.1.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.10.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.1.2').answer.value.toInteger()`
cr3.1.10.31 | null | 0..1 | display |  |
cr3.1.10.2 | Women | 0..1 | group |  |
cr3.1.10.2.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.10.2.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.10.2.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.10.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.2.2').answer.value.toInteger()`
cr3.1.40 | null | 0..1 | display |  |
cr3.1.11 | By Race | 0..1 | group |  |
cr3.1.11.1 | White | 0..1 | group |  |
cr3.1.11.1.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.1.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.1.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.1.2').answer.value.toInteger()`
cr3.1.11.31 | null | 0..1 | display |  |
cr3.1.11.2 | Black or African American | 0..1 | group |  |
cr3.1.11.2.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.2.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.2.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.2.2').answer.value.toInteger()`
cr3.1.11.32 | null | 0..1 | display |  |
cr3.1.11.3 | Asian | 0..1 | group |  |
cr3.1.11.3.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.3.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.3.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.3.2').answer.value.toInteger()`
cr3.1.11.33 | null | 0..1 | display |  |
cr3.1.11.4 | American Indian or Alaska Native | 0..1 | group |  |
cr3.1.11.4.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.4.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.4.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.4.2').answer.value.toInteger()`
cr3.1.11.34 | null | 0..1 | display |  |
cr3.1.11.5 | Native Hawaiian or other Pacific Islander | 0..1 | group |  |
cr3.1.11.5.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.5.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.5.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.5.2').answer.value.toInteger()`
cr3.1.11.35 | null | 0..1 | display |  |
cr3.1.11.6 | More than One Race | 0..1 | group |  |
cr3.1.11.6.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.6.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.6.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.6.2').answer.value.toInteger()`
cr3.1.11.36 | null | 0..1 | display |  |
cr3.1.11.7 | Unknown/Not Reported | 0..1 | group |  |
cr3.1.11.7.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.11.7.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.11.7.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.11.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.7.2').answer.value.toInteger()`
cr3.1.41 | null | 0..1 | display |  |
cr3.1.12 | By Ethnicity | 0..1 | group |  |
cr3.1.12.1 | Hispanic or Latino | 0..1 | group |  |
cr3.1.12.1.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.12.1.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.12.1.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.12.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.1.2').answer.value.toInteger()`
cr3.1.12.31 | null | 0..1 | display |  |
cr3.1.12.2 | Not Hispanic or Latino | 0..1 | group |  |
cr3.1.12.2.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.12.2.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.12.2.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.12.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.2.2').answer.value.toInteger()`
cr3.1.12.32 | null | 0..1 | display |  |
cr3.1.12.3 | Unknown/Not Reported | 0..1 | group |  |
cr3.1.12.3.1 | Previous Accrual | 0..1 | integer |  |
cr3.1.12.3.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.1.12.3.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.1.12.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.3.2').answer.value.toInteger()`
cr3.1.42 | null | 0..1 | display |  |
cr3.1_help | Number of participants by category | 0..1 | display |  |
cr3.2 | Vulnerable Populations | 0..1 | group |  |
cr3.2.1 | Number of potentially vulnerable participants enrolled | 0..1 | group |  |
cr3.2.1.1 | Previous Accrual | 0..1 | integer |  |
cr3.2.1.2 | Additional enrollees this approval period | 0..1 | integer |  |
cr3.2.1.3 | Total | 0..1 | integer |  | Expressions: Calculated Value: `%resource.descendants().where(linkId = 'cr3.2.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.2.1.2').answer.value.toInteger()`
cr3.2.30 | null | 0..1 | display |  |
cr3.2.2 | Check the applicable checkboxes if these groups are represented in the columns above | 0..1 | group |  |
cr3.2.2.15 | For an initial report, skip the checkboxes for Previous Accrual | 0..1 | display |  | Enable When: cr7.1 = Yes (expandedYes-NoIndicator#Y)
cr3.2.2.1 | Children | 0..* | choice |  | Options: 2 options
cr3.2.2.2 | Cognitively Impaired | 0..* | choice |  | Options: 2 options
cr3.2.2.3 | Employees | 0..* | choice |  | Options: 2 options
cr3.2.2.4 | Fetuses | 0..* | choice |  | Options: 2 options
cr3.2.2.5 | Neonates (non-viable / uncertain viability) | 0..* | choice |  | Options: 2 options
cr3.2.2.6 | Pregnant Women | 0..* | choice |  | Options: 2 options
cr3.2.2.7 | Prisoners | 0..* | choice |  | Options: 2 options
cr3.2.2.8 | Students | 0..* | choice |  | Options: 2 options
cr3.2.2.9 | Other | 0..* | choice |  | Options: 2 options
cr3.2.2.10 | Please describe other vulnerable participants enrolled, if any: | 0..1 | text |  | Enable When: cr3.2.2.9 = Previous Accrual (Temporary Codes#PreviousAccrual) cr3.2.2.9 = Additional enrollees this approval period (Temporary Codes#AdditionalEnrollees)
cr3.2_help | Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. (CIOMS) | 0..1 | display |  |
cr4 | Study Report | 0..1 | group |  |
cr4.5 | Since your last report: | 0..1 | group |  |
cr4.5.50 | (since the study inception for an initial report) | 0..1 | display |  | Enable When: cr7.1 = Yes (expandedYes-NoIndicator#Y)
cr4.5.1 | Summarize the study progress | 0..1 | text |  |
cr4.5.1_help | Summary of activities in the study (since the last report if this is not an initial review) | 0..1 | display |  |
cr4.5.2 | Have participants experienced any benefits? | 0..1 | choice |  | Options: 2 options
cr4.5.2_help | Indicator of benefits to participants | 0..1 | display |  |
cr4.5.3 | If yes, please summarize the benefits: | 0..1 | text |  | Enable When: cr4.5.2 = Yes (expandedYes-NoIndicator#Y)
cr4.5.4 | Have participants been withdrawn from this study? | 0..1 | choice |  | Options: 2 options
cr4.5.5 | If yes, please summarize the withdrawals: | 0..1 | text |  | Enable When: cr4.5.4 = Yes (expandedYes-NoIndicator#Y)
cr4.5.6 | Have any participants or others complained about the research? | 0..1 | choice |  | Options: 2 options
cr4.5.7 | If yes, please summarize the complaints: | 0..1 | text |  | Enable When: cr4.5.6 = Yes (expandedYes-NoIndicator#Y)
cr4.5.8 | Has any new and relevant literature been published related to the risks or benefits associated with this research? | 0..1 | choice |  | Options: 2 options
cr4.5.8_help | literature published related to the risks or benefits associated with this research | 0..1 | display |  |
cr4.5.9 | If yes, please summarize relevance to study: | 0..1 | text |  | Enable When: cr4.5.8 = Yes (expandedYes-NoIndicator#Y)
cr4.5.10 | Have there been any interim findings? | 0..1 | choice |  | Options: 2 options
cr4.5.11 | If yes, please summarize findings: | 0..1 | text |  | Enable When: cr4.5.10 = Yes (expandedYes-NoIndicator#Y)
cr4.5.12 | Have there been any multi-center trial reports? | 0..1 | choice |  | Options: 2 options
cr4.5.13 | If yes, please summarize findings and recommendations | 0..1 | text |  | Enable When: cr4.5.12 = Yes (expandedYes-NoIndicator#Y)
cr4.5.14 | Have there been any data safety monitoring board reports? | 0..1 | choice |  | Options: 2 options
cr4.5.15 | If yes, please summarize findings and recommendations: | 0..1 | text |  | Enable When: cr4.5.14 = Yes (expandedYes-NoIndicator#Y)
cr4.5.16 | In the opinion of the Principal Investigator, have the risks or potential benefits changed? | 0..1 | choice |  | Options: 2 options
cr4.5.17 | If yes, please summarize the changes: | 0..1 | text |  | Enable When: cr4.5.16 = Yes (expandedYes-NoIndicator#Y)
cr4.5.18 | Has an audit of the research been conducted by a federal agency or sponsor? | 0..1 | choice |  | Options: 2 options
cr4.5.19 | Have there been any presentations or publications (including abstracts) from this research? | 0..1 | choice |  | Options: 2 options
cr4.5.20 | Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment? | 0..1 | choice |  | Options: 2 options
cr4.5.21 | If yes, please summarize the changes: | 0..1 | text |  | Enable When: cr4.5.20 = Yes (expandedYes-NoIndicator#Y)
cr4.5.22 | Was informed consent obtained from all enrolled participants? | 0..1 | choice |  | Options: 2 options
cr4.5.23 | Has there been any other relevant information regarding this protocol? | 0..1 | choice |  | Options: 2 options
cr4.5.24 | If yes, please summarize: | 0..1 | text |  | Enable When: cr4.5.23 = Yes (expandedYes-NoIndicator#Y)
cr5 | Adverse Events | 0..1 | group |  |
cr5_help | Any adverse events (medical and/or non-medical) during the previous continuing review period (or since the study inception for an initial report) | 0..1 | display |  |
cr5.1 | Have there been any internal or local adverse events in the research? | 0..1 | choice |  | Options: 2 options
cr5.2 | Did these adverse events occur at the frequency and level of severity expected? | 0..1 | choice |  | Enable When: cr5.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options
cr5.12 | If no, please explain: | 0..1 | text |  | Enable When: cr5.2 = No (expandedYes-NoIndicator#N)
cr5.3 | Have any protocol deviations or violations occurred in this study? | 0..1 | choice |  | Options: 2 options
cr5.13 | If yes, please describe the protocol deviations or violations | 0..1 | text |  | Enable When: cr5.3 = Yes (expandedYes-NoIndicator#Y)
cr6 | Conflict of Interest | 0..1 | group |  |
cr6.1 | Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB? | 0..1 | choice |  | Options: 2 options
cr6.2 | If yes, please explain: | 0..1 | text |  | Enable When: cr6.1 = Yes (expandedYes-NoIndicator#Y)
cr17 | Attachments | 0..* | group |  |
cr17.1 | Describe the file that is being attached (optional) | 0..1 | string |  |
cr17.2 | Attachment | 0..1 | attachment |  |
cr17_help | Attachments related to the Continuing Review can be included here. Examples are a DSMB report or an Adverse Event Report (Medical or Non-Medical). | 0..1 | display |  |
ADMIN00 | Administrative Use Only | 0..1 | group |  |
ADMIN01 | Link ID prefix | 0..1 | string |  | Initial Value: string = cr
ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | 0..1 | string |  | Initial Value: string = temporarily unavailable Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value`
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any | 0..1 | string |  | Initial Value: string = temporarily unavailable Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value`
ADMIN04 | Questionnaire Response ID of the local considerations Questionnaire Response, if any | 0..1 | string |  |
Documentation for this format

Option Sets

Answer options for cr1.3

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#not-open ("Not yet open")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#open-no-participants ("Open with no participants")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#open ("Open for enrollment")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#closed ("Closed to enrollment")

Answer options for cr1.4

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#complete ("All interventions complete")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#continue-meds ("Continuing interventions")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#continue-min-risk ("Continuing interventions - minimal risk")

Answer options for cr1.5

- http://hl7.org/fhir/research-study-status#active ("Active")
- http://hl7.org/fhir/research-study-status#disapproved ("Disapproved")
- http://hl7.org/fhir/research-study-status#closed-to-accrual ("Closed to Accrual")
- http://hl7.org/fhir/research-study-status#closed-to-accrual-and-intervention ("Closed to Accrual and Intervention")
- http://hl7.org/fhir/research-study-status#completed ("Completed")
- http://hl7.org/fhir/research-study-status#administratively-completed ("Administratively Completed")
- http://hl7.org/fhir/research-study-status#temporarily-closed-to-accrual ("Temporarily Closed to Accrual")
- http://hl7.org/fhir/research-study-status#temporarily-closed-to-accrual-and-intervention ("Temporarily Closed to Accrual and Intervention")
- http://hl7.org/fhir/research-study-status#withdrawn ("Withdrawn")

Answer options for cr1.6

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#federal ("Federal")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#state ("State")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#industry ("Industry")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#foundation ("Foundation")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#institutional ("Institutional")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#departmental ("Departmental")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#otherfund ("Other Funding Source")

Answer options for cr9.1

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr7.1

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr3.2.2.1

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.2

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.3

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.4

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.5

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.6

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.7

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.8

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr3.2.2.9

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PreviousAccrual ("Previous Accrual")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AdditionalEnrollees ("Additional enrollees this approval period")

Answer options for cr4.5.2

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.4

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.6

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.8

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.10

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.12

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.14

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.16

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.18

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.19

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.20

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.22

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr4.5.23

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr5.1

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr5.2

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr5.3

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for cr6.1

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")