Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, 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 2023-04-20 Computable Name: Continuing_review
Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. Continuing_reviewQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate#1.0.0
... cr1Research Study0..1group
.... cr1.1Study Title0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
..... cr1.1_helpStudy Title from the Informed Consent0..1display
.... cr1.2IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
..... cr1.2_helpNumber assigned to the protocol by IRB0..1display
.... cr1.3Enrollment Status0..1choiceOptions: 4 options
.... cr1.4Intervention Status0..1choiceOptions: 3 options
..... cr1.4_helpCurrent intervention status. This can be used by the IRB to determine that continuing review is no longer required.0..1display
.... cr1.5Study Status0..1choiceOptions: 9 options
..... cr1.5_helpStatus of the study overall. Study Status can also be used by the IRB to determine that continuing review is no longer required.0..1display
.... cr1.6Funding Source(check all that are applicable)0..*choiceiconOptions: 7 options
..... cr1.6_helpThe 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..1display
.... cr1.7Other Funding Source-Please specify:0..1stringEnable When: cr1.6 = Other Funding Source (Temporary Codes#otherfund)
... cr12sIRB (Reviewing Institution)0..1group
.... cr12.1sIRB (Reviewing Institution) Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
... cr9Submission Type0..1group
.... cr9.1Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?1..1choiceOptions: 2 options
..... cr9.1_helpSelect "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..1display
.... ExternalDataFor_cr9.2External Data For linkId cr9.20..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
.... cr9.2If 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..1choiceEnable When: cr9.1 = No (expandedYes-NoIndicator#N)
..... cr9.2_helpThis 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..1display
... cr11Site Principal Investigator Institution0..1group
.... cr11.1Site Principal Investigator Institution Name1..1stringExpressions:
  • 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)
.... cr11.2Institution Department Name or Division0..1stringExpressions:
  • 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)
... cr2Site Principal Investigator0..1group
.... cr2.1First Name0..1stringExpressions:
  • 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_helpFirst or given name of the site principal investigator0..1display
.... cr2.4Last Name0..1stringExpressions:
  • 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_helpSurname or family name0..1display
.... cr2.5Suffix0..1stringExpressions:
  • 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_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
.... cr2.6Degree(s)0..1stringExpressions:
  • 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_helpProfessional and Academic degrees of the site principal investigator0..1display
.... cr2.10Site Principal Investigator Department Name or Division0..1stringExpressions:
  • 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)
.... cr2.2Phone0..1stringExpressions:
  • 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_help10-digit phone number, including area code0..1display
.... cr2.3Email0..1stringExpressions:
  • 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_helpEmail address for site PI0..1display
... cr7Report Type0..1group
.... cr7.1Is this an initial report?0..1choiceOptions: 2 options
..... cr7.1_helpAn initial report is the first time that the study is reviewed.0..1display
... cr3Accrual of Participants0..1group
.... cr3_helpThe 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..1display
.... cr3.1Provide counts for the following0..1group
..... cr3.1.15If 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..1displayEnable When: cr7.1 = Yes (expandedYes-NoIndicator#Y)
..... cr3.1.1Participants enrolled since activation0..1group
...... cr3.1.1.1Previous Accrual0..1integer
...... cr3.1.1.2Additional enrollees this approval period0..1integer
...... cr3.1.1.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.1.1').answer.value + %resource.descendants().where(linkId = 'cr3.1.1.2').answer.value
..... cr3.1.31null0..1display
..... cr3.1.2Participants enrolled since last approval0..1group
...... cr3.1.2.1Previous Accrual0..1integer
...... cr3.1.2.2Additional enrollees this approval period0..1integer
...... cr3.1.2.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.2.2').answer.value.toInteger()
..... cr3.1.32null0..1display
..... cr3.1.3Participants approved to enroll0..1group
...... cr3.1.3.1Previous Accrual0..1integer
...... cr3.1.3.2Additional enrollees this approval period0..1integer
...... cr3.1.3.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.3.2').answer.value.toInteger()
..... cr3.1.33null0..1display
..... cr3.1.4Participants consented0..1group
...... cr3.1.4.1Previous Accrual0..1integer
...... cr3.1.4.2Additional enrollees this approval period0..1integer
...... cr3.1.4.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.4.2').answer.value.toInteger()
..... cr3.1.34null0..1display
..... cr3.1.5Participants withdrawn0..1group
...... cr3.1.5.1Previous Accrual0..1integer
...... cr3.1.5.2Additional enrollees this approval period0..1integer
...... cr3.1.5.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.5.2').answer.value.toInteger()
..... cr3.1.35null0..1display
..... cr3.1.6Participants lost to contact0..1group
...... cr3.1.6.1Previous Accrual0..1integer
...... cr3.1.6.2Additional enrollees this approval period0..1integer
...... cr3.1.6.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.6.2').answer.value.toInteger()
..... cr3.1.36null0..1display
..... cr3.1.7Participants with screen failures0..1group
...... cr3.1.7.1Previous Accrual0..1integer
...... cr3.1.7.2Additional enrollees this approval period0..1integer
...... cr3.1.7.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.7.2').answer.value.toInteger()
..... cr3.1.37null0..1display
..... cr3.1.8Participants still active or follow-up0..1group
...... cr3.1.8.1Previous Accrual0..1integer
...... cr3.1.8.2Additional enrollees this approval period0..1integer
...... cr3.1.8.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.8.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.8.2').answer.value.toInteger()
..... cr3.1.38null0..1display
..... cr3.1.9Participants completed study0..1group
...... cr3.1.9.1Previous Accrual0..1integer
...... cr3.1.9.2Additional enrollees this approval period0..1integer
...... cr3.1.9.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.1.9.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.9.2').answer.value.toInteger()
..... cr3.1.39null0..1display
..... cr3.1.10By Sex0..1group
...... cr3.1.10.1Men0..1group
....... cr3.1.10.1.1Previous Accrual0..1integer
....... cr3.1.10.1.2Additional enrollees this approval period0..1integer
....... cr3.1.10.1.3Total0..1integerExpressions:
  • 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()
...... cr3.1.10.31null0..1display
...... cr3.1.10.2Women0..1group
....... cr3.1.10.2.1Previous Accrual0..1integer
....... cr3.1.10.2.2Additional enrollees this approval period0..1integer
....... cr3.1.10.2.3Total0..1integerExpressions:
  • 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()
..... cr3.1.40null0..1display
..... cr3.1.11By Race0..1group
...... cr3.1.11.1White0..1group
....... cr3.1.11.1.1Previous Accrual0..1integer
....... cr3.1.11.1.2Additional enrollees this approval period0..1integer
....... cr3.1.11.1.3Total0..1integerExpressions:
  • 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()
...... cr3.1.11.31null0..1display
...... cr3.1.11.2Black or African American0..1group
....... cr3.1.11.2.1Previous Accrual0..1integer
....... cr3.1.11.2.2Additional enrollees this approval period0..1integer
....... cr3.1.11.2.3Total0..1integerExpressions:
  • 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()
...... cr3.1.11.32null0..1display
...... cr3.1.11.3Asian0..1group
....... cr3.1.11.3.1Previous Accrual0..1integer
....... cr3.1.11.3.2Additional enrollees this approval period0..1integer
....... cr3.1.11.3.3Total0..1integerExpressions:
  • 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()
...... cr3.1.11.33null0..1display
...... cr3.1.11.4American Indian or Alaska Native0..1group
....... cr3.1.11.4.1Previous Accrual0..1integer
....... cr3.1.11.4.2Additional enrollees this approval period0..1integer
....... cr3.1.11.4.3Total0..1integerExpressions:
  • 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()
...... cr3.1.11.34null0..1display
...... cr3.1.11.5Native Hawaiian or other Pacific Islander0..1group
....... cr3.1.11.5.1Previous Accrual0..1integer
....... cr3.1.11.5.2Additional enrollees this approval period0..1integer
....... cr3.1.11.5.3Total0..1integerExpressions:
  • 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()
...... cr3.1.11.35null0..1display
...... cr3.1.11.6More than One Race0..1group
....... cr3.1.11.6.1Previous Accrual0..1integer
....... cr3.1.11.6.2Additional enrollees this approval period0..1integer
....... cr3.1.11.6.3Total0..1integerExpressions:
  • 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()
...... cr3.1.11.36null0..1display
...... cr3.1.11.7Unknown/Not Reported0..1group
....... cr3.1.11.7.1Previous Accrual0..1integer
....... cr3.1.11.7.2Additional enrollees this approval period0..1integer
....... cr3.1.11.7.3Total0..1integerExpressions:
  • 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()
..... cr3.1.41null0..1display
..... cr3.1.12By Ethnicity0..1group
...... cr3.1.12.1Hispanic or Latino0..1group
....... cr3.1.12.1.1Previous Accrual0..1integer
....... cr3.1.12.1.2Additional enrollees this approval period0..1integer
....... cr3.1.12.1.3Total0..1integerExpressions:
  • 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()
...... cr3.1.12.31null0..1display
...... cr3.1.12.2Not Hispanic or Latino0..1group
....... cr3.1.12.2.1Previous Accrual0..1integer
....... cr3.1.12.2.2Additional enrollees this approval period0..1integer
....... cr3.1.12.2.3Total0..1integerExpressions:
  • 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()
...... cr3.1.12.32null0..1display
...... cr3.1.12.3Unknown/Not Reported0..1group
....... cr3.1.12.3.1Previous Accrual0..1integer
....... cr3.1.12.3.2Additional enrollees this approval period0..1integer
....... cr3.1.12.3.3Total0..1integerExpressions:
  • 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()
..... cr3.1.42null0..1display
..... cr3.1_helpNumber of participants by category0..1display
.... cr3.2Vulnerable Populations0..1group
..... cr3.2.1Number of potentially vulnerable participants enrolled0..1group
...... cr3.2.1.1Previous Accrual0..1integer
...... cr3.2.1.2Additional enrollees this approval period0..1integer
...... cr3.2.1.3Total0..1integerExpressions:
  • Calculated Value: %resource.descendants().where(linkId = 'cr3.2.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.2.1.2').answer.value.toInteger()
..... cr3.2.30null0..1display
..... cr3.2.2Check the applicable checkboxes if these groups are represented in the columns above0..1group
...... cr3.2.2.15For an initial report, skip the checkboxes for Previous Accrual0..1displayEnable When: cr7.1 = Yes (expandedYes-NoIndicator#Y)
...... cr3.2.2.1Children0..*choiceiconOptions: 2 options
...... cr3.2.2.2Cognitively Impaired0..*choiceiconOptions: 2 options
...... cr3.2.2.3Employees0..*choiceiconOptions: 2 options
...... cr3.2.2.4Fetuses0..*choiceiconOptions: 2 options
...... cr3.2.2.5Neonates (non-viable / uncertain viability)0..*choiceiconOptions: 2 options
...... cr3.2.2.6Pregnant Women0..*choiceiconOptions: 2 options
...... cr3.2.2.7Prisoners0..*choiceiconOptions: 2 options
...... cr3.2.2.8Students0..*choiceiconOptions: 2 options
...... cr3.2.2.9Other0..*choiceiconOptions: 2 options
...... cr3.2.2.10Please describe other vulnerable participants enrolled, if any:0..1textEnable When:
  • cr3.2.2.9 = Previous Accrual (Temporary Codes#PreviousAccrual)
  • cr3.2.2.9 = Additional enrollees this approval period (Temporary Codes#AdditionalEnrollees)
..... cr3.2_helpVulnerable 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..1display
... cr4Study Report0..1group
.... cr4.5Since your last report:0..1group
..... cr4.5.50(since the study inception for an initial report)0..1displayEnable When: cr7.1 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.1Summarize the study progress0..1text
...... cr4.5.1_helpSummary of activities in the study (since the last report if this is not an initial review)0..1display
..... cr4.5.2Have participants experienced any benefits?0..1choiceOptions: 2 options
...... cr4.5.2_helpIndicator of benefits to participants0..1display
..... cr4.5.3If yes, please summarize the benefits:0..1textEnable When: cr4.5.2 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.4Have participants been withdrawn from this study?0..1choiceOptions: 2 options
..... cr4.5.5If yes, please summarize the withdrawals:0..1textEnable When: cr4.5.4 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.6Have any participants or others complained about the research?0..1choiceOptions: 2 options
..... cr4.5.7If yes, please summarize the complaints:0..1textEnable When: cr4.5.6 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.8Has any new and relevant literature been published related to the risks or benefits associated with this research?0..1choiceOptions: 2 options
...... cr4.5.8_helpliterature published related to the risks or benefits associated with this research0..1display
..... cr4.5.9If yes, please summarize relevance to study:0..1textEnable When: cr4.5.8 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.10Have there been any interim findings?0..1choiceOptions: 2 options
..... cr4.5.11If yes, please summarize findings:0..1textEnable When: cr4.5.10 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.12Have there been any multi-center trial reports?0..1choiceOptions: 2 options
..... cr4.5.13If yes, please summarize findings and recommendations0..1textEnable When: cr4.5.12 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.14Have there been any data safety monitoring board reports?0..1choiceOptions: 2 options
..... cr4.5.15If yes, please summarize findings and recommendations:0..1textEnable When: cr4.5.14 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.16In the opinion of the Principal Investigator, have the risks or potential benefits changed?0..1choiceOptions: 2 options
..... cr4.5.17If yes, please summarize the changes:0..1textEnable When: cr4.5.16 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.18Has an audit of the research been conducted by a federal agency or sponsor?0..1choiceOptions: 2 options
..... cr4.5.19Have there been any presentations or publications (including abstracts) from this research?0..1choiceOptions: 2 options
..... cr4.5.20Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?0..1choiceOptions: 2 options
..... cr4.5.21If yes, please summarize the changes:0..1textEnable When: cr4.5.20 = Yes (expandedYes-NoIndicator#Y)
..... cr4.5.22Was informed consent obtained from all enrolled participants?0..1choiceOptions: 2 options
..... cr4.5.23Has there been any other relevant information regarding this protocol?0..1choiceOptions: 2 options
..... cr4.5.24If yes, please summarize:0..1textEnable When: cr4.5.23 = Yes (expandedYes-NoIndicator#Y)
... cr5Adverse Events0..1group
.... cr5_helpAny adverse events (medical and/or non-medical) during the previous continuing review period (or since the study inception for an initial report)0..1display
.... cr5.1Have there been any internal or local adverse events in the research?0..1choiceOptions: 2 options
.... cr5.2Did these adverse events occur at the frequency and level of severity expected?0..1choiceEnable When: cr5.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
.... cr5.12If no, please explain:0..1textEnable When: cr5.2 = No (expandedYes-NoIndicator#N)
.... cr5.3Have any protocol deviations or violations occurred in this study?0..1choiceOptions: 2 options
.... cr5.13If yes, please describe the protocol deviations or violations0..1textEnable When: cr5.3 = Yes (expandedYes-NoIndicator#Y)
... cr6Conflict of Interest0..1group
.... cr6.1Has 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..1choiceOptions: 2 options
.... cr6.2If yes, please explain:0..1textEnable When: cr6.1 = Yes (expandedYes-NoIndicator#Y)
... cr17Attachments0..*group
.... cr17.1Describe the file that is being attached (optional)0..1string
.... cr17.2Attachment0..1attachment
.... cr17_helpAttachments related to the Continuing Review can be included here. Examples are a DSMB report or an Adverse Event Report (Medical or Non-Medical).0..1display
... ADMIN00Administrative Use Only0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = cr
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1stringicon

doco 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")