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")
The content of the Questionnaire Response transferred to this Questionnaire during form launch
The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire
variable to store the incoming data from the launchContext extension for populate and other expressions
submission type (overall study or site-specific)
%resource.descendants().where(linkId = 'cr9.1').answer.valueCoding.code
site that this Continuing Review form pertains to
%resource.descendants().where(linkId = 'cr9.2').answer.valueCoding.display
HL7 International - Biomedical Research and Regulation
%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
Current intervention status. This can be used by the IRB to determine that continuing review is no longer required.
Temporarily Closed to Accrual and Intervention
Status of the study overall. Study Status can also be used by the IRB to determine that continuing review is no longer required.
Funding Source(check all that are applicable)
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.
%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?
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.
%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression).
%resource.repeat(item).where(linkId = 'ExternalDataFor_cr9.2').answer.value
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.
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.
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)
Site Principal Investigator Institution Name
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)
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)
First or given name of the site principal investigator
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)
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)
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
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)
Professional and Academic degrees of the site principal investigator
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)
Site Principal Investigator Department Name or Division
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)
10-digit phone number, including area code
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)
An initial report is the first time that the study is reviewed.
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.
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.
color:#5caf42; font-size: 115%; font-weight:bold
color:#425caf; font-size: 115%; font-weight:bold
Additional enrollees this approval period
%resource.descendants().where(linkId = 'cr3.1.1.1').answer.value + %resource.descendants().where(linkId = 'cr3.1.1.2').answer.value
Participants enrolled since last approval
%resource.descendants().where(linkId = 'cr3.1.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.2.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.3.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.4.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.5.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.6.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.7.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.8.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.8.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.9.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.9.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.10.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.1.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.10.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.2.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.11.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.1.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.11.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.2.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.11.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.3.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.11.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.4.2').answer.value.toInteger()
Native Hawaiian or other Pacific Islander
%resource.descendants().where(linkId = 'cr3.1.11.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.5.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.11.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.6.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.11.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.7.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.12.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.1.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.12.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.2.2').answer.value.toInteger()
%resource.descendants().where(linkId = 'cr3.1.12.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.3.2').answer.value.toInteger()
Number of potentially vulnerable participants enrolled
%resource.descendants().where(linkId = 'cr3.2.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.2.1.2').answer.value.toInteger()
Check the applicable checkboxes if these groups are represented in the columns above
For an initial report, skip the checkboxes for Previous Accrual
Neonates (non-viable / uncertain viability)
Please describe other vulnerable participants enrolled, if any:
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)
(since the study inception for an initial report)
Summary of activities in the study (since the last report if this is not an initial review)
Have participants experienced any benefits?
Have participants been withdrawn from this study?
If yes, please summarize the withdrawals:
Have any participants or others complained about the research?
If yes, please summarize the complaints:
Has any new and relevant literature been published related to the risks or benefits associated with this research?
literature published related to the risks or benefits associated with this research
If yes, please summarize relevance to study:
Have there been any multi-center trial reports?
If yes, please summarize findings and recommendations
Have there been any data safety monitoring board reports?
If yes, please summarize findings and recommendations:
In the opinion of the Principal Investigator, have the risks or potential benefits changed?
Has an audit of the research been conducted by a federal agency or sponsor?
Have there been any presentations or publications (including abstracts) from this research?
Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?
Was informed consent obtained from all enrolled participants?
Has there been any other relevant information regarding this protocol?
Any adverse events (medical and/or non-medical) during the previous continuing review period (or since the study inception for an initial report)
Have there been any internal or local adverse events in the research?
Did these adverse events occur at the frequency and level of severity expected?
Have any protocol deviations or violations occurred in this study?
If yes, please describe the protocol deviations or violations
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?
Describe the file that is being attached (optional)
Attachments related to the Continuing Review can be included here. Examples are a DSMB report or an Adverse Event Report (Medical or Non-Medical).
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any
Questionnaire Response ID of the local considerations Questionnaire Response, if any