Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example Questionnaire: Continuing Review Questionnaire

The Continuing Review Questionnaire collects data used in a report which is then provided to the sIRB on a regular basis so that continued activity on the study can be reviewed.

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. Continuing_reviewQuestionnaire
... cr1Research Study0..1group
.... cr1.1Study Title0..1string
..... cr1.1_helpStudy Title from the Informed Consent0..1display
.... cr1.2IRB Protocol Number0..1string
..... cr1.2_helpNumber assigned to the protocol by IRB0..1display
.... cr1.3Enrollment Status:0..1choiceOptions: 4 options
.... cr1.4Intervention Status:0..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 Status:0..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..*open-choiceOptions: 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
..... cr1.6.1Other-Please specify:0..1textEnable When:
... cr2Site Principal Investigator0..1group
.... cr2.1First Name0..1string
..... cr2.1_helpFirst or given name associated with the site principal investigator0..1display
.... cr2.4Last Name0..1string
..... cr2.4_helpSurname or family name associated with the site principal investigator0..1display
.... cr2.5Suffix0..1string
..... cr2.5_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name0..1display
.... cr2.6Degree(s)0..1string
..... cr2.6_helpProfessional and Academic degrees associated with the site principal investigator0..1display
.... cr2.2Phone0..1string
.... cr2.3Email:0..1string
... cr3aReport Type0..1group
.... cr3a.1Is this an initial report?0..1choiceOptions: 2 options
..... cr3a.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, are screen failures, are active or in follow-up , or completed study0..1display
.... cr3.1Provide counts for the following:0..1group
..... cr3.1_helpHow many participants there are in each category0..1display
..... cr3.1.1Participants enrolled since activation:0..1integer
..... cr3.1.2Participants enrolled since last approval (or since study inception if initial review):0..1integer
..... cr3.1.3Participants approved to enroll:0..1integer
..... cr3.1.4Participants consented:0..1integer
..... cr3.1.5Participants withdrawn:0..1integer
..... cr3.1.6Participants lost to contact:0..1integer
..... cr3.1.7Participants with screen failures:0..1integer
..... cr3.1.8Participants still active or follow-up:0..1integer
..... cr3.1.9Participants completed study:0..1integer
..... cr3.1.10By Sex:0..1group
...... cr3.1.10.1Men:0..1integer
...... cr3.1.10.2Women:0..1integer
..... cr3.1.11By Race0..1group
...... cr3.1.11.1White:0..1integer
...... cr3.1.11.2Black or African American:0..1integer
...... cr3.1.11.3Asian:0..1integer
...... cr3.1.11.4American Indian or Alaska Native:0..1integer
...... cr3.1.11.5Native Hawaiian or other Pacific Islander:0..1integer
...... cr3.1.11.6More than One Race:0..1integer
...... cr3.1.11.7Unknown/Not Reported:0..1integer
..... cr3.1.12By Ethnicity0..1group
...... cr3.1.12.1Hispanic or Latino:0..1integer
...... cr3.1.12.2Not Hispanic or Latino:0..1integer
...... cr3.1.12.3Unknown/Not Reported:0..1integer
.... cr3.2Vulnerable Populations0..1group
..... cr3.2.1Number of potentially vulnerable participants enrolled:0..1integer
..... cr3.2.2Check all that apply:0..1group
...... cr3.2.2.1Children0..1boolean
...... cr3.2.2.2Cognitively Impaired0..1boolean
...... cr3.2.2.3Employees0..1boolean
...... cr3.2.2.4Fetuses0..1boolean
...... cr3.2.2.5Neonates (non-viable / uncertain viability)0..1boolean
...... cr3.2.2.6Pregnant Women0..1boolean
...... cr3.2.2.7Prisoners0..1boolean
...... cr3.2.2.8Students0..1boolean
..... 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 (or since the study inception for an initial report):0..1group
..... cr4.5.1Summarize the study progress:0..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:
..... cr4.5.4Have participants been withdrawn from this study?0..1choiceOptions: 2 options
..... cr4.5.5If yes, please summarize the withdrawals:0..1textEnable When:
..... 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:
..... cr4.5.8Has 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:
..... cr4.5.10Have there been any interim findings?0..1choiceOptions: 2 options
..... cr4.5.11If yes, please summarize findings:0..1textEnable When:
..... 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:
..... cr4.5.14Have there been any data safety monitoring board reports?0..1choiceOptions: 2 options
..... cr4.5.15If yes, please summarize findings and recommendations:0..1textEnable When:
..... cr4.5.16In 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:
..... cr4.5.18Has 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:
..... cr4.5.22Was 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:
... cr5Adverse Events0..1group
.... cr5_helpSummary of adverse events 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:
Options: 2 options
.... cr5.3Have any protocol deviations or violations occurred in this study?0..1choiceOptions: 2 options
... 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:
... ADMIN00Administrative Use Only0..1group
.... ADMIN01Link ID prefix0..1stringInitial Value: string = cr
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringInitial Value: string = temporarily unavailable
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any0..1stringInitial Value: string = temporarily unavailable
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1string

doco Documentation for this format

Option Sets

Answer options for cr1.3

Answer options for cr1.4

Answer options for cr1.5

Answer options for cr1.6

Answer options for cr3a.1

Answer options for cr4.5.2

Answer options for cr4.5.4

Answer options for cr4.5.6

Answer options for cr4.5.8

Answer options for cr4.5.10

Answer options for cr4.5.12

Answer options for cr4.5.14

Answer options for cr4.5.16

Answer options for cr4.5.18

Answer options for cr4.5.19

Answer options for cr4.5.20

Answer options for cr4.5.22

Answer options for cr4.5.23

Answer options for cr5.1

Answer options for cr5.2

Answer options for cr5.3

Answer options for cr6.1