Single Institutional Review Board (sIRB) Implementation Guide
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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

Descriptions of CodeSystems

Usage of Codesystems from HL7 CodeSystems Registry in the sIRB Questionnaires


Where possible, the sIRB Questionnaires use the values in the HL7 CodeSystems Registry1 at https://terminology.hl7.org/3.0.0/codesystems.html. For some questions, not all values in a given codesystem were applicable to the sIRB use case and only a subset of the values were included as answer options for those questions.

The Codesystems from HL7 CodeSystems Registry that were used in the sIRB Questionnaires are:

CodeSystem Official URL Questionnaire(s) Using this CodeSystem
expandedYes-NoIndicator http://terminology.hl7.org/CodeSystem/v2-0532 Initiate a Study Questionnaire, Protocol Questionnaire, Consent Questionnaire, Recruitment Materials Questionnaire, Continuing Review Questionnaire, Adverse Medical Event Questionnaire and Adverse Non-Medical Event Questionnaire
ResearchStudyPhase http://terminology.hl7.org/CodeSystem/research-study-phase Protocol Questionnaire
Unified Code for Units of Measure (UCUM)2 http://unitsofmeasure.org Consent Questionnaire
relationship http://terminology.hl7.org/CodeSystem/v2-0063 Consent Questionnaire
ResearchStudyStatus http://hl7.org/fhir/research-study-status Continuing Review Questionnaire
administrativeSex http://terminology.hl7.org/CodeSystem/v2-0001 Adverse Medical Event Questionnaire
Ethnicity http://terminology.hl7.org/CodeSystem/v3-Ethnicity Adverse Medical Event Questionnaire
Race http://terminology.hl7.org/CodeSystem/v3-Race Adverse Medical Event Questionnaire
AdverseEventSeriousness http://terminology.hl7.org/CodeSystem/adverse-event-seriousness Adverse Medical Event Questionnaire
AdverseEventSeverity http://terminology.hl7.org/CodeSystem/adverse-event-severity Adverse Medical Event Questionnaire
AdverseEventCausalityAssessment http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess Adverse Medical Event Questionnaire
actionTakenInResponseToTheEvent http://terminology.hl7.org/CodeSystem/v2-0251 Adverse Medical Event Questionnaire



sIRB-specific Codesystem in the sIRB Questionnaires


In many cases, the values and concepts in the sIRB Questionnaires were not yet captured by an existing HL7 Codesystem or the existing Codesystems did not contain all of the values needed. In these circumstances, we have created our own codes for the sIRB Questionnaires. We have included these in the siRB IG at CodeSystem-temporarycodes.html, which is represented as a codeSystem resource.

Because of the low maturity level of the sIRB IG, a temporary code list within the IG was used. As the sIRB Questionnaires mature, the codes within the sIRB Questionnaires will grow in maturity and we foresee that we will work with the HL7 terminology workgroup to have officially registered CodeSystems created and listed in the HL7 CodeSystems Registry.

Below are the descriptions of the sIRB temporary codes:

Topic Code Display Questionnaire(s) Using this Codesystem
Adverse Event Submission Type INITIAL Initial Adverse Medical Event Questionnaire
Adverse Event Submission Type UPDATE Update Adverse Medical Event Questionnaire
       
Study Type INT Interventional Initiate a Study Questionnaire, Protocol Questionnaire and Adverse Medical Event Questionnaire
Study Type OBS Observational Initiate a Study Questionnaire, Protocol Questionnaire and Adverse Medical Event Questionnaire
       
Status of reliance APPROVED Approved for reliance Initiate a Study Questionnaire
Status of reliance POSSIBLE Potential/possible Initiate a Study Questionnaire
Status of reliance CANCELLED Cancelled or not participating Initiate a Study Questionnaire
Status of reliance ONHOLD Temporarily on hold Initiate a Study Questionnaire
Status of reliance DENIED Denied reliance Initiate a Study Questionnaire
       
Professional Relationship Type SFS Sponsor or Funding Source Initiate a Study Questionnaire
Professional Relationship Type CRO Contract Research Organization (CRO) Initiate a Study Questionnaire
       
Determination Decision AR Accepts Review Determination Letter Questionnaire
Determination Decision DR Denies Review Determination Letter Questionnaire
       
Types of communication methods that will be used to reply to potential participants PHONECALL Telephone calls Recruitment Materials Questionnaire
Types of communication methods that will be used to reply to potential participants VM Voice mail and telephone voice messages Recruitment Materials Questionnaire
Types of communication methods that will be used to reply to potential participants VC Video Conferencing Recruitment Materials Questionnaire
Types of communication methods that will be used to reply to potential participants EMAIL Email Recruitment Materials Questionnaire
Types of communication methods that will be used to reply to potential participants TXT Text messages/texting Recruitment Materials Questionnaire
Types of communication methods that will be used to reply to potential participants EHPRTL eHealth Portal messaging Recruitment Materials Questionnaire
       
Type of study agent received SA Study Agent Adverse Medical Event Questionnaire
Type of study agent received PLACEBO Placebo Adverse Medical Event Questionnaire
Type of study agent received BSA Blinded Study Agent Adverse Medical Event Questionnaire
       
Possible alternate causes of the SAE PRMYDIS Primary disease Adverse Medical Event Questionnaire
Possible alternate causes of the SAE STDYPRO Study Procedure Adverse Medical Event Questionnaire
Possible alternate causes of the SAE PRE Pre-existing condition Adverse Medical Event Questionnaire
Possible alternate causes of the SAE UNDERLYINGDIS Underlying disease Adverse Medical Event Questionnaire
Possible alternate causes of the SAE CONCMITMED Concomitant medication Adverse Medical Event Questionnaire
Possible alternate causes of the SAE OTHERCAUSE Other known or suspected cause Adverse Medical Event Questionnaire
       
Status of study research activities nochange No change in research activities Adverse Non-Medical Event Questionnaire
Status of study research activities stopped All research activities temporarily and voluntarily stopped for all participants Adverse Non-Medical Event Questionnaire
Status of study research activities partial Partial voluntary hold on some research activities for all participants (explain below) Adverse Non-Medical Event Questionnaire
Status of study research activities hold Voluntary hold on new participant enrollment only Adverse Non-Medical Event Questionnaire
       
Adverse Non-Medical Event Report Status init Initial Adverse Non-Medical Event Questionnaire
Adverse Non-Medical Event Report Status followup Follow-up Adverse Non-Medical Event Questionnaire
       
Status of Risk Reduction Activities completed Done, performed or completed Adverse Non-Medical Event Questionnaire
Status of Risk Reduction Activities pending Pending - Currently under development Adverse Non-Medical Event Questionnaire
Status of Risk Reduction Activities notundertaken Not done or undertaken Adverse Non-Medical Event Questionnaire
       
Exception Types for Protocol and Consent Changes after Adverse Non-Medical Event mla Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants) Adverse Non-Medical Event Questionnaire
Exception Types for Protocol and Consent Changes after Adverse Non-Medical Event mtd Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants Adverse Non-Medical Event Questionnaire
Exception Types for Protocol and Consent Changes after Adverse Non-Medical Event otherreason Other reason Adverse Non-Medical Event Questionnaire
       
Study Enrollment Status open Open for enrollment Continuing Review Questionnaire
Study Enrollment Status closed Closed to enrollment Continuing Review Questionnaire
Study Enrollment Status not-open Not yet open Continuing Review Questionnaire
Study Enrollment Status open-no-participants Open with no participants Continuing Review Questionnaire
       
Study Intervention Status complete All interventions complete Continuing Review Questionnaire
Study Intervention Status continue-meds Continuing interventions Continuing Review Questionnaire
Study Intervention Status continue-min-risk Continuing interventions - minimal risk Continuing Review Questionnaire
       
Study Funding Source federal Federal Continuing Review Questionnaire
Study Funding Source state State Continuing Review Questionnaire
Study Funding Source industry Industry Continuing Review Questionnaire
Study Funding Source foundation Foundation Continuing Review Questionnaire
Study Funding Source institutional Institutional Continuing Review Questionnaire
Study Funding Source departmental Departmental Continuing Review Questionnaire
Study Funding Source otherfund Other Funding Source Continuing Review Questionnaire
       
Intervention Type DBV Drug/Biologic/Vaccine Protocol Questionnaire
Intervention Type DEV Device Protocol Questionnaire
Intervention Type SBE Social/Behavioral/educational (SBE) Protocol Questionnaire
Intervention Type PRO Procedural Protocol Questionnaire
       
Type of FDA exemption IND IND Initiate a Study Questionnaire, Protocol Questionnaire and Adverse Medical Event Questionnaire
Type of FDA exemption IDE IDE Initiate a Study Questionnaire, Protocol Questionnaire and Adverse Medical Event Questionnaire
       
Additional Investigator Role COPI Co-Principal Investigator Protocol Questionnaire
Additional Investigator Role COI Co-Investigator Protocol Questionnaire
Additional Investigator Role PD Program Director Protocol Questionnaire
       
Research Indicator RES Research Consent Questionnaire
Research Indicator STDCR Standard of Care Consent Questionnaire
       
Risk Category PHYS Physical Consent Questionnaire
Risk Category NONPHYS Non-Physical Consent Questionnaire
       
Coverage for medical treatment from research related injury TRTNOTCOV Treatment not covered Consent Questionnaire
Coverage for medical treatment from research related injury RRICOV Research Related injury covered Consent Questionnaire
Coverage for medical treatment from research related injury ACNOTCICOV Acute but not chronic injury covered Consent Questionnaire
       
Role or group who will have access to data OTHINSTRES Researchers at other institutions Consent Questionnaire
Role or group who will have access to data THISINSTRES Researchers outside the study team at this institution Consent Questionnaire
Role or group who will have access to data EXTREGAUTH External Regulatory Authorities Consent Questionnaire
       
Deidentification detail DEIDUSED Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent. Consent Questionnaire
Deidentification detail DEIDNOTUSED Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified. Consent Questionnaire
       
launchContext name code sourceQuestionnaireResponse The content of the Questionnaire Response transferred to this Questionnaire during form launch Protocol Questionnaire, Consent Questionnaire, Determination Letter Questionnaire, Recruitment Materials Questionnaire, Adverse Medical Event Questionnaire, Adverse Non-Medical Event Questionnaire and Continuing Review Questionnaire
       
Justification for Adverse Event Classification as Serious ResultsInDeath3 Results in death Adverse Medical Event Questionnaire
Justification for Adverse Event Classification as Serious IsLifeThreatening3 Is Life-threatening Adverse Medical Event Questionnaire
Justification for Adverse Event Classification as Serious ResultsInHospitalization3 Requires or prolongs inpatient hospitalization Adverse Medical Event Questionnaire
Justification for Adverse Event Classification as Serious IsBirthDefect3 Is a congenital anomaly/birth defect Adverse Medical Event Questionnaire
Justification for Adverse Event Classification as Serious ResultsInDisability3 Results in persistent or significant disability/incapacity Adverse Medical Event Questionnaire
Justification for Adverse Event Classification as Serious RequiresPreventImpairment4 Requires intervention to prevent permanent impairment Adverse Medical Event Questionnaire
Justification for Adverse Event Classification as Serious Other3 Other Adverse Medical Event Questionnaire
       
Outcome of Adverse Medical Event RCVRED5 Recovered/Resolved Adverse Medical Event Questionnaire
Outcome of Adverse Medical Event RCVRING5 Recovering/Resolving Adverse Medical Event Questionnaire
Outcome of Adverse Medical Event NRCVRED5 Not recovered/Not resolved/Ongoing Adverse Medical Event Questionnaire
Outcome of Adverse Medical Event SEQL5 Recovered/Resolved with sequelae Adverse Medical Event Questionnaire
Outcome of Adverse Medical Event FATAL5 Fatal Adverse Medical Event Questionnaire
Outcome of Adverse Medical Event UNK5 Unknown Adverse Medical Event Questionnaire
       
Other Actions Taken Regarding Study Intervention in Response to Adverse Event NC6 Product dose or frequency of use not changed Adverse Medical Event Questionnaire
Other Actions Taken Regarding Study Intervention in Response to Adverse Event NA6 Not applicable Adverse Medical Event Questionnaire
Other Actions Taken Regarding Study Intervention in Response to Adverse Event UNK6 Unknown Adverse Medical Event Questionnaire
       
Participant Accrual Type PreviousAccrual Previous Accrual Continuing Review Questionnaire
Participant Accrual Type AdditionalEnrollees Additional enrollees this approval period Continuing Review Questionnaire


Example ResearchStudy resource (optional)


In the example, the research study category of C98388 Interventional Study from the NCI Metathesaurus7 codesystem is shown. This codesystem is not meant to imply that this codesystem is the required or suggested codesystem to use in the ResearchStudy category element in the sIRB utililization of the ResearchStudy resource.


1 HL7 CodeSystems Registry. Content is copyright HL7. Licensed under creative commons public domain.

2 The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse.

3 Based on the Boolean data elements for ICSR E.i.3.2 Seriousness Criteria at Event Level in the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data Elements and Message Specification, Version 5.02, 10 November 2016 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Copyright International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that the ICH's copyright is acknowledged at all times.

4 The value "Requires intervention to prevent permanent impairment" is from What is a Serious Adverse Event? at https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event, which is in the public domain.

5 Based on the values in ICSR E.i.7 Outcome of Reaction / Event at the Time of Last Observation in the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data Elements and Message Specification, Version 5.02, 10 November 2016 by ICH. Copyright ICH. May be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that the ICH's copyright is acknowledged at all times.

6 These codes are additional values needed to broaden the existing HL7 Codesystem actionTakenInResponseToTheEvent to represent all of values in the ICSR Implementation Guide. ICSR G.k.8 Action(s) Taken with Drug in the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data Elements and Message Specification, Version 5.02, 10 November 2016 by ICH. Copyright ICH. May be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that the ICH's copyright is acknowledged at all times.

7 NCI Metathesaurus at http://ncimeta.nci.nih.gov is in the public domain. For more details about the NCI Metathesaurus, see Using the NCI Metathesaurus with FHIR.