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

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

## 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 Metathesaurus 7 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.

### Copyright/Legal Notes for Codesystems

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.