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

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

CodeSystem: Temporary Codes (Experimental)

Official URL: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes Version: 1.0.0
Draft as of 2021-07-23 Computable Name: TemporaryCodes
Other Identifiers: id: temporary-codes

This is a temporary codesystem capturing the custom codelists used across the sIRB forms.

This Code system is referenced in the content logical definition of the following value sets:

This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This code system http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes defines the following codes:

CodeDisplayDefinition
INITIAL InitialTBD
UPDATE UpdateTBD
INT InterventionalTBD
OBS ObservationalTBD
APPROVED Approved for relianceTBD
POSSIBLE Potential/possibleTBD
CANCELLED Cancelled or not participatingTBD
ONHOLD Temporarily on holdTBD
DENIED Denied relianceTBD
SFS Sponsor or Funding SourceTBD
CRO Contract Research Organization (CRO)TBD
AR Accepts ReviewTBD
DR Denies ReviewTBD
PHONECALL Telephone callsTBD
VM Voice mail and telephone voice messagesTBD
VC Video ConferencingTBD
EMAIL EmailTBD
TXT Text messages/textingTBD
EHPRTL eHealth Portal messagingTBD
SA Study AgentTBD
PLACEBO PlaceboTBD
BSA Blinded Study AgentTBD
PRMYDIS Primary diseaseTBD
STDYPRO Study ProcedureTBD
PRE Pre-existing conditionTBD
UNDERLYINGDIS Underlying diseaseTBD
CONCMITMED Concomitant medicationTBD
OTHERCAUSE Other known or suspected causeTBD
nochange No change in research activitiesTBD
stopped All research activities temporarily and voluntarily stopped for all participantsTBD
partial Partial voluntary hold on some research activities for all participants (explain below)TBD
hold Voluntary hold on new participant enrollment onlyTBD
init InitialTBD
followup Follow-upTBD
completed Done, performed or completedThe action was done, performed or completed
pending Pending - Currently under developmentThe action is in progress or status is pending
notundertaken Not done or undertakenThe action was not started and is not in progress
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)TBD
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 participantsTBD
otherreason Other reasonTBD
open Open for enrollmentTBD
closed Closed to enrollmentTBD
not-open Not yet openTBD
open-no-participants Open with no participantsTBD
complete All interventions completeTBD
continue-meds Continuing interventionsTBD
continue-min-risk Continuing interventions - minimal riskTBD
federal FederalTBD
state StateTBD
industry IndustryTBD
foundation FoundationTBD
institutional InstitutionalTBD
departmental DepartmentalTBD
otherfund Other Funding SourceTBD
DBV Drug/Biologic/VaccineTBD
DEV DeviceTBD
SBE Social/Behavioral/educational (SBE)TBD
PRO ProceduralTBD
IND INDTBD
IDE IDETBD
COPI Co-Principal InvestigatorTBD
COI Co-InvestigatorTBD
PD Program DirectorTBD
RES ResearchTBD
STDCR Standard of CareTBD
PHYS PhysicalTBD
NONPHYS Non-PhysicalTBD
TRTNOTCOV Treatment not coveredTBD
RRICOV Research Related injury coveredTBD
ACNOTCICOV Acute but not chronic injury coveredTBD
OTHINSTRES Researchers at other institutionsTBD
THISINSTRES Researchers outside the study team at this institutionTBD
EXTREGAUTH External Regulatory AuthoritiesTBD
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.TBD
DEIDNOTUSED Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.TBD
sourceQuestionnaireResponse The content of the Questionnaire Response transferred to this Questionnaire during form launchThe content of the Questionnaire Response transferred to this Questionnaire during form launch
ResultsInDeath Results in deathResults in death
IsLifeThreatening Is Life-threateningIs Life-threatening
ResultsInHospitalization Requires or prolongs inpatient hospitalizationRequires or prolongs inpatient hospitalization
IsBirthDefect Is a congenital anomaly/birth defectIs a congenital anomaly/birth defect
ResultsInDisability Results in persistent or significant disability/incapacityResults in persistent or significant disability/incapacity
RequiresPreventImpairment Requires intervention to prevent permanent impairmentRequires intervention to prevent permanent impairment
Other OtherTBD
RCVRED Recovered/ResolvedRecovered/Resolved
RCVRING Recovering/ResolvingRecovering/Resolving
NRCVRED Not recovered/Not resolved/OngoingNot recovered/Not resolved/Ongoing
SEQL Recovered/Resolved with sequelaeRecovered/Resolved with sequelae
FATAL FatalFatal
UNK UnknownUnknown
NC Product dose or frequency of use not changedProduct dose or frequency of use not changed
NA Not applicableNot applicable
PreviousAccrual Previous AccrualPrevious Accrual
AdditionalEnrollees Additional enrollees this approval periodAdditional enrollees this approval period