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

CodeSystem: Temporary Codes

Summary

Defining URL:http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
Version:0.1.0
Name:TemporaryCodes
Title:Temporary Codes
Status:Draft as of 2021-07-23
Definition:

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

Publisher:HL7 International - BR&R Work Group
Content:Complete: All the concepts defined by the code system are included in the code system resource
Source Resource:XML / JSON / Turtle

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
sIRB sIRB (Reviewing Site)Site is the sIRB
Relying Relying SiteSite is the Relying Site
VM Telephone and 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-intvnt 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
Other OtherTBD
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
continue-meds Continuing interventionsTBD