CodeSystem Comparison between http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes vs http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes

Messages

Metadata

Name	Value		Comments
caseSensitive	true
compositional
content	complete
copyright
date	2021-07-23
description	This is a temporary codesystem capturing the custom codelists used across the sIRB forms.
experimental	true
hierarchyMeaning
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#US
name	TemporaryCodes
publisher	HL7 International - BR&R Work Group
purpose
status	draft
title	Temporary Codes
url	http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
version	0.1.0	1.0.0	Values Differ
versionNeeded

Concepts

Code	Display		Comments
INITIAL	Initial
UPDATE	Update
INT	Interventional
OBS	Observational
APPROVED	Approved for reliance
POSSIBLE	Potential/possible
CANCELLED	Cancelled or not participating
ONHOLD	Temporarily on hold
DENIED	Denied reliance
SFS	Sponsor or Funding Source
CRO	Contract Research Organization (CRO)
AR	Accepts Review
DR	Denies Review
sIRB	sIRB (Reviewing Site)		Removed this concept
Relying	Relying Site		Removed this concept
VM	Telephone and voice messages	Voice mail and telephone voice messages	display changed from left to right
VC	Video Conferencing
EMAIL	Email
TXT	Text messages/texting
EHPRTL	eHealth Portal messaging
SA	Study Agent
PLACEBO	Placebo
BSA	Blinded Study Agent
PRMYDIS	Primary disease
STDYPRO	Study Procedure
PRE	Pre-existing condition
UNDERLYINGDIS	Underlying disease
CONCMITMED	Concomitant medication
OTHERCAUSE	Other known or suspected cause
nochange	No change in research activities
stopped	All research activities temporarily and voluntarily stopped for all participants
partial	Partial voluntary hold on some research activities for all participants (explain below)
hold	Voluntary hold on new participant enrollment only
init	Initial
followup	Follow-up
completed	Done, performed or completed
pending	Pending - Currently under development
notundertaken	Not done or undertaken
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)
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
otherreason	Other reason
open	Open for enrollment
closed	Closed to enrollment
not-open	Not yet open
open-no-participants	Open with no participants
complete	All interventions complete
continue-intvnt	Continuing interventions		Removed this concept
continue-min-risk	Continuing interventions - minimal risk
federal	Federal
state	State
industry	Industry
foundation	Foundation
institutional	Institutional
departmental	Departmental
otherfund	Other Funding Source
Other	Other
DBV	Drug/Biologic/Vaccine
DEV	Device
SBE	Social/Behavioral/educational (SBE)
PRO	Procedural
IND	IND
IDE	IDE
COPI	Co-Principal Investigator
COI	Co-Investigator
PD	Program Director
RES	Research
STDCR	Standard of Care
PHYS	Physical
NONPHYS	Non-Physical
TRTNOTCOV	Treatment not covered
RRICOV	Research Related injury covered
ACNOTCICOV	Acute but not chronic injury covered
OTHINSTRES	Researchers at other institutions
THISINSTRES	Researchers outside the study team at this institution
EXTREGAUTH	External Regulatory Authorities
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.
DEIDNOTUSED	Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.
continue-meds	Continuing interventions
PHONECALL		Telephone calls	Added this concept
sourceQuestionnaireResponse		The content of the Questionnaire Response transferred to this Questionnaire during form launch	Added this concept
ResultsInDeath		Results in death	Added this concept
IsLifeThreatening		Is Life-threatening	Added this concept
ResultsInHospitalization		Requires or prolongs inpatient hospitalization	Added this concept
IsBirthDefect		Is a congenital anomaly/birth defect	Added this concept
ResultsInDisability		Results in persistent or significant disability/incapacity	Added this concept
RequiresPreventImpairment		Requires intervention to prevent permanent impairment	Added this concept
RCVRED		Recovered/Resolved	Added this concept
RCVRING		Recovering/Resolving	Added this concept
NRCVRED		Not recovered/Not resolved/Ongoing	Added this concept
SEQL		Recovered/Resolved with sequelae	Added this concept
FATAL		Fatal	Added this concept
UNK		Unknown	Added this concept
NC		Product dose or frequency of use not changed	Added this concept
NA		Not applicable	Added this concept
PreviousAccrual		Previous Accrual	Added this concept
AdditionalEnrollees		Additional enrollees this approval period	Added this concept