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

## 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:

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