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 |
sIRB | sIRB (Reviewing Site) | Site is the sIRB |
Relying | Relying Site | Site is the Relying Site |
VM | Telephone and 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-intvnt | 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 |
Other | Other | 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 |
continue-meds | Continuing interventions | TBD |