4.3.2.324 CodeSystem http://hl7.org/fhir/research-study-status

Biomedical Research and Regulation Work Group

Maturity Level: 0

Trial Use

Use Context: Country: World

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This Code system is used in the following value sets:

• ValueSet: Research Study Status (Codes that convey the current status of the research study.)

4.3.2.324.1 Definition

Codes that convey the current status of the research study.

4.3.2.324.2 Content

This code system http://hl7.org/fhir/research-study-status defines the following codes:

Code	Display	Definition	Copy
overall-study	Overall study	Used for documenting the start and end of the overall study, distinct from progress states.
active	Active	Study is opened for accrual.
active-but-not-recruiting	Active, not recruiting	The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
administratively-completed	Administratively Completed	Study is completed prematurely and will not resume; patients are no longer examined nor treated.
approved	Approved	Protocol is approved by the review board.
closed-to-accrual	Closed to Accrual	Study is closed for accrual; patients can be examined and treated.
closed-to-accrual-and-intervention	Closed to Accrual and Intervention	Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study.
completed	Completed	The study closed according to the study plan. There will be no further treatments, interventions or data collection.
disapproved	Disapproved	Protocol was disapproved by the review board.
enrolling-by-invitation	Enrolling by invitation	The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
in-review	In Review	Protocol is submitted to the review board for approval.
not-yet-recruiting	Not yet recruiting	The study has not started recruiting participants.
recruiting	Recruiting	The study is currently recruiting participants.
temporarily-closed-to-accrual	Temporarily Closed to Accrual	Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated.
temporarily-closed-to-accrual-and-intervention	Temporarily Closed to Accrual and Intervention	Study is temporarily closed for accrual and intervention and potentially can be resumed in the future.
terminated	Terminated	The study has stopped early and will not start again. Participants are no longer being examined or treated.
withdrawn	Withdrawn	Protocol was withdrawn by the lead organization.

See the full registry of code systems defined as part of FHIR.

Explanation of the columns that may appear on this page: