Code | Display | Definition |
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active | Active | Study is opened for accrual. |
administratively-completed | Administratively Completed | Study is completed prematurely and will not resume; patients are no longer examined nor treated.
Tagged. |
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 | 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. |
disapproved | Disapproved | Protocol was disapproved by the review board. |
in-review | In Review | Protocol is submitted to the review board for approval. |
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. |
withdrawn | Withdrawn | Protocol was withdrawn by the lead organization. |
Code | Display | Definition |
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candidate | Candidate | An identified person that can be considered for inclusion in a study. |
eligible | Eligible | A person that has met the eligibility criteria for inclusion in a study. |
follow-up | Follow-up | A person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule. |
ineligible | Ineligible | A person who did not meet one or more criteria required for participation in a study is considered to have failed screening or
is ineligible for the study. |
not-registered | Not Registered | A person for whom registration was not completed. |
off-study | Off-study | A person that has ended their participation on a study either because their treatment/observation is complete or through not
responding, withdrawal, non-compliance and/or adverse event. |
on-study | On-study | A person that is enrolled or registered on a study. |
on-study-intervention | On-study-intervention | The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating. |
on-study-observation | On-study-observation | The subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is "short-term follow-up". |
pending-on-study | Pending on-study | A person is pre-registered for a study. |
potential-candidate | Potential Candidate | A person that is potentially eligible for participation in the study. |
screening | Screening | A person who is being evaluated for eligibility for a study. |
withdrawn | Withdrawn | The person has withdrawn their participation in the study before registration. |
Code | Display | Definition |
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treatment | Treatment | One or more interventions are being evaluated for treating a disease, syndrome, or condition. |
prevention | Prevention | One or more interventions are being assessed for preventing the development of a specific disease or health condition. |
diagnostic | Diagnostic | One or more interventions are being evaluated for identifying a disease or health condition. |
supportive-care | Supportive Care | One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function. |
screening | Screening | One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor. |
health-services-research | Health Services Research | One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare. |
basic-science | Basic Science | One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention). |
device-feasibility | Device Feasibility | An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. |
Code | Display | Definition |
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n-a | N/A | Trials without phases (for example, studies of devices or behavioral interventions). |
early-phase-1 | Early Phase 1 | Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0. |
phase-1 | Phase 1 | Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. |
phase-1-phase-2 | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
phase-2 | Phase 2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. |
phase-2-phase-3 | Phase 2/Phase 3 | Trials that are a combination of phases 2 and 3. |
phase-3 | Phase 3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. |
phase-4 | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |