Code | Display | Definition | Deprecated |
adverseEvent | adverse event | adverse event. | |
death | death (adverse event) | death (adverse event). | |
notEligible | did not meet eligibility criteria | did not meet eligibility criteria. | |
eligibleButNo | eligible but unwilling or unable to participate | eligible but unwilling or unable to participate. | |
enrolled | enrolled or registered | enrolled or registered. | |
exclusion | exclusion | exclusion. | |
followUpComplete | follow-up complete | follow-up complete. | |
inclusion | inclusion | inclusion. | |
informedConsentSigned | Informed consent signed | Informed consent signed. | Deprecated |
intOrObsComplete | intervention or observation complete | intervention or observation complete. | Deprecated |
nonCompliance | non-compliance | non-compliance. | |
preReg | pre-registered or slot reserved | pre-registered or slot reserved. | |
refuseConsent | refuse consent | refuse consent. | |
screenFailure | screen failure | screen failure. | |
studyClosed | study permanently closed to accrual | study permanently closed to accrual. | |
studyTerminated | study terminated | study terminated. | |
subjectRefusal | subject refusal | subject refusal. | |
unwillingOrUnable | unwilling or unable to participate | unwilling or unable to participate. | |
withdrawnConsent | withdrawn consent | withdrawn consent. | |
unable-to-participate | Unable to Participate | The subject (ResearchSubject) is not able to take part in the ResearchStudy. Examples: subject has moved away; subject cannot drive and therefore unable to participate, etc. | |
unwilling-to-participate | Unwilling to Participate | The subject (ResearchSubject) is refusing to take part in the ResearchStudy. Note: Subject refusal is a synonymous term and is used in some studies. | |
screening-failure | Screening Failure | The failure of the potential subject (ResearchSubject) of meeting one or more criteria required for participation in a trial. | |
intervention-complete | Intervention Complete | The subject (ResearchSubject) has finished the planned protocol-specified treatment phase. | |
follow-up-complete | Follow-up Complete | The subject (ResearchSubject) has finished the planned protocol-specified follow-up phase. | |
adverse-event | Adverse Event | The subject (ResearchSubject) has experienced any unfavorable or unintended disease, sign, or symptom that is temporally associated with the use of a medical treatment or procedure and that may or may not be considered related to the medical treatment or procedure. | |
consent-withdrawn | Consent Withdrawn | The subject (ResearchSubject) has revoked permission to participate in the study or one or more components of the study. | |
non-compliance | Non-compliance | The subject (ResearchSubject) has failed to follow medical advice, take medication as directed, or adhere to a prescribed course of treatment. | |