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Book Index

Patient status

A list of patient statuses appears in the Patient Status section on the Dashboard along with the number of patients with each status. The statuses track the patient through the enrollment process. The Patient Status section also includes the number of Active patients (total number of patients minus patients with a Completed or Discontinued status).

The following statuses are standard with the OutcomeLogix application. Study designers can create additional, study-specific statuses. A patient can have only one status at a time.

Patient status descriptions

Status

Description

Prescreened

Patient has been created but not enrolled.

Created

Patient details were submitted. The first visit with an expected date is created for the patient.

Withdrawn

Patient withdrew from the study or declined the ICD form. The trigger for this status is study-specific.

Consented

Patient signed the ICD.

Screening

Patient completed the EDC and ePRO forms required for screening. The patient met all the inclusion criteria and none of the exclusion criteria.

Screen-Failed

Patient started the screening process and then failed for one or more reasons; for example, the patient selected No on the Site Inclusion form and, therefore, cannot be included in the study.

Opt Out

Patient declined to sign the ICD.

Enrolled

Patient completed the EDC and ePRO forms required for enrollment.

Randomized

Patient was randomized in the study.

Discontinued

Patient was enrolled, but was discontinued for one or more reasons.

Lost to follow-up

Patient was enrolled in the study but never returned or cannot be contacted after repeated efforts. The trigger for this status is study-specific.

Completed

Patient completed the last protocol-specified event (visit, web, or telephone contact).

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