What source documents should be created as part of the enrollment process?

ALL of the following forms should be completed during screening/enrollment: Clinic Screening Form (CRF-00) – completed by the physician Informed Consent Document (ICD) – signed & dated by both the patient and the person obtaining consent (give signed copy to the patient) PT Medical Info Release Form – signed by the patient (give copy to [...]

How do I enroll a patient in the study?

Once consented, a record for the patient should be created in the Subject database. This is done by completing and saving the patient’s screening log record and then clicking the +Enroll button that appears at the top left. This will create a corresponding record in the Subject database for that patient that is linked to [...]

When can/should a patient be enrolled in the study?

Patients must be consented before they can be enrolled in the study. Patients should only be consented and enrolled in the study if they meet ONE of following conditions: (1) The patient has had an MRI and meets all eligibility criteria (2) An MRI has been ordered AND the patient will not return to clinic [...]

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