You should track when the patient’s MRI is scheduled and confer with the physician to determine if the patient meets the remaining MRI & post-MRI criteria and finish filling out the CSF accordingly. If the patient meets all eligibility criteria, then they should be randomized when they are called with their MRI results. The RA [...]
No. Under certain circumstances (see D1 above) the patient may provide consent and be provisionally enrolled in the study prior to receiving their MRI results, but they should not be randomized until the tear has been confirmed on an MRI.
No, enrollment & randomization will be based on the treating MD’s read of the MRI. The study radiologist will later review the MRI to verify the presence of a tear and its size. If the size is different than that indicated by the MD, but still within the range of eligibility for the trial, the [...]
A patient should only be randomized if ALL of the following conditions obtain: (1) the patient meets all eligibility requirements, (2) the tear size, as seen on MRI, is greater than 0 and less than or equal to 4cm (as determined by the treating physician), (3) the patient has provided informed consent and confirmed willingness [...]
It is the job of the study recruiter to make sure each patient (a) meets eligibility criteria, and (b) fully understands and freely consents to the terms of participation in the study. Beyond that it is up to the patient to decide whether or not to participate in the study. You should not try to [...]
The last section of the Baseline Questionnaire that asks about treatment preference should ALWAYS be reviewed prior to randomizing a patient. If the patient indicates a strong preference for one treatment over the other, or there is a significant difference in how successful the patient believes each of the two treatments will be, take a [...]
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 [...]
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 [...]
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 [...]
Patients enrolled in the study need to be able to begin their assigned treatment within 2 months (8 weeks). Since treatment assignment is randomized, there is no way to know in advance which treatment arm a patient will be assigned to for the trial. If a patient’s insurance company will not pay for surgery, they [...]