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 [...]
No. If the patient declines to watch the videos and would prefer to have you present the information to them verbally, that is their choice. However, for informed consent purposes, all the relevant information about the trial and participation in it must be presented to the patient. You can use the printed versions of the [...]
Be flexible when approaching a patient about participating in the study. Use the RA script as a guide, but do not feel like you have to adhere to it rigidly. Some patients may want to ask you questions first or hear you give a brief overview of the study before proceeding. To be prepared for [...]
The RA should note this ahead of time while pre-screening and arrange for a second, back-up recruiter to help with recruitment at that time. If a second recruiter is not available, approach one patient and record that the other was missed as discussed in the previous question.
If the physician completed a Clinic Screening Form (CSF) but the RA did not approach the patient about the study in clinic, record this in the Study Recruitment section (F) of the screening log. Then select “missed/skipped - RA unavailable” as the reason the patient was not approached, or “Other,” as appropriate. If other, please [...]
This scenario might occur at clinics that serve rural populations but is likely to be rare otherwise. Like the pending MRI cases discussed in C3, these patients can be consented and provisionally enrolled if they meet all eligibility criteria. Perform all of the usual enrollment procedures with the patient except for randomization. Follow up with [...]