How to change a patient's status in a clinical trial?

Within the system, patients are assigned statuses.

1. When assigning a patient to a study, the system will automatically assign them to the status: Screening, because this patient has not yet followed the path in accordance with the clinical trial protocol.

2. Select: "status" to view the status history of the patient

You will see information when and by whom the patient was added - because this is the first activity in the study for this patient.

3. After registering and completing the screening visit (as part of EDM after completing the forms, without EDM by selecting the "end" visit option), you will be given the opportunity to update the status.

You can choose: screening (if not all screening procedures have been completed, screen failure (if the patient is not eligible for further participation in the study) or Run-In (if the patient goes to the next stage of the study).

Selecting the screen failure status results in the patient's inability to continue the examination - this is the last possible status.

  NOTE: In the case of re-screening - the system allows the same patient to be added to the examination again, provided that he has been marked as a screen failer.

After selecting the status and pressing "Finish appointment", the system will automatically update the patient's status.

4. At the end of the next visit, the system will ask again to update the patient's status.

Moving from the Run-In status, the next patient status can be ongoing (if the patient is in the active phase of the study), Early termination (if the patient is excluded from the active phase of the study), Lost to follow-up (when contact with the patient is lost), drop -out (if the patient has withdrawn from the study).

The choice of the Lost status is follow-up or drop out - the patient's participation in the study is terminated and it is not possible to arrange another visit as well as the standard change of status is not possible.

POSSIBILITY OF MANUAL STATUS CHANGE

In exceptional cases (e.g. as a result of an incorrect status change), it is possible to edit it manually.

In order to make such a change, the user must have a dedicated authorization: Study patients - status change, if you do not have such an option, ask your supervisor to indicate you a person who has the appropriate authorization.

1. Click on the three dots on the selected patient in your clinical trial patient list, then select: Change Status

2. Select the new status that the indicated patient should have (you can choose from all that currently exist in the system), complete the comment (this field is mandatory, because the natural logic of the system is bypassed - it is therefore advisable to include information justifying the change of status)

4. Once a change is made, it is saved in the patient's status change history