Becoming a REDCAP cloud superuser: patient enrollment, all the shades of REDCAP cloud

You need to create a new eCRF in REDCAP cloud and you want to be sure to set up the patient enrollment as best as possible, but you know only one way to do it.

Well in REDCAP cloud we have at list 5 different strategies:

 1) - no screening/ no enrollment:

the easiest thing is to leave everything as default, it means no screening CRF or enrollment CRF; this automatically qualifies ALL the patient to be eligible for the study, that's it.

How does it work?

When the operator "Add" a new patient, simply assign the subject id and to continue with the event assignment step (I strongly discourage to manually assign the subject id unless you must, I will discuss this topic in a future article);

 2) - screening CRF with no enrollment confirmation:

a second approach is to use a dedicated CRF to test if the patient is eligible or not.

First: activate the "Use Screening CRF" option under "STUDY"--> "Parameter"--> "Subject Parameters";

Second: create a new CRF (call it "Screen" for example), check the "Enroll Screening" combo box under "Instrument Definition", add the variables and finally implement the Screening expression (i.e. [QST1]=1 and [QST2]=2, where VAR1 is inclusion criteria and VAR2 is exclusion criteria).

How does it work?

When the operator "Add" a new patient, select the Screening CRF, reply to the questions, click "Save and exit" and if the patient passed the screening, the following writing will appear "Subject qualifies for enrollment.", then continue with the event assignment step;

3) - screening CRF with enrollment confirmation and no "Reason for Non-Enrollment":

a third approach is to use a dedicated CRF and to ask for enrollment confirmation.

You follow all steps described at point 2), then you go back to "STUDY"--> "Parameter"--> "Subject Parameters" and check the "Confirm enrollment?" combo box.

How does it work?

When the operator "Add" a new patient, everything is the same as point 2), but if the patient passed the screening after the writing "Subject qualifies for enrollment." appears, reply Yes or No to confirm or not the enrollment, then continue with the event assignment step;

4) - screening CRF with enrollment confirmation and with "Reason for Non-Enrollment":

a fourth approach is an upgrade of point 3).

You follow all steps described at point 3), then you go back to "STUDY"--> "Parameter"--> "Subject Parameters" and select "Required" from the drop-down menu at the right of "Reason for Non-Enrollment".

How does it work?

When the operator "Add" a new patient, everything is the same as point 3), but if the enrollment is not confirmed, a text box appears allowing the operator to describe the reason why the enrollment was not confirmed;

 5) - enrollment CRF:

another approach is to not use a screening CRF but an enrollment CRF.

What is the difference?

If you want to skip the screening step and you only need to know if the patient is eligible for enrollment or not, you must use an enrollment CRF.

First: activate the "Use Custom CRF for Enroll" option under "STUDY"--> "Parameter"--> "Subject Parameters";

Second: create a new CRF (call it "Enroll" for example), check the "Enroll Custom CRF" combo box under "Instrument Definition" and add the variables.

How does it work?

When the operator "Add" a new patient, assign the subject id if he/ she must do it, the "Subject qualifies for enrollment." writing will appear, then the operator must answer to the enrollment question, then continue with the event assignment.

 Subject enrollment is a very important step and REDCAP cloud give us few options to implement it.

 Which is your favorite?