Study launch checklist

What to check before enrolment starts and how to delete test patients at the launch.

While a study is being set up (status Setting up), its overview shows the launch plan. The steps tick themselves as you complete them; the launch is the last one.

The launch plan from top to bottom. At the launch, test patients can be deleted together with all their data.

Before the launch

1. Describe the study. Sponsor, enrolment target and a short description: the team sees them on the overview.
2. Add the sites. The site number is part of the patient ID (REGDIA-01-0005): check it before the first patient is enrolled.
3. Invite the team. At least one investigator and one monitor; each person gets a role and sites.
4. Build the eCRF. Visits with windows, forms, fields and edit checks; every visit needs at least one form with fields. Are all the protocol fields there? Do numeric fields have ranges?
5. Try it on a test patient. Enrol a patient, fill in every form and enter wrong values on purpose: you will see the edit checks at work and whether the forms are convenient for the investigators.
6. Launch the study. The Launch button at the bottom of the plan.

Test data at the launch

Patients enrolled while the study is being set up are test patients. Next to the Launch button there is a box “Delete the test patients and their data”, ticked by default. If it stays ticked, the test patients are deleted with their forms, queries and personal links. The audit trail keeps a record of the launch and of how many test patients were deleted.

Untick the box if the patients entered during set-up are real, for example when data has been moved from paper forms.

The launch cannot be undone: the status changes to Enrolling, and from then on every change is recorded in the audit trail. The database can be locked later in the study settings.

Can the forms be changed after the launch?

Yes. Fields, edit checks and visits can be added in the eCRF builder. A field or form that already holds data cannot be deleted, and the code or type of such a field cannot be changed: this protects the data already collected. Every change is in the audit trail.

Example: the ePRO pilot DEMO-EPRO

In the demo data, the study DEMO-EPRO “ePRO pilot: symptom diary” is still being set up. One test patient, DEMOEP-01-0001, has been enrolled, so the step “Try it on a test patient” is ticked: one step of six. The others are still waiting: there is no sponsor or description yet, the team is the manager alone, and the eCRF is empty.

When everything is ready, the manager clicks Launch and leaves “Delete 1 test patient and their data” ticked. The status becomes Enrolling, the test patient disappears, and the audit trail shows the launch with “1 test patient → deleted” and the reason “test data cleared before the launch”.

The launch plan of DEMO-EPRO: one step of six is done, one test patient will be deleted at the launch.

When informed consent is on in the study, the plan has the step Set up informed consent: the version of the consent form or a basis without consent. Then a patient's data is entered only after their consent is recorded. You can go back to the finished steps: they keep their button.