Roadmap: Adding patients to a study

1

Create the patient.

The patient reports to a site.

1. Select Create Patient ().
2. Click Yes, Create a new patient.
3. Fill in the fields as necessary.
4. Click Submit.

   The Patient Status Summary table on the Dashboard tracks the number of patients with each enrollment status.

2

View or view and sign any Informed Consent Documents (ICDs).

1. Create the patient.
2. Select Patients ().
3. Click the Summary link for the patient.
4. The patient views and signs any ICDs.
5. If required, a site user and an observer also sign the ICD.
6. Click Sign/Accept.

3

Complete any required screening forms to determine whether the patient is eligible to participate.

The patient is assigned to a site, visits are scheduled, and visits are populated with the required forms.

Site users:

• Complete any EDC forms for screening.
• If a patient fails screening, a site user with the appropriate rights must discontinue or re-enroll the patient.

  Patients:

• Depending on the study configuration, patients who enter data on ePRO forms may be notified through email that they have forms to complete.
• Complete any required ePRO forms for screening.

4

Complete any required forms for enrollment.

Typically, a site user completes any required EDC forms for enrollment.

The patient completes any required ePRO forms for enrollment.

The patient status becomes Enrolled when the EDC forms and ePRO forms required for enrollment are complete.