How can I enroll new subjects into my study?

Learn how to enroll a new subject in your study.

Subject enrollment

First, go to your subject overview.

In the study overview, click on "Enroll new subject" and a new window will pop up looking like this: 

	Choose the corresponding site from the dropdown menu.
	If you leave this field empty, the system will automatically generate a unique number for this patient called SIC (Subject Identification Code). You can also type in an individual Patient ID if you prefer. Please make sure not to use any special characters in the subject ID. The only special characters that can be used are the following: ‘-’ (hyphen) or ‘_’ (underscore).
	You can choose an assignee from the dropdown menu. This is a person you want to assign the subject to. For example, if you are a study nurse you might enroll the new subject but you may want to assign a doctor to be the assignee for this subject.
	Type in a phone number if desired. If your study contains ePROs, then an email address is mandatory.
	If translations are used, set the subjects contact language, which is the language that all subject-facing emails will be sent as well as the ePRO questionnaires will be displayed in.
	For usage of ePRO you can additionally select a data collection method. For example, if a subject is not confident in using a link, you can also enter the data manually.

You will be taken back to the Subject Overview of the Study.

If you are authorized to do so, you can easily archive an entry, re-enroll subjects, update the SIC, assignee or site any time like this:

	Check the box to the left of the subject you wish to update.
	Then, go to the button "Actions" and click on the Action you wish to proceed with:
	Archive entry: If you are archiving a subject entry, a warning message will appear: Archiving entries will also archive all associated (S)AEs and queries! Archiving entries will be shown in the audit trail.  Please note: If the patient to be archived is the last patient created for the respective so far, the consecutive patient number is skipped when a new patient is created. Example: Patient 00010024 is archived. The next patient receives the SIC 00010025.
	Re-enroll (similar to re-screen): If you click on "Re-enroll" then you will be asked to choose a starting step for your subject. If you leave this field empty then your subject will be enrolled in the first step.
	⭐ If you are re-enrolling a subject, the SIC will stay the same, but you freeze all data entered so far (status will change to "re-enrolled") and a "fresh version" of this subject will be created with the same SIC and the status "active" but no data entered so far. For the "old" version of the subject called with the status "re-enrolled" the following applies:  ✅ You can still lock & sign forms ✅ Creating and updating of queries is possible  ⚠️ The data of re-enrolled subjects cannot be edited anymore ⚠️ You cannot export data as PDF This is what the action of re-enrolling will look like:

For more information about the remaining Actions, take a look into the respective articles:

How do I report an (S)AE?

How do I report an unscheduled event?

Subject Overview in a study

Sample Module (in progress)

One Device Enrollment

The premium feature "One Device Enrollment" may be used for your study. This means that one and the same e-mail address can be stored in the subject profile for several subjects. A typical use case for this is the following situation: In the study, tablets are distributed to the patients on site at the center so that they can answer their questionnaires on these devices. Since this device has only one email access, all subjects are enrolled with the same tablet email address.

The first enrolling of a subject with the email address works as usual. If you now enter the same email address for the second or all subsequent subjects, you will receive a warning message from the system confirming that the same email address has already been used for another subject. If the premium feature "one device enrollment" is enabled, you can click on "Confirm and save". The subject will be enrolled in the system.
For a better distinction of the respective sent emails and/or SMS for the ePROs, the SIC (subject identification code) is displayed in the subject as well as in the text message itself.

Video

One Device Enrollment

Picture yourself in charge of a pediatric study, where a family wants to enroll both children, but can provide only one email address for the ePRO completion. You might also want to use a tablet (one device) if your subjects complete ePROs only on-site instead of having them use their own device and e-mails. But you want to avoid creating one specific generic email per subject.

Regardless of the circumstances, you have the flexibility to allocate a single email to multiple subjects while ensuring that each subject receives the appropriate ePRO weblink. In this video, you will learn how to use this function.

Please note that this feature needs to be enabled for your study.