Manage Participants in a Project

What this is

A participant is a person enrolled in, or being screened for, one project. The project's Participants list shows everyone in the study you can access, and each participant has a record where you conduct their visits, enter and review their data, and manage their study status.

Participants and the patient database work together:

• A person in the Patient database can join many projects. Each project they join creates one participant.

• When a participant is linked to a patient database record, their name and contact details come from that record, and the participant record shows a Patient Information tab.

• A participant can also be created with no name or contact details at all, identified only by their participant ID.

When to use it

• You need to see who is in a study, their status, and when their next visit is.

• A new person consents and joins the study.

• You need to change a participant's status, such as moving them from screening to enrolled, or withdrawing them.

• You need to correct a participant ID.

Before you start

• You need a clinical user type on the project that lets you open participants. You only see participants at the sites you are assigned to.

• Creating participants and changing status each need their own permission. If you do not see Create participant, or the status cannot be changed, ask your administrator.

• The project needs a default participant status and at least one site. The study builder sets these up.

Use the Participants list

1. Choose the project in the project switcher in the sidebar, then click Participants under it.

2. Type in Search to find participants.

3. Optional: Click Filters and choose a Status or Site. Click Clear filters to remove them.

4. Optional: Click Columns to choose which columns appear. Participant ID, Name, Status, Next visit, Last visit, and Flagged Notes show by default. Site, Project, Phone, Email, and Time zone can be added.

5. Optional: Click the Participant ID or Name header to sort ascending or descending.

6. Read the key columns:

   • Participant ID is the study identifier.

   • Name shows Restricted when you do not have access to personal information (PII).

   • Status is the participant's current status in the study.

   • Next visit shows the next scheduled visit. Unscheduled means a visit is due but has no appointment. Nothing scheduled means there is no upcoming visit.

   • Last visit shows the most recent visit.

   • Flagged Notes shows how many notes on the participant are flagged as needing action.

7. Click a participant to open their record.

Create a participant

Choose the project and site

1. On the Participants list, click Create participant. The New participant dialog opens. You can also use Add participant in Quick actions on Home. When you start outside a project's pages, the active project is selected for you, and you can change it.

2. Choose the Project and Site. Anything you have only one of is filled in for you. The site decides which participant ID sequence is used and which staff can see the participant.

3. Click Continue.

Enter details

1. Choose where the person's information comes from:

   • Add an existing patient fills in the details from this site's patient database. Search by name, date of birth, or CB-ID and choose the person. Use this whenever the person is already in the patient database, so they keep one record across studies.

     • If you click Edit on the prefilled details, the change updates the person's record in every project they are in.

     • People already in this project are marked as such and cannot be added again.

     • People marked Do not contact cannot be added.

   • New participant lets you enter the information yourself. When you enter a name or contact details, Sitebase also adds the person to the patient database.

2. Optional: Enter First name, Last name, and Date of birth. These can be left blank for a participant identified by ID only.

3. Optional: Enter an Email and Mobile phone. They must be valid if entered.

4. Set the Participant ID. How it behaves depends on the project's setup:

   • Generated automatically when the participant is created means you do not enter anything. The ID is assigned when you create the participant. Generated IDs depend on the site's project site ID, so if the ID cannot be generated, ask the study builder to complete the site's setup.

   • Otherwise, enter the ID. It must match the format shown, be 128 characters or fewer, and not already be used in the project. The field shows an example of the expected format.

   • Optional: If the project allows it, click Add alternate identifier to record a second ID.

5. Review the Initial status. It is the project's default status and cannot be changed here.

6. Confirm the Timezone. It is used to schedule the participant's activities and visits in their local time. Click Change to pick another. A timezone is required.

7. Click Continue. If the details match someone you can access, Possible duplicate appears with what matched (Name and date of birth, Email, or Phone). Click Open to use that record, or Continue with new person. A match you cannot open shows Possible match (restricted).

Review and create

1. On Review, check each row. Click Edit to return to any step. If you left out name and contact details, Review notes that the participant is identified by participant ID only.

2. Click Create participant, or Create & add another to save and start the next one.

3. If you close the dialog before creating, Sitebase asks you to confirm before discarding your entries.

To add many people from the patient database at once, use Add from patient database (see the patient database guide).

Navigate the participant record

When you open a participant, the top bar shows Participants, the participant ID, and the page you are on. Click Participants to go back to the list.

The participant header shows:

• The participant's name, first and last only. You see the name only if you have access to personal information (PII). Otherwise the header shows the participant ID.

• Participant ID, Study ID, Email, and Status, each with a copy button. Email appears only with PII access. Values that are empty are hidden.

On a tablet or phone, the tabs are replaced by a page switcher next to search, which opens a grid of the participant's pages. The participant's details move into a Properties panel that you open with the arrow beside the participant ID.

Each tab covers one part of the participant's study record. Some tabs only appear when the project uses the related feature or you have access.

Change a participant's status

The study builder defines the statuses for each project, so the list differs by study. Some statuses are terminal, meaning participation has ended.

1. Open the participant record and go to Information.

2. Click the status and choose the new one from Participant Status.

3. In Set Participant Status, enter a Reason. A reason is required for every status change and is recorded in the participant's history.

4. Click Set Status.

5. If the new status needs an identifier the participant does not have yet, Identifiers required opens. Enter the identifiers and click Save and advance.

When the new status is terminal:

• Sitebase asks you to confirm because any remaining activities are cancelled.

• New activities and log entries cannot be added for the participant.

A status marked as Deprecated is no longer used by the study. It still shows on participants who already have it, but cannot be chosen.

Use participant actions

On Information, Participant Actions has actions that change how the study runs for this participant. Each one needs its own permission. A button you cannot use shows why when you point to it.

• Stop Workflow cancels all of the participant's open activities and stops new activities and notifications from being generated. Completed activities are not affected. Use it to pause the study schedule for a participant. Afterwards, the section shows Workflow Stopped.

• Resume Workflow restarts a stopped workflow, so new activities and notifications begin generating again.

• Withdraw permanently ends the participant's participation in the study and cancels all scheduled activities. It cannot be undone, so use it only when the participant has withdrawn or been withdrawn from the study.

• Reset PIN deletes the participant's current PIN for the participant app. They set up a new PIN the next time they sign in. It is unavailable when the participant has no PIN.

Edit a participant ID

1. On Information, find the identifier and click its edit button.

2. Read the dialog. Editing an assigned identifier is recorded in the participant's audit history.

3. Enter the New value. It must differ from the Current value, match the format, and not be used by another participant in the project.

   • For an auto-generated identifier, saving replaces the current value with the next available generated value instead.

4. Click Save changes.

Tips

• Search the patient database before creating a participant, and use Add an existing patient when the person is there. It keeps one record per person across studies.

• Use Stop Workflow to pause, and Withdraw only when participation has ended, because withdrawal cannot be reversed.

• Write status change reasons that a monitor can understand without asking you, since they are part of the study record.

Still need help? Submit a help request here.