Manage eSource Data

Last updated: October 14, 2026

What this is

Source data is entered directly into Sitebase forms during or after a participant's visit, so the form is the original record. You work from the participant's Visits tab, where each visit lists the activities (mostly forms) the protocol calls for. Opening an activity shows its form in the panel beside the list.

Sitebase protects source data in four ways that shape how you enter it:

Data saves automatically when you leave a field. There is no separate Save button.
Late changes need a reason. Changing saved data more than 5 minutes after it was saved requires a reason for change, which is kept in the field's history.
Submitted forms are changed through an edit flow that captures what changed and why.
Forms can be signed off. If a form is configured for sign-off for your role, you sign it to confirm you reviewed it.

When to use it

A participant attends a visit and you need to record the visit's assessments.
You are transcribing data from paper or another system into the source forms.
You need to correct data on a form, before or after it was submitted.
You need to sign forms that are configured for sign-off for your role.
You need to record ongoing items such as adverse events or concomitant medications in a log.

Before you start

You need a clinical user type on the project that lets you enter and edit forms. With view-only access, forms open read-only.
You can sign a form only if it is configured for sign-off for your role.

Find the visit and activity

Open the participant and click the Visits tab. The page shows the visit list, then the selected visit's activities, then the open form. The first visit is selected when you arrive.
Optional: Use Filter visits to show All visits, Scheduled visits, or Unscheduled visits.
Optional: Use Toggle columns to add status columns to the visit and activity lists: Edits, Queries, Verified (SDV), Frozen / Locked, and Notes. Your choice is saved for both lists.
Click a visit to select it. Its activities are listed next to the visit list, each with its status.
Optional: Click Open visit details to see the visit's Status, Progress (how many activities are complete out of the total), visit window, when it was opened and closed, its description, and its appointments. On narrower screens the details open in a side sheet.
Click an activity to open its form. The form's status and timeliness badges show under its title.

To book an appointment for any of the participant's visits, click Schedule appointment at the top of the Visits tab. The visit you have open is selected for you. See Manage Appointments.

On a tablet, the visit list shows visits as tiles. Opening a visit shows only that visit, with arrows to move to the previous or next visit. A form opens in the page, with Submit in the footer and Next available form to move to the next form you can fill in.

Open and close a visit

Some visits are set up by the study to start only when site staff open them. These show an Open Visit button.

Open Visit starts the visit. The visit's activities become available to complete, and the visit shows who opened it.
Close Visit marks the visit as finished. The visit shows Closed with the time it was closed.

Visits that start automatically, for example on a date in the schedule, do not show these buttons.

Add an unscheduled event

Use this when an event occurs outside the planned schedule of assessments, such as an unscheduled visit.

On the Visits tab, click Add event.
Choose the event type in Select an event type.
Optional: Choose a visit in Link to a visit (optional), or No visit.
If the event includes documents to sign, assign each signer under Documents & signees.
Click Create.

You cannot add events for a participant with a terminal status, because their participation in the study has ended. If every available event is already scheduled, there is nothing left to add.

Enter data on a form

Open the activity from the Visits tab.
If Form outside scheduled window appears, read it. The form is late, missed, or not yet available, and submitting now may not comply with the protocol. Continue only if entering the data now is correct, for example when transcribing a visit that happened on time.
Enter the source data in each field. Sitebase saves each entry automatically when you move to the next field.
- Fields can appear or disappear based on data entered earlier in the form.
- Calculated fields fill in on their own and cannot be edited.
Use Next and Back to move between pages of a multi-page form.
Click Submit on the last page.
If required fields are blank, Sitebase lists them before submitting. Click Go Back to complete them, or confirm to submit anyway when the data is not available.
In Ready to Submit?, click Submit. After submitting, data can only be changed through the edit flow, which records each change and its reason.

Change data before submitting

Sitebase automatically saves entered eSource data. A form that has saved data but has not been submitted is marked In Progress.

If auto-saved data is changed more than 5 minutes after it was saved, a reason for change is required. Reason for Change required opens with the Previous and New values. Choose a reason and confirm. Entering data in a blank field for the first time does not need a reason.

Choose a reason for change

Every change to saved data needs a reason, except edits within 5 minutes and first-time entries. The project defines the reasons. The defaults are:

Data Entry Error: the value was typed or selected incorrectly.
Source Data Correction: the original source was corrected.
Transcription Error: the value was copied incorrectly from another source.
Response to Query: the change answers a data query.
Incorrect Participant/Visit/Form: the data was entered on the wrong record.
Other: none of the above apply. A comment explaining the change is required.

Reasons are recorded with the change and cannot be edited later.

Edit a submitted form

There are three ways to change a submitted form. Each one records what changed and why.

Edit one field

On the submitted form, click the field you need to change. Edit Response opens.
Make the change and choose a reason for change.
Click Save.

Uploaded files and images cannot be changed one field at a time. To change them, use Edit responses.

Edit several fields

On the submitted form, open Response actions on the Responses header and click Edit responses. A banner shows that you are editing the submission.
Make your changes. Required fields must be complete and valid, and at least one value must change, before you can resubmit.
Click Resubmit. Confirm Resubmission lists each change with its previous and new value.
Give a reason for each change, or turn on Same reason for all changes and give one Reason for all changes. A field cleared by branching logic is marked Cleared by branching logic.
Click Confirm Resubmit.

If values imported from other forms changed since the form was submitted, Sitebase asks whether to Use updated values or Keep original values.

Reopen the activity

Use this when the whole activity needs to be redone.

Open the activity's actions menu and click Reopen activity.
Enter the Reason for reopening. It is required, recorded for audit, and cannot be edited later.
Click Reopen Activity. The activity moves back to In Progress and existing data is kept, so you can change it and submit again.

Sign a form

If a form is configured for sign-off for your role, it shows Sign form once it is submitted. Forms that are not configured for sign-off for your role do not need your signature, and you will not be able to sign them.

Open the submitted form and read it to the end. Sign form stays unavailable until you have scrolled to the end of the form. If the form data changes before you sign, Sitebase warns you and you must review the form again.
Click Sign form. Ready to Sign shows the participant, project, site, and visit.
In Electronic Signature, re-enter your Email and Password, and choose the Reason for signing.
Click Apply signature.

The form then shows Form signed off with who signed, when, and the reason. Sign form is unavailable, with the reason shown, when:

The form is still in progress or has required fields that are empty.
The form changed since it was last reviewed.
The form is not configured for sign-off for your role, or the form does not need a signature.
The form is already signed.

Sign several forms at once

On the Visits tab, select the forms to sign and start sign-off. Sign-off eligibility lists the forms you can sign and any that cannot be signed, with the reason.
If the selected forms use different sign-off reasons, Select sign-off reason asks you to choose one. Forms with a different reason are skipped.
Click Start Signoff Queue. Review each form, using Next and Back, and Remove from Queue for any you do not want to sign.
Click Sign all forms and apply your signature once. You can sign up to 100 forms at a time. If you leave the queue before signing, Sitebase asks you to confirm, because none of the queued forms are signed and the queue is cleared.

When every form in a visit that needs sign-off is signed, the visit shows All applicable forms signed off.

Complete log forms

Log forms collect repeating entries, such as adverse events, medications, or procedures, that are not tied to one visit.

Open the participant's Log Forms tab, or the log activity from Visits.
Click Add entry and complete the entry. Each entry shows In Progress, Submitted, or Voided.
Submit each entry when it is finished.
To finish a log activity, click Complete activity:
- If entries still need attention, the dialog lists how many need attention and shows Resolve so you can fix them.
- If entries are ready to submit, Submit & Complete submits them and completes the activity.
- If nothing changed, Complete activity with no changes completes it without new entries.

Turn on Show voided to see voided entries.
When a log reaches the number of entries the study allows, no more entries can be added.
Changing a submitted entry more than 5 minutes after it was saved asks for a reason for change, the same as other forms.

Freeze or lock forms

Freezing and locking protect form data during review. Each action needs its own permission, so you may not see all of them.

Freeze stops field values from being edited. Queries and reviews can continue. You can freeze forms that are available, in progress, or completed.
Lock disables every action on the form. You can lock a form only when it is completed, has no open queries, has no fields pending SDV, and its PI sign-off is done. If something blocks it, Lock form shows Cannot lock: with the reason.

Freeze or lock one form

Open the form and click its actions menu.
Click Freeze form or Lock form. It takes effect right away.
To undo, click Unfreeze form, or click Unlock form, enter a Reason, and click Unlock.

Freeze or lock a whole visit

Select the visit and open its actions menu.
Click Freeze visit or Lock visit. Every eligible form in the visit is protected, including forms the visit filter hides. If some forms are skipped, Freeze results or Lock results lists them with the reason.

To protect several forms at once, select their checkboxes and use Freeze or Lock in the bar at the bottom. The Frozen / Locked column shows which forms are protected, and the visit header shows when every form in the visit is frozen or locked. Reopen activity is not available while a form is frozen or locked.

Cancelled activities

An activity shows Cancelled when it was cancelled, for example when the participant's workflow was stopped or they moved to a terminal status. A cancelled activity cannot be filled in. If it had responses, they stay visible as read-only.

Review other participant data

Documents & Files shows documents and every file uploaded to the participant's forms.
History on a form, and the form audit trail, show every change with who made it, when, and the reason.

Tips

Use Edit responses rather than reopening when only a few values change, because it keeps the form submitted and records each change.
Pick the most specific reason for change. Monitors read these reasons during review.

Still need help? Submit a help request here.