Recording a visit is the daily work of the eCRF. This article covers the site's side of it: opening the right form, entering data, and what to do when an answer is not available or turns out to be wrong.

🔑 Prerequisite: eCRF Records (Edit), a study in Live status, and the subject already included.

🔬 Explore how it works

Click through this interactive guide to learn the process in seconds.

Open the subject's visit

The tree on the left lists every visit in the study, and the forms inside each visit. You can collapse it, hide it, or resize it to give the form more room.

🛠️ Step by step guide

Open the study and go to eCRF > Inclusions list.
Click the subject's row to open their eCRF.
In the tree on the left, click a visit to expand it, then click the form you want to complete.
Use Next form and Previous form at the bottom of the page to move through the forms in order. On the last form of the eCRF the button reads End eCRF instead of Next form.

💡 Tips

Collapse all at the top of the tree is quicker than scrolling when a study has many visits. The percentage next to each visit tells you where to pick up.
You can switch to another subject without going back to the Inclusions list, which saves a lot of clicking when you are working through several in a row.

Record the answers

There is no Save button. Every answer is saved as you enter it, so you can leave a form part-completed and come back to it later without losing anything. Questions marked with a red asterisk are required. Each visit and each form shows a percentage, and each question carries a colored dot showing where it stands.

Dot	Status
Grey	Not started
Blue	In progress
Green	Completed
Orange	A query is open on this question
Yellow	A query on this question is in verification

💡 Tip: there is no legend on screen, so the colors are worth learning. Excluded is a status of the eCRF, not of a question: you will see it on the subject, never on a data point. The verification status only occurs on studies where eCRF Review is switched on, under Settings > Options, which is optional and off by default.

⚠️ Warning: a required question left empty does not block you, but it does keep the form below 100% completion. Clicking Next form shows the warning "Not all required questions are answered". Click it again and you move on anyway. Nothing stops you from leaving a visit incomplete, so check the percentage before you consider a visit done.

Add rows to a repeated measure

Some forms hold a question that can be answered several times over: concomitant medications, adverse events, and anything else where the number of entries is not known in advance.

🛠️ Step by step guide

Open the form containing the repeated measure.
Click + Add New Measure, Event or Report.
Complete the entry.
Click + Add New Measure, Event or Report again for each additional entry.

💡 Tips

There is no fixed maximum. How many entries you can add is whatever was configured for that question in the Builder, so it may be 8 on one study and 50 on another. If you run out of room, the study team can raise it.
In the export, repeated measures can either come out as extra columns in the main sheet or on a sheet of their own.

When an answer fails a check

Data validations are set up when the eCRF is designed. What you see depends on the severity the designer chose.

Severity	What you see	What happens
Information	A blue banner with a message	Nothing else. The message is guidance.
Warning	An orange or yellow message	An automatic query is created
Exclusion	A red message	An automatic query is created

None of the three stops you from continuing. An automatic query still has to be answered later, by you or by your site, so reading the message when it appears is faster than answering the query it generates.

⚠️ Warning: in the ePRO the Exclusion severity behaves differently. There it blocks the participant from going further. Same setting, different consequence, so do not carry the eCRF behavior over to an ePRO form.

What else you can do on a question

The ··· menu on each question holds the actions available to you. Queries appear directly below the field they belong to, so you can see and answer them without leaving the form.

Add query: raise a query on this data point.
Audit trails: the full history of this data point, including who changed it and when.
Missing/Unknown: declare that the answer is not available. You choose a standard reason and add a comment. See Handle Missing Data for the reasons and how each is coded in the export.
Change answer: appears only when your study has the reason for change option enabled.

Once an answer is declared missing, the form shows a blue banner under the question reading Missing/Unknown answer reason, followed by the reason chosen.

The three icons on a visit or a form

Icon	Action	Available on
Padlock	Lock	A form, a visit, a whole eCRF, or several eCRFs at once
Pen	Sign	A visit, a whole eCRF, or several eCRFs at once
Question mark	Declare missing data	A question, a form, a visit

⚠️ Warning: the same three icons follow you in the panel on the right edge of the page as you scroll, which is quicker than returning to the tree on a long form. But they do not all act on the same thing: the padlock and the missing data icon apply to the form you have open, while the pen applies to the whole visit it belongs to.

💡 Tip: declaring a whole form or a whole visit as missing, rather than one question at a time, is what you want when a subject is lost to follow-up. To act on several subjects at once, tick them in the Inclusions list and use the actions in the blue banner at the bottom of the page.

Change an answer you have already saved

There are two behaviors, depending on how your study was configured.

You can click a different answer directly. The change is recorded in the audit trail with your name and the time.
You cannot change it directly. Open the ··· menu, select Change answer, give the reason, then enter the new value. The reason is recorded in the audit trail alongside the change.

If you cannot simply click another answer, the reason for change option is switched on for your study. It lives under Settings > Options > Enable GCP > Reason for change, so it is a study-level decision, not something you can turn off yourself.