Building an eCRF is four steps: create the form, set up the logic that keeps the data clean, test it, publish it. The advanced options at the end of this article are useful but optional, and most studies never need them.
🔑 Prerequisite: eCRF Builder (Edit), and a study in Draft or Suspended status. If the study does not exist yet, create it first: go to Studies, select + Create a new study, complete the study name, the study reference (a short ID, unique across all studies), the study centers, the main contact and the number of inclusions needed, then Save.
Step 1. Create the form
A clinical EDC study contains one eCRF form. You build it once, and organize visits as sections and the forms within a visit as sub-sections.
🛠️ Step by step guide
Go to Studies and open the study.
Select eCRF Builder.
Choose Build from scratch.
Select Structure, then use Add subsection on a section to build your visits and forms. Drag the handle on the left of any row to reorder.
Open a form and use Add question at the bottom to add questions. Each question gets a Variable, which is the column name in your export.
Click Save.
The badge next to each section name is the number of forms it contains, so you can check the structure at a glance without expanding anything. The toolbar at the top right of the Builder holds the tools you will use most.
Icon | Does |
Magnifier | Find a question by its title or its variable, and jump to it |
Eye | Preview the form as the site will see it |
Printer | Print the empty eCRF |
+ | Import a template |
Save as a template | Save this eCRF for reuse on another study |
💡 Tip: on a study with hundreds of questions, the magnifier is faster than scrolling the tree. It searches the variable as well as the title, which is how a data manager finds the question behind a column in the export.
Step 2. Set up your conditional logic and data validations
This is the step that decides how much cleaning you do later. Both are configured per question, on the tabs of the question editor.
Tab | What it does |
Conditions | Show or hide this question, or prefill it, depending on another answer |
Data validation | Check the answer as it is entered, and raise a message or an automatic query when it fails |
💡 Tip: a validation written now costs minutes. The same error found after 200 subjects costs a query per subject. See Use conditional logic to show/hide content automatically and Create queries.
Step 3. Test before going live
Testing confirms the form behaves as designed. Investigators see every section, sub-section and question, so test after each change rather than once at the end.
🛠️ Step by step guide
Keep the eCRF Builder open.
Open a second browser tab on the same study.
Go to the Inclusions list.
Add a test subject and open their eCRF.
Complete the forms as an investigator would, and check every condition and validation fires as you designed it.
💡 Tip: while the test eCRF is still incomplete you can work on both tabs at once, changing the form in the Builder and checking the result immediately in the other tab.
Step 4. Publish the eCRF
Once the form is tested and validated, set the study status to Live to start collecting real participant data.
🛠️ Step by step guide
Open the EDC study containing the eCRF.
Go to Settings.
Under the General tab, select Edit.
Change the study status to Live.
Save your changes.
⚠️ Warning: setting a study Live does two things immediately.
Every test subject and all their data are deleted, so patient data stays separate from test data.
The eCRF Builder is locked against further changes. To change the eCRF later, set the study to Suspended, which reopens the Builder and locks data collection while you work.
Document your validation before you publish. Never publish a partially validated form: changing a live study is slow and can affect data already collected.
Advanced options
None of these is a step. Reach for them when your protocol needs them, and leave them alone otherwise.
Restrict access to a question
On the Advanced tab of the question editor, Role-Based Edit lets only the roles you select edit the answer, and Role-Based Visibility lets only the roles you select see the question. Switch the option on, then pick the roles in Selected Roles.
⚠️ Warning: turning on Role-Based Edit overwrites all existing permissions on that question. Review the roles you select before you save, because the previous configuration is not kept.
Restrict access to a whole visit or form
You can hide an entire section or sub-section from certain roles, which is quicker than doing it question by question.
🛠️ Step by step guide
Open the eCRF Builder and select Structure.
Hover over the section or sub-section you want to restrict. A crossed-out eye icon appears on the row.
Click it. The Exclude roles window opens.
In Select roles, choose the roles that should not have access.
Click Submit.
⚠️ Warning: the two levels work in opposite directions, and it is easy to lock out the wrong people.
On a question, Role-Based Visibility is a list of the roles that can see it.
On a section or sub-section, Exclude roles is a list of the roles that cannot access it.
Read the sentence in the window before you submit. It says "Please choose roles that are not allowed to access to this section".
💡 Tip: the crossed-out eye only appears when you hover over the row, so it is easy to miss. The same icon sits on section rows and on sub-section rows, and the window text changes to "this subsection" accordingly.
Hide a question from the eCRF, but keep it in the export
On the Advanced tab, Hide in eCRF makes the question invisible in the form while the data still comes out in the export. This is what you use for a calculation built across several steps, where the intermediate variables should never be shown to the site.
Keep a question out of the export
On the Advanced tab, Exclude from data exports removes the question from every export, in all formats. The question is still visible and still answered in the eCRF.
💡 Tip: the two options are opposites and easy to confuse. Hide in eCRF means the site does not see it but the statistician does. Exclude from data exports means the site sees it but the statistician does not.
Show an answer from an earlier visit
On the Display data tab, Remind question answer shows the answer given to a previous question next to the current one, so the site can compare rather than remember. Useful for anything measured at several visits. For the calculation types that build on this, see Add questions to your forms.