This article provides guidance on designing, managing, configuring, and publishing eCRF forms for your study. These forms are used to generate eCRF records for your subjects. The eCRF module is available within a clinical EDC study.

Create and build a new eCRF form

It can exist only one eCRF form under a clinical EDC study.

🛠️ Step-by-step guide

Pre-requisite: How to create a new study

Navigate to "studies"
Select "+Create a new study"
Complete the studies details
- Study name : Study description accepting a long text
- Study reference : Study short ID. Must be unique over all existing studies
- Study centers : Centers connected to this study.
- Main contact : Project Manager name
- Number of inclusions needed : Subject complete case targeted on the study statistic inital definition
Select Save

How to create a new eCRF from scratch

Navigate to "studies", open the study under which to create an eCRF
Select "eCRF" builder
Choose "Build from scratch"
Configure your sections, subsections, questions, and conditions.

Limit visibility or access to eCRF details

You can easily configure your eCRF to control who can access or modify information at different levels, ensuring secure and restricted data handling.

🛠️ Step-by-step guide

How to Limit Access to a Section or Subsection:

Open the eCRF Builder.
Select "Structure" from the menu.
Locate the desired section or subsection row.
Click on the logo
Select the roles that should not have access to the related page(s).
Repeat the action for the different section , subsections

💡 Tip : By customizing access permissions, you can ensure that only authorized users can view or modify specific sections of the eCRF.

🛠️ Step-by-step guide

How to limit access to an eCRF question

Open the eCRF Builder.
Locate and open the question you want to configure.
Select "Edit".
Navigate to the "Advanced" tab.
Use the available options to configure access:
- Exclude from Data Exports: Prevent this question from being included in any data exports.
- Hide in eCRF: Make the question invisible in the eCRF. This is useful for creating system calculations or hidden questions that should not be displayed.
- Role-Based Edit: Specify roles that are allowed to edit this question.
- Role-Based Visibility: Restrict roles that are allowed to view this question.

💡 Tip : By applying these restrictions, you can ensure that sensitive or system-related questions are managed appropriately and securely.

Test an eCRF

Testing your eCRF form is essential to ensure it is designed as intended. Investigators will see all sections, subsections and questions.

It’s important to test the form after each modification to achieve an efficient and user-friendly design. The steps below apply to both creating a new form and editing an existing one, as long as the form is in Draft status.

🛠️ Step-by-step guide

How to test an eCRF form

Keep your eCRF form builder open
Open another Datacapt browser study page
Navigate to “Inclusion List”
Generate a new test eCRF
Test your ePRO Form

💡Tip: While the test ePRO record remains incomplete, you can apply an agile approach by making live modifications in the ePRO Form Builder on one browser tab and instantly verifying the results in the other. This ensures an efficient and iterative design process.

Publish an eCRF

After testing and validating your eCRF questionnaire, you can change the study status to "Live" to begin collecting participant data.

🛠️ Step-by-step guide:

How to set-up a study as "Live"

Open the related EDC Study containing the eCRF.
Navigate to the "Settings" section.
Under the "General" tab, select "Edit".
Change the study status to "Live".
Save your changes.

⚠️ Important: When the study is "Live":

All previous test records will be deleted to ensure patient data remains separate from test data.
The eCRF Builder will be locked to prevent further modifications.