One Builder serves five modules: eCRF, ePRO, eConsent, Recruitment and the Subject database. Learn it once and you can build in all of them. This page gives the eight steps in working order, with the guide to open at each one.
š Prerequisite: the Builder (Edit) permission of the module you work in. For an eCRF, a study in Draft or Suspended status.
1. Start from a template or from a blank form
When you open an empty Builder, Datacapt offers Build from scratch or Choose from templates. Demographics, vital signs, adverse events and concomitant treatments change little between protocols, so check your library before you build them again.
You can also bring in a single visit, a single form or a few questions later, with the + button of the toolbar.
2. Create the structure
A form has two levels: sections, and sub-sections inside them. In an eCRF a section is a visit and a sub-section is a form of that visit. Build the whole tree in the Structure view first, then fill it. Drag the handle on the left of a row to reorder.
3. Add questions and name your variables
Open a sub-section and select Add question. The menu has three groups.
Group | Blocks |
Question | Text input, Checkbox, Radio buttons, Date/time, Number value, Rating, File upload, Slider, Calcul, Dropdown |
Static content | Instruction, Header, Image |
Other | Repeated measures, Table/Matrix, Add from template, ePRO invitation, Randomization, Allocation |
Two choices cause most of the rework:
Radio buttons take one answer, Checkbox takes several. Changing one into the other after data collection starts changes your export columns.
Each question has a Variable name, which becomes the column header of your export. Type it yourself. A name left empty becomes something like
TEMPE_WR6KT9.
š” Tip: for anything a participant completes alone (ePRO, eConsent, Recruitment, Subject database), add an Instruction block before each group of questions. Nobody stands next to them to explain.
4. Add the logic
The editor of a question has five tabs: Edit, Conditions, Data validation, Display data and Advanced. Three of them hold the logic of your form.
You want to | Use | Guide |
Show a question, a form or a visit when an earlier answer calls for it | Conditions | |
Compute a score, a BMI, an age or a target date | A Calcul question | |
Catch a wrong value at entry, raise an automatic query, or exclude a candidate | Data validation, with four outcomes: Information, Warning, Exclusion, Disqualified | |
Show an earlier answer next to the current question | Display data |
5. Restrict by role
On the Advanced tab of a question, Role-Based Visibility and Role-Based Edit decide which roles see or edit it. On a section or a sub-section, Exclude roles closes the whole block to the roles you select. Blinded studies depend on these settings.
ā ļø Warning: a template does not carry role restrictions. After you apply one, set them again.
6. Duplicate instead of rebuilding
Duplicate a question, a sub-section or a whole section. For a visit that repeats, build it once, give the section a prefix such as V1, duplicate it and change the prefix to V2. Every variable stays unique.
7. Test as you go
Test each sub-section when you finish it, on a test subject, logged in with a site role. The eye icon of the toolbar previews the form without leaving the Builder.
š” Tip: a mistake caught in the first sub-section costs one fix. The same mistake caught at the end sits in every section you duplicated from it.
Testing and publishing differ per module:
8. Translate, print and go live
Translate the form for each country of the study. See Configure translations for multi-language studies.
The printer icon of the toolbar exports the empty form as a PDF, in each translated language. File it with your validation report.
Before you set an eCRF study Live, run the Go-live checklist. Going Live deletes test data and locks the Builder.
The Builder toolbar
Icon | Does |
Magnifier | Finds a question by its title or its variable |
Eye | Previews the form as the site or the participant sees it |
Printer | Prints the empty form |
+ | Inserts a template |
Save as a template | Saves this form for reuse |
For the ceilings of the Builder (questions per form, options per question, file sizes), see Builder limits and what Datacapt does not do.