A working study database is mostly a protocol read, a form list and a test run. This hour-by-hour plan shows what a focused team can build in a day, what it should not skip, and what belongs in the second week.
Free sandbox · No credit card · 21 CFR Part 11 aligned
11
visits
9
draft forms
2
diaries
What a one-day build means
Be realistic
Traditional EDC builds are slow because a vendor team takes requirements, writes specifications, programs the forms, and sends them back for review. When your own team builds directly in a visual builder, most of that hand-off disappears. A single person who has read the protocol can create visits, forms, edit checks and roles in hours. That is the premise here, and it is why rapid study setup is a realistic goal for the right study.
What a day does not include is the paperwork and approvals around the build: your internal review of the data management plan, user acceptance testing by someone who did not build it, ethics approval, and training. Plan those separately and run them in parallel. If you are weighing doing this yourself against paying for a build, read build versus buy.
The plan
| Time | Task | Output |
|---|---|---|
| Hour 1 | Read the protocol, list visits and assessments | A visit-by-measure grid |
| Hour 2 | Create the study, arms and visit schedule | Visits with windows |
| Hours 3 to 5 | Build or import forms: eligibility, demographics, vitals, labs, AEs, medications, study-specific | Draft forms |
| Hour 6 | Add edit checks, skip logic and calculated fields | Forms that catch errors at entry |
| Hour 7 | Set roles, sites and participant numbering | Users with the right access |
| Hour 8 | Enter test participants through two visits | A list of defects |
| End of day | Fix defects, approve forms, export a test file | A build ready for review |
A guide for a focused build, not a guarantee. Time depends on protocol complexity and how many forms you need.
Step by step
Have the final protocol, the schedule of assessments, the list of sites and users, and any source forms to hand. Decide who will build and who will test. If the protocol is a PDF or Word file, Capture can draft visits and forms from it; nothing is saved until you review it.
Turn the schedule of assessments into a grid: rows are measures, columns are visits. Every tick becomes a form at a visit. The schedule of assessments builder does this in the product. Set visit windows now, since they drive overdue flags later.
Start from templates for the standard forms: demographics, vital signs, medical history, concomitant medications and the adverse event form. Then add the study-specific forms, using AI drafting from a description or source file where it saves time.
Add range checks on numeric fields, skip logic where a question depends on another, and calculated fields for derived values such as BMI. Edit checks raise an automatic query when a value breaks a rule, so cleaning starts at entry. See edit checks software.
Create the roles you need, assign sites and participant numbering, and check what each role can see. Blinded roles should never see treatment-arm values. If you randomize, configure it and test it with dummy participants.
Enter at least two test participants through two visits, including an out-of-range value, a missed visit and an adverse event. Check the audit trail records each change. Export the data and open the file the way your statistician will.
Approve the forms that passed testing; approved forms lock for live use. Then stop. Leave consent, training and go-live decisions for when your reviewers have signed off.
Second week
Be honest about what a one-day build skips. User acceptance testing is stronger when done by someone other than the builder, using written test cases. Your data management plan should describe how data will be entered, cleaned and locked, and the data management plan template is a start. Training for site staff, monitoring plans and consent forms also take their own time.
If your organisation must validate the system for regulated use, remember that responsibility for compliance with rules such as 21 CFR Part 11 is shared between the software and how you use it. Capture provides controls such as a field-level audit trail, electronic signatures and role-based access, and documentation to support your validation. Your own SOPs and testing still apply; see the 21 CFR Part 11 compliance checklist. This is not legal advice.
Day one produces a tested build. Days two and three belong to an independent reviewer who works through written test cases and logs defects. Days four and five are fixes, retest and approval of the forms. In parallel, a different person drafts the data management plan, prepares user accounts and writes short site instructions. That split keeps the builder from marking their own homework, and it means go-live waits on approvals and training rather than on software.
Keep a simple build log as you go: what you built, which protocol version it matches, who tested it and when. If the protocol changes later, the log shows which forms to revisit, and the record supports any validation questions from a sponsor or inspector.
Upload a protocol, review the draft, test with sample data. No credit card, no time limit, pay only when you go live.
Before you call it done
Cross-check the visit-by-measure grid against the forms list.
Windows defined so overdue visits are flagged.
Each check tested with a value that should and should not trigger it.
Each role signs in and sees only what it should.
A changed value shows old value, new value, user, time and reason.
Wide-format file and data dictionary checked against the analysis plan.
Only tested forms approved for live use.
For a small or focused study with a finished protocol, a first working build in a day is realistic when your own team builds directly. Review, user acceptance testing and approvals still need their own time.
The final protocol, the schedule of assessments, a list of forms, sites and users, and any source documents to draft forms from.
Capture can draft visits and forms from an uploaded protocol or source file. You review everything, and nothing is saved without your approval.
Not until it has been tested, reviewed and approved under your own procedures. Approved forms are locked for live use in Capture.
Enter test participants through several visits with deliberate errors, check edit checks and the audit trail, and export the data.
Building and testing in the free sandbox costs nothing and needs no credit card. You pay only once you go live with real participants.
Yes, through your change process. See the guide on protocol amendments without change orders.
Keep exploring
Rapid study setup EDC
The product side of fast builds.
Schedule of assessments builder
Visits and forms from a grid.
How to design an eCRF
Form design principles.
Protocol to study setup
Draft a build from a protocol.
Data management plan template
Document how data is handled.
Protocol amendments without change orders
Changing the build later.
Free sandbox with every feature. No credit card, pay only when you go live.