How to move a study from Excel or paper to an EDC
Spreadsheets have no audit trail and no edit checks. Move your study to an EDC in six steps, mid-study if needed, and keep the data you already hold.
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- Decide first: migrate the existing data or start new patients in the EDC.
- Map every spreadsheet column to a form, a field and a code list.
- Clean the legacy data before import and keep the original files.
- Check the import with record counts and a sample against the source.
A spreadsheet works for a pilot. At inspection it shows its limits: no audit trail, no edit checks, no access control per role and no electronic signatures. An EDC fixes that. You can switch between studies or mid-study, as long as you map, clean and check the data you already hold.
Migrate or restart?
For a new study, start in the EDC from the first patient. For a running study, you have two options: migrate the existing records into the EDC, or freeze them in the spreadsheet and enter new visits in the EDC. Migration gives you one dataset, and a clean cut-over goes faster when the old data is messy. Decide with your statistician.
How to move to an EDC in 6 steps
- Build the eCRF from the protocol. Use the spreadsheet as a checklist of data points, and design proper forms, visits and edit checks.
- Map the columns. For each column, record the target form, field, type and code list. Flag columns with mixed content, such as "5 mg twice a day" in one cell.
- Clean the legacy data. Fix dates in mixed formats, split combined cells and resolve duplicates. Keep the original file untouched for the record.
- Import and check. Load the data, compare record counts per patient and visit, and check a sample of values against the spreadsheet.
- Document the migration. Write what you moved, how, who checked it and what you left behind. Inspectors will ask.
- Train the sites and switch. Set a cut-over date after which nobody enters data in the spreadsheet.
Mistakes to avoid
- Copying the spreadsheet layout. A 200-column grid becomes a 200-field form. Rebuild the forms around visits.
- Two systems in parallel for months. Pick a cut-over date and keep to it.
- No record of the migration. Without it, the audit trail starts at an unexplained import.
Moving to Datacapt
Teams build their first study in Datacapt in days, with a visual builder, more than 25 field types and edit checks set on each field. Protocol amendments go in during the study with no data loss, and once our team switches on API access, your developers push and pull data from other systems through the REST API. For your next study, you can import a study you have run before and start from its forms.
Keep reading
Can you switch to an EDC mid-study?
Yes. Plan a cut-over date and migrate or freeze the existing data. If your protocol or ethics approval names the data system, file an amendment first.
Is Excel compliant with 21 CFR Part 11?
A plain spreadsheet lacks audit trails, access controls and electronic signatures, so it does not meet Part 11 on its own.
How long does a migration take?
The build takes days to weeks. The data cleaning takes longer and depends on how consistent the spreadsheet is.