Protocol to study build

Visits, forms and fields drafted from a protocol's schedule of activities.

Upload a protocol as DOCX, PDF (with text, not a scan), XLSX or CSV. The portal finds its schedule of activities and proposes a draft study: visits, the forms at each visit and the fields of each form.

How it works

Schedule of activities. The table with visits across, procedures down and X marks. A table split over several pages is joined. Visit names, study days and windows (±3, −2/+5) are read from the header.
Day 1. If the protocol counts the first treatment day as Day 1, days are shifted by one, because the mini-EDC counts the inclusion visit as day 0. The portal warns you about it.
Forms. Each procedure is matched to a standard form in the spirit of CDASH: vital signs, haematology, chemistry, ECG, adverse events, concomitant medications and more. Field codes are CDASH variables (SYSBP, AESTDAT…).
Unknown procedures become empty forms marked “check”. Steps without an eCRF (IxRS registration, sample shipment) get no form.
Logs. Adverse events, medications and procedures go into one unscheduled “Logs” visit, as in the mini-EDC templates.

Complex protocols

Several schedule tables (screening, treatment, follow-up, one per cohort) are read together. Tables that repeat the same visits for another group are flagged.
Cycles (C1D1, C2D8) get study days from the cycle length in the protocol. A repeating visit (“C4D1 and every cycle after”, “every 12 weeks”) is marked “repeats”: on the “Visits” tab, “Add the copies” turns it into separate visits.
Phone and home visits, visits after an event (end of treatment, last dose) are marked from their header.
Footnotes are shown next to the procedure with the kind of condition they set: WOCBP only, pre-dose, time points in the day, fasting.

Not sure where to start? Analyse one of the training protocols on the start page: they are fictional, written for youEDC, and show these cases. Two versions of a protocol can be compared, see “Comparing protocol versions”.

What to do with the draft

Check the “Tree” and “Visits × forms” tabs, fix visits, forms and fields. “Where it came from” shows each procedure's place in the document and its form, which you can change. Every edit goes to “History”, and “Back to the proposal” undoes them.

Download the draft as an Excel specification (visits, forms, fields, matrix, source) or JSON. Creating a mini-EDC study straight from the draft becomes available with the eCRF builder.

No AI, the file is not kept. The analysis follows rules, without language models or outside services. The protocol itself is not stored: the draft keeps its file name, size and SHA-256 checksum so you can see which document it came from.