Trials and protocols

Creating trials, uploading protocols, extraction, versions and amendments.

Trial fields

Code, title, phase, sponsor (free text), target enrollment, program, and status: Setup, Recruiting, Paused, Closed or Archived.

Protocol upload and extraction

Files are scanned, stored encrypted, and their text extracted with page, section and character anchors. Scanned-image protocols require OCR Planned · V2.

Versions

Draft — editable.
In review — frozen for authors; comments allowed.
Approved — immutable; usable for cohort discovery.
Superseded — replaced by a later approved version; history retained.

Amendments

A new draft is copied from the approved version, and the diff shows added, removed and changed criteria. Records screened under an earlier version stay pinned to it and are flagged for review.