The trial master file: filed once, signed, tracked

Your file

• Every trial keeps a master file. And every document in it has to be findable, current and approved.
• Create the master file for a trial, and MAESTRO builds its structure: 11 zones, 48 sections, and 268 artifacts.
• Choose the study type, and the structure adapts: seventy-seven artifacts change their requirement.

Filing

• File one document at a time, or drop a whole batch into Bulk Upload.
• For each file, AI suggests where it belongs, with a confidence score. Below eighty percent, it is tagged Needs Review.
• Nothing is filed until a person confirms.

Approval

• Then the document moves: request review, request approval, and the approver signs with their password.
• The signature is bound to that exact version and its checksum, so a swapped file is detectable.
• Upload a new version, and it returns to draft. The approved version stays on record.

Oversight

• Document Trackers show the file as a grid: sites across, artifacts down, and a click opens the documents.
• Completeness counts the artifacts that hold an approved or final document. Not-applicable ones are left out.
• Before a document expires, whoever filed it gets a single digest, starting ninety days out.
• And if you allow filing without a second person, a sample of those documents is drawn for a human check.

Site file

• Sites file into their own investigator site file, and see only their own site.
• It is the same document, not a copy. The sponsor sees it as soon as the site files.

The trial master file in MAESTRO: filed once, approved under signature, and tracked until it expires.