The ICF Generator (from a PDF)

Upload an existing protocol PDF and let Trelice draft a consent form from it.

Sometimes the protocol was not written in Trelice — it exists only as a PDF from a partner, a CRO, or an older system. The ICF Generator takes that PDF and drafts an informed consent form from it. You upload the file, Trelice reads it, and a few moments later you have a consent form you can edit, review, and export like any other.

Who can use it#

Uploading a PDF and generating a consent form is limited to these roles: System Admin, Sponsor Admin, Medical Writer, and Regulatory Affairs. Anyone who is signed in can view the lists of past uploads and generated forms. If the upload area rejects your action, your role is likely a different one — see Roles and permissions.

Opening the generator#

1. In the menu on the left side of the screen, click ICF Generator.
2. What you'll see: a page titled PDF to ICF Generator, with the subtitle "Upload a protocol PDF, extract content, and generate an Informed Consent Form". The page has three parts, top to bottom: an upload card, a generation card (hidden until a file is ready), and a history table.

Step 1 — Upload the protocol PDF#

The card at the top is titled Upload a Protocol PDF. Inside it is a large dashed rectangle that reads Drag and drop a PDF here, or click to browse, with the note Only .pdf files are accepted.

1. Drag the protocol PDF from your computer onto the rectangle — or click the rectangle and choose the file in the window that opens.
2. What you'll see: the text changes to Uploading..., then the rectangle is replaced by a card showing your file's name, its size, and a status badge.
3. Wait for the badge to read COMPLETED. That means Trelice has finished reading the text out of your PDF.

Troubleshooting: If the badge reads FAILED, a red box explains why — most often the PDF is a scanned image with no selectable text, or the file is protected. Trelice needs a PDF whose text can be selected and copied. If you picked the wrong file, click Change to start over.

Step 2 — Generate the consent form#

Once extraction succeeds, a second card appears: Generate Informed Consent Form.

1. In the box labeled ICF Title *, type a name for the consent form — for example "Informed Consent for Study XYZ". This field is required.
2. Under Region, choose USA, EU, or Global. The region decides which regulatory sections the form includes.
3. Under Version Number, keep the suggested "1.0" or type your own.
4. Click the Generate ICF button.
5. What you'll see: the button shows a spinner and reads Generating.... This step uses AI to read the extracted protocol text and draft every consent form section, so it can take a little while. When it finishes, the consent form editor opens automatically.

Editing the result#

The generated form opens in the same consent form editor described in The master consent form — the same sections, the same reading-level badge, the same section review, and the same PDF and Word export buttons.

There are two small differences, because this form has no linked protocol in Trelice:

• A purple banner at the top reads Generated from PDF: followed by your file's name, so everyone knows where the content came from.
• The breadcrumb at the top-left leads back to ICF Generator instead of to a study and protocol.

Everything else works the same, including translations — see Translations and country versions.

Note: AI drafts are a starting point, never a finished document. Read every section against the source protocol before sending anything for review. The reading-level check applies here too: a drafted section above the target grade must be rewritten or regenerated before it can be submitted.

Your history: uploads and generated forms#

The table at the bottom of the page has two tabs:

• Uploads — every PDF you and your colleagues have uploaded, with its filename, size, status, and date. The trash-can button at the end of a row deletes an upload you no longer need. If the list is empty it reads "No uploads yet. Upload a protocol PDF above to get started."
• Generated ICFs — every consent form created from a PDF, with its title, region, status, source PDF, and date. Click Open at the end of a row to continue working on a form. Click any column heading to sort the table.

Note: Deleting an upload removes only the stored PDF and its extracted text. Consent forms already generated from it are separate documents and are not deleted.