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Sign-off

Approve a document in order, with a signature that records what you meant.

The Chain

The default chain is Team review, QC review, QC changes incorporated and CMO approval. A writer can rename, reorder, add or remove steps and assign a person to each. A step cannot be changed once it is signed.

Signing

  1. Open the document and go to Sign-off.
  2. When it is your turn, choose Sign on your step. Steps go in order, so an earlier step must be signed first.
  3. Read the meaning of the signature, tick to confirm it, and re-enter your password.

Afterwards

A signed step cannot be changed. Once any step is signed the document is read only: text, TFLs, title, title page, settings, reviewer panel, section structure and owners, QC checks, suggestions and redaction decisions are frozen. People can still add and resolve comments. To change a signed document, start a new one for the study. The signature, its meaning, the time and the signer go into the audit trail, and the exported DOCX carries the signature page.