Investigator

The investigator (PI) is responsible for all of the site’s data: signs what is complete — a personal act with re-authentication — and sees the audit trail of their data and who has access to the site. The PI can delegate part of these duties — see delegation.

Your day: frequent tasks

• Sign dataApply an electronic signature to a form, a visit or a subject's whole casebook — with a coverage preview and re-authentication — and re-sign after invalidation.
• Export dataRun an export on the Exports screen — CDISC ODM 1.3.2, CDISC tabular datasets or a core snapshot — and download the file with its SHA-256 checksum.

Good to know

• Electronic signatures and Part 11 — what a signature means and when it is invalidated.
• Segregation of duties and delegation — what can be delegated to the team.
• Audit trail — your site’s data history.