Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (FDA guidance)

Context and history

FDA issued this final guidance in October 2024, in question and answer form. It gives recommendations on using electronic systems, records and signatures in clinical investigations, building on Part 11 and reflecting cloud services and digital tools.

Who and what it applies to

Sponsors, clinical investigators, institutional review boards, contract research organisations and others involved in clinical investigations of medical products, foods, tobacco products and new animal drugs.

What it contains

A Electronic records

Real-world data sources, foreign sites, certified copies, retention and electronic communications.

B Electronic systems of regulated entities

Risk-based validation, FDA's inspection focus for sponsors and investigators, sponsor audit reports, security safeguards, audit trails, date and time controls, and training.

C IT service providers

What to include in agreements, how to show services meet requirements, and whether FDA inspects such providers.

D Digital health technologies

Recording data from participants, attribution, data transfer, and where source data are held.

E Electronic signatures

Valid methods, signatures drawn on screen, identity checks, biometrics and whether FDA certifies systems.

Key points

• Validation should be risk-based.
• Agreements with IT service providers matter.
• Audit trails need not record every keystroke: see Q13 for FDA's view.
• FDA addresses where source data sit when digital health technologies are used.
• It deals with Part 11 for clinical investigations.

In practice

General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.

• Use its list of questions to test your clinical system controls.
• Check that your agreements with IT providers cover what Q17 and Q18 discuss.

Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.