# Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers:  Guidance for Institutional Review Boards, Investigators, and Sponsors - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/use-of-electronic-informed-consent-in-clinical-investigations-questions-and-answers-guidance-for-institutional-review-boards-investigators-and-sponsors/86634097-60db-4d53-bf74-1518a536d9df

> FDA guidance document: Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers:  Guidance for Institutional Review Boards, Investigators, and Sponsors. Issue date: December 15, 2016. Get complete insights and analysis.

---

## Details

- Title: Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers:  Guidance for Institutional Review Boards, Investigators, and Sponsors
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2016-12-15
- Last Changed: 2021-01-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-0390">FDA-2015-D-0390</a>

## Related Documents

- [Digital Health Technologies for Remote Data Acquisition in Clinical Investigations](https://www.globalkeysolutions.net/guidances/guidance-document/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations/d03b5a1b-cf30-4bed-81a8-aa883ea62d4c)
- [A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/a-risk-based-approach-to-monitoring-of-clinical-investigations-questions-and-answers-guidance-for-industry/3134187f-5a62-4b96-8e62-23b17474de42)
- [Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-electronic-health-record-data-in-clinical-investigations-guidance-for-industry/165621f1-dbb5-4b0f-a30a-c5d0ea2e7d02)
