# Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations:  Questions and Answers - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/electronic-systems-electronic-records-and-electronic-signatures-in-clinical-investigations-questions-and-answers/e5689679-aaef-4ab4-9a7e-d50eaf459dce

> FDA guidance document: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations:  Questions and Answers. Issue date: October 01, 2024. Get complete insights and analysis.

---

## Details

- Title: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations:  Questions and Answers
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-10-01
- Comment Close Date: 2023-05-15
- Last Changed: 2024-10-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-1105">FDA-2017-D-1105</a>

## Related Documents

- [Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/pathology-peer-review-in-nonclinical-toxicology-studies-questions-and-answers/2389b45f-e333-46cf-b87b-a1e55f05c775)
- [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 Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-whole-slide-imaging-in-nonclinical-toxicology-studies-questions-and-answers-guidance-for-industry/fc84d5fe-2f95-4d3c-9001-406c9aa4ef09)