# A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers:  Guidance for Industry - FDA Guidance Document

Source: 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

> FDA guidance document: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers:  Guidance for Industry. Issue date: April 12, 2023. Get complete insights and analysis.

---

## Details

- Title: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers:  Guidance for Industry
- 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: 2023-04-12
- Last Changed: 2024-11-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-0362">FDA-2019-D-0362</a>

## Related Documents

- [Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/expanded-access-to-investigational-drugs-for-treatment-use-questions-and-answers/9bb69e41-e105-4381-9ff7-898811ff1b7c)
- [Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier](https://www.globalkeysolutions.net/guidances/guidance-document/grandfathering-policy-for-packages-and-homogenous-cases-of-product-without-a-product-identifier/6ebf451c-99b2-45bb-bcb8-31ab0526d0ca)
- [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)
