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- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO) +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7. +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5) +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.50 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 +
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.40 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.45 +
- Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C. +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sub-Investigator +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator +
