| | Scope | Document part | Language | Document |
|---|
| EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 | G | A4.13 | EN | EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 |
| GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - | G | - | EN | GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 |
| GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security | G | System Security | EN | GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 |
| GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 - | G | - | EN | GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8 | G | III. Annex 1
4.3.8 | EN | ICH ICH E6 Guideline R3 (2025) |
| USA 21 CFR Part 11 09-Apr-2025 § 11.300 | G | § 11.300 | EN | USA 21 CFR Part 11 09-Apr-2025 |
| USA 45 CFR Part 160 09-Apr-2025 - | G | - | EN | USA 45 CFR Part 160 09-Apr-2025 |
