EMA
- ICH reflection paper – proposed ICH guideline work to advance Patient Focused Drug Development (PFDD) – Guideline on computerised systems and electronic data in clinical trials – June 2021 – https://www.ema.europa.eu/en/documents/scientific-guideline/ich-reflection-paper-proposed-ich-guideline-work-advance-patient-focused-drug-development-pfdd_en.pdf
- Guideline on computerised systems and electronic data in 5 clinical trials – June 2021 – https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-computerised-systems-electronic-data-clinical-trials_en.pdf