(EU: Reg. 536/2014 – GCP guidelines)
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guideline_adopted_1_en_act_part1_v3.pdf
(EMA: Functional specifications for the EU portal and EU database to be audited)
https://www.ema.europa.eu/en/documents/other/functional-specifications-european-union-eu-portal-eu-database-be-audited_en.pdf
(Article - Main changes in European Clinical Trials Regulation (No 536/2014))
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039537/pdf/main.pdf