New Eudralex Vol.10 Guidance
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The EU Commission has published a technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. It It provides a visual representation of the clinical trial results data that is required to be captured by EudraCT. It also provides details of how the fields are organised.
Source: http://ec.europa.eu/health/files/eudralex/vol-10/2013_01_22_tg_en.pdf
Related GMP News
11.12.2025Insurance Review in Phase 1 Clinical Trials
11.12.2025EMA Publishes Comments on ICH E21
27.11.2025Final ICH M14 Guideline on the Use of RWD for Safety Assessment
25.11.2025Clinical Trials: BMG publishes Standard Contractual Clauses Ordinance
04.11.2025UK Clinical Trials Regulations: Six-Month Countdown
04.11.2025Clinical Trials - Update on the CTIS