New template – Compliance with applicable rules for biological samples
The form may be used by Sponsors of clinical trials in the Part II application dossier to provide information about “compliance with the applicable rules for the collection, storage and future use of biological samples from clinical trial subjects” (Regulation (EU) No 536/2014, Article 7.1 (h)).
Read the news announcement published by the European Commission on 1st February 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (15 mars 2022). New template – Compliance with applicable rules for biological samples. ELSIBI. Consulté le 17 février 2026 à l’adresse https://doi.org/10.58079/o5wu





