This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies.
Regulatory guidances (draft and/or final ) are subject to revisions.
Therefore, users of the guidances are advised to consult the original website to check for the latest version.
The randomization is discussed in: The European Network for Health Technology Assessment (EUnetHTA) supports collaboration between several European HTA organizations.
EUnetHTA Guidelines have been developed to help the assessors of evidence to process, analyse and interpret the data.