Voisin Consulting Life Sciences glossary icon
Glossary

eTMF/ TMF: electronic Trial Master File / Trial Master File

Loading..
Click a letter to view all its definitions

Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.

Other glossary definitions

O

Overdose

Administration of a quantity of a medicinal product given per administration or cumulatively which is…

View definition
L

Lay Person Summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of…

View definition