We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » EMA Publishes Draft Guideline on Complying with Clinical Trial Master File Requirements
EMA Publishes Draft Guideline on Complying with Clinical Trial Master File Requirements
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines.