How to Manage the Trial Master File of a Clinical Trial
An underestimated business
Actelion Pharmaceuticals Ltd., Allschwil (Switzerland)
A successful organization of the Trial Master File (TMF) can only be ensured through an excellent filing system and well trained employees. Only an easy access to all filed documents, especially in case of audits or inspections, may conclude a professional system. Conditions for a good working system are standardized processes and tables of content. The following guidelines may support the daily management of the TMF.