Traceability in Clinical Trials: Challenges of the new EU TMF/eTMF Guideline

Since June 2019, a new EU Guideline on paper and electronic Trial Master File (TMF) is in effect. The Guideline offers clarifications in many aspects. For example, the requirements on electronic TMFs (eTMFs) are clearly stipulated and the essential documents listed in ICH-GCP are supplemented by additional important documents. Emphasis is given to the interface between sponsors and CROs by providing many elements that should be present in either contractual agreements or other documents that describe the cooperation between the parties.