Electronic Trial Master Files
Equipped with DIA TMF Reference Model and the KHP-CTO Investigator Site File Review Checklist embedded, the system classifies, stores, manages and maintains all trial master files in a central “location” where access to the files is full controlled. User can create a folder, drag/drop files, search, review and comment files and setup access restrictions in the system. The system can display the status (“missing”, “ongoing”, “final”) at folder or file level. At the time of trial closeout, the system will pack the eTMF for regulatory submission or archive.