Study Conduct – Tasks during the Study

  1. Quality control
  2. Project management in order to assure oversight over the study, especially in multicentre studies (Sponsor Oversight)
  3. Product safety reports for obligatory events to all investigators, ethics commitees and authorities
  4. Data management (data cleaning and query management)
  5. Periodical report of study progress to authorities and ethics commitees
  6. Maintenance of the Trial Master File (TMF)
  7. Assure availability of all necessary files in case of governmental inspections
    • System inspection – quality management system is affected
    • Study inspection – study documents are affected