TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings May 2018

Course Description

On April 24, 2014, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release indicating that the definition of a critical Good Clinical Practice (GCP) inspection finding had been changed. It now includes, ‘Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.’ Recently, the European Medicines Agency (EMA) released a reflection paper on GCP compliance in relation to TMFs. Currently, the FDA has not released regulatory guidance that directly addresses TMF expectations. FDA’s regulations are general and require that sponsors and investigators maintain adequate and accurate records of any clinical investigations that are carried out. This web seminar will examine these expectations and discuss recent regulatory findings. We will also discuss strategies for implementing corrective and preventive actions (CAPAs) that result in successful outcomes to regulatory findings associated with TMF inspections.

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Learning Objectives

  • Explain regulatory expectations regarding TMF/eTMF management
  • Identify two recent regulatory findings directed at TMF/eTMF management
  • Describe strategies for preparing effective CAPAs that address regulatory findings
  • Discuss plan for preparing for a regulatory inspection

Who Should Attend

  • Good Clinical Practice Auditors and Quality Assurance Directors
  • Trial Master File Directors, Managers, and Coordinators
  • Clinical Operations Directors and Trial Managers
  • Records Management Team Members


Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.