Avoid Critical Findings in Your TMF - A Review of MHRA Findings
In clinical research, there is great emphasis on the TMF being
inspection-ready at all times. However, regulatory agencies still encounter critical findings in the TMF during inspection. The MHRA recently published their annual GCP Inspections Metrics Report covering metrics from April 1, 2018, to March 31, 2019, which include what issues were found during inspections. In this white paper, we take a look at the most common TMF issues and how to avoid them.