There are different types of quality checks performed on TMF content. Uploaders should perform a record quality check prior to uploading a record. Records should go through some type of quality check (QC) workflow post upload. Additionally, there should be periodic risk based completeness checks of the TMF through-out the life of the study. Finally, […]
The Trial Master File (TMF) tells the story of a study through all phases of drug development. The documentation filed gives evidence that the trial was conducted in accordance with standards of Good Clinical Practice (GCP) and regulatory expectations. This story becomes the cornerstone of inspection readiness. The purpose of a regulatory inspection is to […]
