MHRA guidelines on trial master files — where are we one year later? Asks Jennifer Goldsmith, Veeva Systems.
In April 2014, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) updated its definition of a critical GCP inspection finding to include trial master files (TMFs) that were “not readily available or accessible.” The Agency asserted that this change was partly driven by the fact that more than one-third of TMF inspections are delayed due to incomplete or inaccessible files. In response, the global life sciences industry heightened its focus on managing TMF content compliantly as part of a larger movement away from paper to fully electronic trial master files (eTMFs). This drive is bolstered by the increased use of service providers such as contract research organisations (CROs) to support the clinical development process.