eTMF Management Essentials

About This Document

To comply with regulatory requirements pertinent to clinical trials, every organization engaged in a clinical trial must manage and maintain all trial-related content, documents, and data in a manner that not only supports the claims to the safety and efficacy of a product, but that also serves as evidence the trial was conducted in a compliant manner. Depending on the regulatory jurisdiction, this information may be stored in a collection called a trial master file, or TMF, which in today's era of technology and electronic mediums commonly takes the form of an electronic trial master file (eTMF).