Trial Master File
The Trial Master File (TMF) is a collection of documents covering all the major files of a clinical study summarized to the integrity of the clinical data and regulatory compliance (Engl. Compliance ) for Good Clinical Practice ( GCP ;. English for Good Clinical Practice ) to ensure.
Clinical studies are an integral part ofobtainingthe approval of innovative drugs or generics , with the requirements for implementation being stipulated by law. The Trial Master File is an essential part of the documentation of a clinical study, the content ofwhich is regulatedin EU Directive 2005/28 / EC . This collection of documents in the TMF enables the implementation of the clinical study and the quality of the data to be assessed. The sponsor of a clinical study creates a Trial Master File and an Investigator Site File . The Trial Master File is kept by the sponsor during the ongoing clinical trial. The Investigator Site File is given to the Investigator by the sponsor and kept in the trial center. In addition to the paper-based Trial Master Files , electronic Trial Master Files ( eTMFs )are also used due to the increasingly complex clinical studies.
The TMF must be kept for at least 5 years after the end of the clinical study, but the period can also be longer (e.g. according to national legislation or if the clinical study is used for marketing approval).
Content of the TMF
With the help of the TMF it can be proven that the study is carried out by the investigators and the sponsor on the basis of Good Clinical Practice. The ICH GCP Guideline from 1996 defines the essential components of the TMF. Among other things, information about the investigator, the study design, information about the investigational medicinal product, the original of the randomization list in a clinical study and financial agreements between the investigator and sponsor are part of the Trial Master File. However, this list only represents the minimum requirements.
Individual evidence
- ↑ a b DIRECTIVE 2005/28 / EC OF THE COMMISSION of April 8, 2005 laying down principles and detailed guidelines of good clinical practice for investigational medicinal products intended for use in humans, as well as requirements for the granting of a license to manufacture or import such products. EMA, accessed April 6, 2015 .
- ↑ a b c Reflection paper on GCP compliance in relation to trial 6 master files (paper and / or electronic) for management, 7 audit and inspection of clinical trials. (pdf) EMA, accessed April 6, 2015 .
- ↑ a b 8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL. ICH GCP, accessed April 6, 2015 .