title: Results of a quality control on non-interventional studies.
abstract: Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) on the execution of non interventional (observational) studies of 1998 and finally with the guidelines and recommendations for ensuring Good Epidemiological Practice (GEP), with the VFA (Verband der forschenden Arzneimittelhersteller [German Association of Research-Based Pharmaceutical Companies]) - Recommendations for the Improvement of Quality and Transparency of NIS and the joint recommendations of BfArM and PEI (Paul-Ehrlich-Institut) on the execution of NIS, pharmaceutical companies are required to monitor and/or verify quality in the course of a project. According to a survey of pharmaceutical companies 2010, about one third of the companies surveyed to date carry out such quality controls on site, at participating study centres. This report deals with the results of such quality control measures in 4 completed projects. The control rates defined in the respective cohort study plans, the measures carried out on site and any consequent measures, such as adjustment of forms, reduction of consultation time and necessary organisational changes are described. A high level of agreement between the data collected and the original patient documents is found, comparable to that in clinical trials.
authors.affiliation: Sanofi-Aventis Deutschland GmbH, Clinical Study Unit, Frankfurt/Main, Germany. Karl.Woerz@Sanofi-Aventis.com
authors.forename: Karl
authors.initials: K
authors.lastname: Wörz
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Hundt
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D019317:Evidence-Based Medicine / Q000592:standards; D005260:Female; D005858:Germany; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D009103:Multiple Sclerosis / Q000503:physiopathology; D009369:Neoplasms / Q000523:psychology; D011471:Prostatic Neoplasms / Q000188:drug therapy; D011786:Quality Control; D011788:Quality of Life; D012107:Research Design
chemical_list: D007328:Insulin