Improving the quality of clinical trials by applying efficient data management processes

For a clinical trial to be successful, it is necessary to possess high quality data from patients. The Clinical Data Management (CDM) department is the one responsible for that, gathering data and separating it into two groups: CRF (Case Report Form) and non-CRF data. The first one corresponds to data introduced directly by the hospitals into the CRF. The other, to data which cannot be directly loaded into the CRF by them, such as samples that must be analyzed by an external laboratory. The Data Acquisition Specialist (DAS) is the CDM function responsible for the development of specifications, processing and delivery to the study team of all non-CRF types of data. Its duties are very varied, one of the principal being the creation of the File Format Specifications (FFS), a document that details the pertinent terminology and procedures to be employed to import it. Afterwards,incoming data will be checked against the FFS and processed in the internal database for posterior analysis, which will allow medical doctors to extract conclusions about the trial. This thesis has been developed in an internship at the headquarters of Hoffmann-La Roche in Basel, Switzerland, and aims to illustrate the different ways in which an effective data management, performed by a DAS at CDM, can improve the quality of clinical trials. For that, three clinical trials – Morpheus Lung, lung cancer; WP29945, colorectal cancer and Pasadena, Parkinson's disease –in which I have been involved will be detailed, as well as the activities I performed in them. In addition, concepts about Roche and the world of clinical trials will be explained as an introduction.Outgoin