Departement of Epidemiology, Biostatics and Health Data
This department comprises two complementary teams:
•The DATA Management team, which guarantees the quality, reliability, security and retention of data from the studies sponsored by the Antoine Lacassagne Center.
•The methodologists and biostatisticians team who ensure the choice and design of the study design, statistical analyses and assistance with publication.
Its missions are related to biostatistics and data management:
• Provide advice and methodological expertise to doctors and researchers
• Development of the methodology of clinical and epidemiological research projects
• Drafting of a statistical analysis plan meeting the objectives of the study
• Writing case report forms with the investigating physicians
• Design of databases
• Development of electronic case report forms (e-CRF)
• Randomisation (by list, by minimisation, with or without stratification)
• Secured access control to the e-CRF
• Data verification (consistency test settings, issue of correction requests)
• Coding of adverse events and history with the MedDRA dictionary
• Import of external data
• Export of data according to CDISC standards
• Participation in coordination committees and management of case reviews
• Statistical analysis of data
• Writing of the end-of-study statistical report
• Freezing and archiving of studies
• Participation in the promotion of research projects (communications, publications, patents)
It participates in the improvement of data to obtain high-quality results and ensures the information and training of doctors/healthcare professionals carrying out research projects internally or trial clinical research investigators.