A Clinical Data Analyst with SAS Programming Sowjanya Ratho, Guenter Tusch, PhD Medical and Bioinformatics Graduate Program, School of Computing and Information Systems, Grand Valley State University, Allendale, MI, USA Database for CDM Oracle Clinical -EDC -Pfizer, Novartis Clintrail -Paper – Pfizer, Sanofi..etc Inform -EDC – Sanofi,GSK Rave (Medidata) - EDC – AZ Pre-Lock Activities Clinical Research Clinical Data Management Data Analysis Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. Clinical Research Departments: Clinical Operations Clinical SAS CDM- clinical data manager PV- pahrmaco visualence MW- medical writing RA- regulart afferies Record Data Management Project Management Quality Management CDM Study Activities using EDC Clinical Data Management is the collection, integration and validation of clinical trial data, it is the process of ensuring that the data collected during a clinical trails Accurate : perfect conformity to fact or truth ; strictly correct Complete : Having every necessary or normal part Logical : Legitimate Consistent : The same, through in structure or composition Lock Activities Lock: When all clinical trial data has been reviewed, queries resolved and issues addressed, the database is closed or locked. The database cannot be changed in any manner after locking – unless an unlock has been performed (not optimum situation). This is how I view soft lock versus hard lock. A soft lock is when data is considered clean and set to read only for all users, whether 'frozen' in EDC or write access is removed on paper studies, so no data can be modified at that point. This is usually done to give the sponsor and/or stas/programming group time to review the final data for any issues prior to locking the database. The soft lock allows them to do this and know that no data will be changed. If they accept the data in its curent state then they can give approval to move to 'hard lock'. Once data is in hard lock, if any issues are identified after that point you need to go through the process of officially unlocking the database and filing the appropriate paperwork according to your company's SOPs. CDM Study Activities using paper-based Discrepancy Management This is the process of identifying and managing potential problems with data collected during a study. Empty fields Unrelated items Incorrect Range Discrete value checks One value greater/less than/equal to another Dates not in logical sequence Any missing visits or pages Visits not in compliance with protocol Inclusion/exclusion criteria not met Lab values not in normal ranges Reference: International Conference on Harmonisation. Guideline for Good Clinical Practice, E3. Geneva, Switzerland: Author; 1996. Woolen S. Office for Good Clinical Practice Web site. October 2001. Available at: http://www.fda.gov/oc/gcp/. Accessed on February 27, 2007