1. 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 Available at: Accessed on February 27, 2007