Effective Clinical Research is first and foremost a science – where the data must be collected in the precise manner described in the protocol pop over to this site.
When trial personnel fail to understand that clinical research is a precise science, data quality suffers. Quality cannot be retro-fitted! A focus on the science of clinical research at the sites is job #1.
Clinical Science Investigation (CSI) is the process of guiding research from Discovery Science (for a new product) through Regulatory Science (embodied in the Regulatory Plan) toward Statistical Science (via the Strategic Statistical Plan). Statistical Science ensures that each trial and each patient meets the requirements of the target regulatory agency (e.g. HC, FDA, EMA)
The final element in the CSI portfolio is the Quality Risk Management Plan as defined in ICH Q9 (1) and nicely elaborated in the EMA, “Reflection Paper on Risk Based Quality Management in Clinical Trials,” draft (2011) (2). The risks associated with each drug development plan, each protocol and each site participating in the clinical trial are documented and quality systems established to manage the risks.
The result is data fit for decision making – should this new discovery be allowed to go to market. After all, it is all about science.
- ICH Q9
- EMA, “Reflection Paper on Risk Based Quality Management in Clinical Trials,” draft (2011)