ABSTRACT
THE ROLE OF THE CRA IN INDIVIDUAL SITE RISK ASSESSMENT
Just as the project manager takes a strategic macro-risk management approach with respect to the clinical trial project, so CRAs can develop an equivalent micro-strategy for each investigational site involved in the trial. The CRA has the opportunity of accomplishing this by frequent contact with the site throughout the project. The risk management mentality can be adopted from day one during initial assessment of the suitability of the site, continuing throughout the trial and beyond the point when the site has been closed, not ceasing until all data queries have been satisfactorily resolved.
