ABSTRACT
The first step in producing a risk assessment is the gathering of information. The objective is to generate a simple list identifying the most likely events which may pose a risk to the trial. This is best achieved by obtaining the opinions of all the project stakeholders, consultants, and functional group representatives (e.g., marketing, data management, biostatistics, etc.). They immediately strengthen the process by conferring both a range of specialist expertise and a variety of perspectives from which to view the issues.
