ABSTRACT
The role of QualityAssurance in Drug Development is not readily understood by those in the pharmaceutical industry not directly involved either in Quality Assurance activities themselves, or as a customer or client of Quality Assurance functions. This chapter will discuss the activities that an effective Quality Assurance organization can provide to Clinical Research. Since comprehensive Quality Assurance/Compliance is not normally restricted to Clinical Quality Assurance activities, this chapter will, of necessity, briefly discuss other areas of Quality Assurance/Compliance as well.
