ABSTRACT
In previous chapters, protocol development (Chapter 4), data management (Chapter 5), investigational agent (Chapter 6), and selecting the investigational site (Chapter 7) have been discussed. In addition to these activities, the Clinical Research Associate (CRA) must coordinate additional aspects to get the study started. The Food and Drug Administration (FDA) requires (21 CFR 312.53) that each investigator submit specified documents. Such required documents are often referred to as “regulatory documents” and must be collected and found to be in good order before the site is permitted to begin the clinical trial. The investigational agent must be shipped to the investigative site and an accurate inventory must be performed. Contracts must be finalized. Institutional Review Board (IRB) approval must be obtained, with documentary evidence of that approval submitted to the study sponsor. This chapter will further discuss these activities.
