ABSTRACT
Before data can be entered from a traditional paper case report form (CRF) into a database, that central database and the associated entry screens have to be created. Before data can be entered into an electronic data capture (EDC) system, that system must be built and deployed to the sites. In both cases, because the database is used to create electronic records subject to 21 CFR (Code of Federal Regulations) Part 11, the systems must be tested to demonstrate accurate storage and reliable behavior. In this chapter, we will look at the steps required to build the database, which has been speci—ed according to guidelines in Chapters 2 and 3, and release it to receive data.
