The first in a newly revised series aimed at clinical research professionals, this book is written as a reference for what occurs at the study site, in particular, a reference not only for the new study coordinator but also for experienced coordinators. We have provided a regulatory framework with helpful tips on how to accomplish the clinical research process at the site with the regulations in mind. We are sure we have not anticipated every circumstance, but we hope that this book will provide information to solve most problems.

作为针对临床研究专业人士的最新修订系列的第一本书，本书是为研究现场发生的情况编写的参考资料，特别是不仅为新的研究协调员，也为经验丰富的协调员提供参考。我们已经提供了一个监管框架，并提供了一些有用的提示，说明如何在考虑到监管的情况下完成临床研究过程。我们确信我们并没有预料到每一种情况，但我们希望这本书能提供解决大多数问题的信息。