Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 136

In this chapter, you will be introduced to the primary roles and responsibilities of the Regulatory Authority (or Competent Authority) in terms of those functions which are highlighted in the GCP framework. The primary roles, i.e. functions, of the regulator are:

 Reviewing and making decisions on clinical trial applications.

 Oversight and inspection of the other players involved in the clinical trial endeavor to ensure conformance with GCP, investigational plans, and applicable regulations.

As noted in the Players and Interactions topic, the regulator performs these functions through interactions with sponsors, investigator sites, and IRBs/IECs.

In addition, you will gain insight into why the regulator has responsibility for these functions and is therefore accountable for implementing them.