Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 34

1 The regulatory matrix outlined in this chapter includes: Select all that apply____________ Regulatory authorities____________ Local Law enforcement organizations____________ Organizations that license/credential medical professionals____________ Standard setting organizations, e.g. ANSI____________ Academic Medical Institutions

2 Regulatory authorities create, publish, and enforce codes or requirements governing the conduct of clinical trials. True or False?

3 If a physician in the United States or an European Union member state was advertising for subjects to participate in a clinical research trial of an unapproved product without the approval of the regulatory authority what scenario do you think might occur once the regulatory authority (FDA or EMA) was alerted to the situation? (Brief narrative)

4 A physician practicing at an AMC decides to participate in a clinical trial. Do you think the trial protocol and/physician will need to obtain any internal approvals as well as external approvals for permission to participate? Who might be the first to act if it is found that the trial is being performed in nonconformance with GCP?

5 ICH E6(R2) E6 is considered a Guideline. True or False?