Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 73

1 Competent authorities prefer to have at least ten points of contact should there need to be communications between they and the sponsor about some aspect of a clinical trial. True or False?

2 The ICH E6(R2) Guideline calls for records of meeting and other relevant communications about a clinical trial to be maintained in section 5 6 8 9 (Circle the correct section)

3 Regulatory authorities support and encourage meetings to discuss issues which arise with clinical investigations. The US FDA reserves every Friday for such meetings. True or False?

4 Face‐to‐face meetings are a sound approach to discussing/communicating aspects of the conduct of a clinical trial with a regulatory authority. Such meetings also can build __?___ between the parties.

5 Nonconformance with GCP can be a rationale for placing a clinical trial or an investigational application on hold. True or False?