Başlık:
Data Monitoring Committees (DMCs) Past, Present, and Future
Yazar:
Rawat, Nand Kishore. editor.
ISBN:
9783031287602
Basım Bilgisi:
1st ed. 2023.
Fiziksel Tanımlama:
XII, 111 p. 1 illus. online resource.
İçerik:
Introduction-.What is a DMC?-. Is a DMC required?-. Who is On the DMC?-. What are the Legal and Ethical Aspects of DMC?-. How does the DMC work with SDAC and Sponsor and External Groups ? -- What Does a DMC Meeting Look Like -- What data is used for DMC outputs and who programs? -- What is Included in DMC Outputs? -- What does the DMC final DMC outputs look like and how is it delivered? -- What Types of Safety Outputs Does the DMC Receive? -- What types of efficacy outputs does the DMC receive? -- What types of other outputs does the DMC receive? -- What About In-Between DMC Meetings -- What types of formal interim analyses does the DMC review? -- What does the paperwork from meetings look like? -- How does the DMC assess risk-benefit for their decision making? -- What are some examples? -- Conclusions.
Tüzel Kişi Ek Girişi:
Elektronik Erişim:
https://doi.org/10.1007/978-3-031-28760-2Kopya: