Data Monitoring Committees (DMCs) Past, Present, and Future
tarafından
 
Rawat, Nand Kishore. editor.

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.

Konu Terimleri
Pharmacology.
 
Medical sciences.
 
Drug development.
 
Medicine -- Research.
 
Biology -- Research.
 
Pharmaceutical chemistry.
 
Biometry.
 
Toxicology.
 
Preclinical Research.
 
Biomedical Research.
 
Pharmaceutics.
 
Biostatistics.
 
Medical Toxicology.

Yazar Ek Girişi
Rawat, Nand Kishore.
 
Kerr, David.

Tüzel Kişi Ek Girişi
SpringerLink (Online service)

Elektronik Erişim
https://doi.org/10.1007/978-3-031-28760-2


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