Data Monitoring Committees (DMCs) Past, Present, and Future
by
Rawat, Nand Kishore. editor.
Title
:
Data Monitoring Committees (DMCs) Past, Present, and Future
Author
:
Rawat, Nand Kishore. editor.
ISBN
:
9783031287602
Edition
:
1st ed. 2023.
Physical Description
:
XII, 111 p. 1 illus. online resource.
Contents
:
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.
Subject Term
:
Pharmacology.
Medical sciences.
Drug development.
Medicine -- Research.
Biology -- Research.
Pharmaceutical chemistry.
Biometry.
Toxicology.
Preclinical Research.
Biomedical Research.
Pharmaceutics.
Biostatistics.
Medical Toxicology.
Added Author
:
Rawat, Nand Kishore.
Kerr, David.
Added Corporate Author
:
SpringerLink (Online service)
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 527831-1001 | ONLINE | | Elektronik Kütüphane |