Data Monitoring Committees (DMCs)
portes grátis
Data Monitoring Committees (DMCs)
Past, Present, and Future
Kerr, David; Rawat, Nand Kishore
Springer International Publishing AG
06/2024
111
Mole
9783031287626
15 a 20 dias
Descrição não disponível.
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.
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Clinical Trials drug approval;Clinical trials vaccine approval;FDA drug approval;unbiased review of clinical trials;statistical analysis of clinical trials data
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
