About this document
Ethical Standards in Clinical Trials by Sibu Sah is a document available to read on EtoBox.
The document outlines the principles and guidelines of the ICH-GCP, emphasizing the ethical conduct of clinical trials, the importance of participant safety, and data integrity. It details the roles of various stakeholders, including ethics committees and sponsors, in ensuring compliance with regulatory standards, as well as the key components of clinical trial protocols and monitoring processes. Additionally, it discusses recent amendments to Schedule Y, which enhance ethical oversight and regulatory contr
- Author
- Sibu Sah
- Language
- EN