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About Arun Bhatt Consultant Clinical Research and Development PDF
Clinical trials involve risks to participants that must be carefully understood and managed. Risk assessment involves identifying potential harms, analyzing their probability and severity, and evaluating the risk-benefit ratio. Key risks include those related to the investigational product, trial complexity, and population vulnerability. Risks are mitigated through quality management plans, risk-based monitoring, clear standard operating procedures, oversight of delegated tasks, and targeted training. Effective risk management protects participants and ensures reliable trial results.
Detailed Information
| Author: | ['Anant Khot'] |
|---|---|
| Publication Year: | 2020 |
| Pages: | 38 |
| Language: | English |
| Format: | |
| Price: | FREE |
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