e8: general considerations for clinical trials

How Are Participants Protected in Clinical Trials?

Participant safety is paramount in clinical trials. Ethical guidelines and regulations are strictly followed to protect participants. Key measures include:
Informed consent: Participants are fully informed about the trial's purpose, procedures, risks, and benefits before agreeing to take part.
Institutional Review Boards (IRBs): These boards review and approve trial protocols to ensure they are ethical and participants' rights are protected.
Continuous monitoring: Trials are monitored by Data and Safety Monitoring Boards (DSMBs) to ensure ongoing safety and efficacy.

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