Safety in
Clinical Trials
Safety of Clinical Trials
Safety of Clinical Trials Safety of Clinical Trials Safety of Clinical Trials
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As mentioned previously, clinical trials require a vast amount of preparation before it can begin looking for participants. In this section we will explain how clinical trials are regulated to ensure the safety of all of its participants. We will go over the role of ethics committees, Good Clinical Practice (GCP) guidelines and regulatory agencies in the development and running of a clinical trial.

In 1997, country specific Good Clinical Practices guidelines were harmonized into a global entity: International Committee on Harmonization of Good Clinical Practices (ICH-GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Quality assurance and inspections ensure that these standards are achieved.
These guidelines include protection of human rights for the volunteers participating in a clinical trial and provides assurance of the safety and efficacy of the medication.
In summary, they look after the patient’s safety and wellbeing and establish this as the main priority, over the study’s objectives.

