Requirements for preclinical and clinical trial norms

Clinical Research Training


Before experiments can be conducted on animals, experiment-specific permission is required from a designated committee or authority. As regulated by different laws regulating preclinical trials across the world, some of the crucial requirements include study rationale, study design, subject eligibility, study treatment, and background of the principal investigator. Generally, an ethics committee is also set up to review and approve the clinical trial prior to its operations commencement. The ethics committee is also responsible for reviewing and approving any changes or updates made to the clinical trial protocols prior to their implementation. However, prior approval from the ethics committee is not required when the implementation of updates is necessary for patients' health and safety.

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