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What happens if the subject experiences serious side effects during the medical research .. Know the procedures

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The Clinical Medical Research Law approved by the President of the Republic specified the measures to be taken in the event that the subject experiences side effects. Article 21 stipulates that the principal investigator, the research sponsor, the research body, the competent institutional committee and the Egyptian Medicines Authority, in the event that the respondent experiences side effects, serious side effects, or damage not anticipated at the time of approval of the protocol or an unpleasant medical practice, shall perform, each as follows: It is his authority to take measures that would suspend or terminate the research, according to each case, provided that the person taking these measures gives immediate written notification to the Supreme Council, and in turn issues the necessary decisions regarding it. The parties referred to in the previous paragraph in writing of these procedures.

Any of these parties may appeal the decision issued by the Supreme Council in this regard

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