Law No. 214 of 2020 aims to issue a law regulating clinical medical research, to lay the foundations, standards and controls necessary for conducting clinical medical research, and to protect respondents, whether this research is preventive, diagnostic, curative or non-curative, invasive or non-intrusive. Adheres to the provisions of relevant laws, charters and regulations, provided that they are consistent with generally accepted international standards and ethical principles.
Below we review the controls for using a medical organization in medical research in accordance with the law…
The sponsor of medical research may seek the assistance of any of the specialists in the field of medical research or assign a contractual medical research organization, to perform one or more of the medical research obligations or tasks assigned to it, in the manner set out in the executive regulations of this law.
It is worth noting that the law divides clinical research into four stages, the first on a number of people from 20 to 80 people, and the second stage is conducted on a number of people from 200 to 300 respondents who suffer from the disease targeted by clinical medical research, and the third stage is conducted On a group of respondents (patients), their number ranges between hundreds and thousands, and the fourth is known as the post-marketing phase, and it includes the continuous safe monitoring of the drug after obtaining a trading license.