Controls and rules for researchers in the law regulating clinical research that must be adhered to

Law No. 214 of 2020 on the regulation of clinical medical research until 2022 stipulated many controls and rules that regulate the work of researchers in the law, as the provisions of this law are aimed at establishing the foundations, standards and controls necessary for conducting clinical medical research, and protecting the respondents, whether this research is preventive. Diagnostic, curative or non-curative.

The principal investigator and the study sponsor, if any, shall abide by the following:

1. Recording and keeping all information, data and reports related to medical research, and verifying their validity and accuracy.

2. Making all information, data and reports related to medical research available during the research or following its completion to each of the competent institutional committee, the Supreme Council, the General Intelligence Service and the Egyptian Medicines Authority, for the purpose of auditing and review.

3. Not to publish or advertise in newspapers or the media any information, data or reports regarding the medical research, except following its completion and obtaining for this purpose a written approval from the competent institutional committee and the Supreme Council, and the written approval of the participating respondents in the event of disclosing any statement or information regarding them.

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