25 important definitions of the “Clinical Trials” Law … Know the details

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The draft law on the regulation of clinical medical research, known as “clinical trials,” which was finally approved by the House of Representatives at the last of its fifth session, made about 25 important definitions in the first article, and its text came in the application of the provisions of this law. The following words and phrases mean the meaning indicated next to each Of which:

1- Preclinical research: research that is conducted in an early experimental stage that precedes human experience, and aims to determine degrees of safety and effectiveness of the medical intervention to be studied, and it is carried out through laboratory tests or the use of experimental animals, in accordance with international standards established in pre-clinical research

2- Clinical research: studies or experiments that are conducted on human volunteers to assess the safety and efficiency of any therapeutic, medicinal, surgical, nutritional, preventive or diagnostic interventions, with the aim of reaching scientific, preventive, diagnostic or treatment discoveries of diseases, as well as studies that are conducted to explore the data Volunteer Medicines for a questionnaire for a retrospective evaluation of the effect of a drug, behavior, or surgical intervention, in accordance with internationally recognized ethical standards for research.

3- Good medical practice: A set of internationally and locally recognized principles and standards that are applied in the matter of planning, managing, executing, monitoring, auditing, recording, analyzing, and reporting medical research, with the aim of providing confidence in the reliability and accuracy of the data and announced results of the research, and the preservation of the safety of the respondents. Volunteers, their rights and the confidentiality of their data from any harm

4- Interventional medical research: a study in which a respondent is included to receive a medical intervention with the aim of evaluating the effects of this intervention on medical outcomes in terms of efficacy and safety.

5- Non-invasive medical research: the study in which a respondent is included for his observation with the intention of collecting information about an approved medical intervention or health data about it.

6- Research or medical intervention: the focus of clinical medical study, and includes medical interventions such as medicines, medical devices, vaccines, interventional procedures on the human body, and other products that are a field for testing or are already available, and this research intervention may also include means that do not interfere with the body People, such as health surveys, education and questionnaires

7- Research plan (protocol): The document that includes a detailed explanation of the medical research plan and the information related to it that has been carried out according to the procedures stipulated in this law, reviewed and approved in accordance with

8- Researcher: A person who is qualified doctors, pharmacists, scientists, nurses, or others who work in the field of medical research, and within a research agency undertakes the implementation of the research plan work according to the principal investigator’s instructions and directives

9- Principal Investigator: A person qualified in the field of clinical medical research, and responsible for the research scheme and its implementation, as well as its funding in the absence of a sponsor for medical research.

10- Assistant Principal Investigator: A person who is qualified with the same qualification as the principal investigator, chosen by the latter to carry out some of his tasks and under his supervision, and takes his place if he is absent or unable to continue performing his duties

11- Research team: A group of qualified researchers who work in the field of medical research, and who participate in research work by virtue of their qualifications or experience.

12 – The respondent: The person who conducts medical research and participates in it, whether he is sick or healthy, and whether he is the subject of medical intervention, or he is in a control group, and all this is provided that he initially obtains his informed consent

13- Control group: A group of respondents does not receive the medical intervention under test, but rather gets what is called a placebo (placebo) or standard treatment, in order to compare and measure the effect of the new intervention.

14- Placebo (PLACEBO14) – an inert product that has no therapeutic effect, and is completely similar in morphology to the preparation in question, and does not contain the active ingredient

15- Categories eligible for additional protection: The respondents are most affected by coercion or exploitation, due to the restriction of their will to give informed consent due to lack of or lack of eligibility, cognitive impairment or health status.

16- The legal representative: whoever acts on behalf of the respondent from among the categories eligible for additional protection, as indicated in Article No. (15), regarding giving informed consent to conduct medical research.

17- Human samples: It includes all biological materials of human origin, including organs, tissues, body fluids, teeth, hair, nails, etc., as well as tissues developed from cells isolated from the human body, as well as materials extracted from the cell such as nucleic acids, ribosomes and others.

18- Research organization: The body in which medical research is conducted, and registered with the Supreme Council, according to what is indicated by the executive regulations of this law

19- The sponsor of the research: Whoever assumes the responsibility of initiating, managing, financing and supervising medical research, whether it is a natural person such as the principal investigator, or a legal person such as a company, institution, or local, regional or international organization, provided that it is legally represented within the Arab Republic of Egypt.

20- Contract medical research organizations: legal persons that take the form of an organization, office, or company and are registered with the Supreme Council, authorized to pursue medical research, and with which the study sponsor contracts to perform any of the duties or tasks of medical research entrusted to him, as well as subject in its work in This matter is periodically monitored by the Supreme Council.

21-Informed consent: the written expression based on free and fully voluntary will, which is issued by the person with full capacity and includes his explicit consent, a signature and a fingerprint to participate in clinical medical research after being informed and envisaged in all aspects of this research, and in particular the potential effects or dangers that may affect his decision to participate This approval shall be issued by his legal representative in the cases referred to in the provisions of this law.

22- Side effects: Any minor medically undesirable effects that occur on the respondent while using the research intervention on him.

23- Serious side effects: The effects that arise on the respondent due to the use of the research intervention on him, and they result in serious harm to him or his life is endangered.

24- The Institutional Committee for the Review of Medical Research Ethics: A group of persons with medical and non-medical specialties, who reviews research plans (protocols), and applies the ethical principles to be followed in this regard, and the headquarters of the research body, and this committee is required to be registered with the Supreme Council, and referred to In this law the institutional committee

25 – The Supreme Council for the Review of the Ethics of Clinical Medical Research: The council that is made up of a group of people in medical and non-medical specialties and is charged with setting general policies for conducting medical research and following up on its implementation.

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