Article 40. Procedure for Clinical Trial of Medicinal Product for Medical use

1. The head of the medical institution conducting a clinical trial of a medicinal product for medical use shall appoint an investigator responsible for the clinical trial of the medicinal product for medical use, which investigator shall have a medical qualification corresponding to the clinical trial of the medicinal product to be conducted, with at least five-year experience on programs of clinical trials of medicinal products, and at his/her suggestion appoint fellow investigators from among of the physicians of this medical institution.

2. The investigator shall select patients who may be enrolled in the clinical trials of that medicinal product for medical use based on the medical indications.

3. The investigator and co- investigators shall be familiarized with the results of the non-clinical trial of the medicine contained in the investigator’s brochure, a clinical trial draft protocol of the medicinal product for medical use prepared by the developer of the medicinal product or any other legal entity engaged in organization of the clinical trial of the medicinal product for medical use, and with other materials of the clinical trial.

3¹. Within not later than three business days on the start of the clinical trial of a medicinal product for medical use the head of the medical institution shall notify the the authorized federal executive body, which issued the permit to conduct such clinical trial about this according to the prescribed form.
(clause 3¹ introduced amended by Federal Law of November 29, 2010, No. 313-FZ)

4. The institutions that organize a clinical trial of the medicinal product for medical use and referred to in Clause 3, Article 38 of this Federal Law, shall, if the draft protocol of the clinical trial of the medicinal product for medical use needs to be amended, notify the authorized federal executive body, which issued the permit to conduct such clinical trial, according to the prescribed form.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

4¹. The form of notice of on amending the protocol of the clinical trial of the medicinal product for medical use should contain the following data:

1) the name, ID number and the date of the protocol of the clinical trial;
2) the date of amendments to the protocol of the clinical trial;
3) the name and location of the applicant;
4) the name of organization involved by the developer of the medicinal product for medical use to arrange the conducting of the clinical trial (if any);
5) the names and locations of medical center for conducting of the clinical trial of the medicinal product  for medical use;
6) date of issue of permit for the conduct of the clinical trial and the number of the permit;
7) the amendments to the protocol of the clinical trial.
(clause 4¹ introduced by Federal Laws of October 11, 2010, No. 271-FZ)

5. Within thirty business days of receipt of the notice referred to in Clause 4 of this Article, the authorized federal executive body shall review this notice in the procedure which has established and make a decision on amending the draft protocol of the clinical trial of the medicinal product for medical use or on rejection of such amendment.

6. A clinical trial of a medicinal product for medical use may be suspended or terminated if proving a danger to the patients' health and life while in progress. In the event of a danger to the life or health of the patient involved in the clinical trial of a medicinal product for medical use, the investigators shall notify the head of the medical institution and/or the institution, which obtained a permit from the authorized federal executive body to organize a clinical trial of the medicinal product. A decision to suspend a clinical trial of a medicinal product for medical use shall be made by the head of the medical institution and/or the institution, which obtained a permit from the authorized federal executive body to organize a clinical trial of the medicinal product. A decision on termination of such trial shall be made by the authorized federal executive body on the basis of the written notice received form the head of the medical institution or institution, which obtained a permit from the authorized federal executive body to organize a clinical trial of the medicinal product for medical use.

7. Within not later than five business days on completion, suspension or termination of the clinical trial of the medicinal product for medical use, the notice of the same shall be forwarded to the institutions refereed to in Clause 3, Article 38 of this Federal Law, and to the authorized federal executive body according to the prescribed form.

8. The form of notice of completion, suspension or termination of the clinical trial of the medicinal product for medical use shall include:

1) information about the medical institution(s) which has/have conducted this trial;
2) trial description;
3) investigator’s details (full name, place or employment, position, qualification, experience on programs of clinical trials of medicinal products, and list of clinical trials of medicinal products in which he/she participated (when) as an investigator or a co-investigator);
(as amended by Federal Law of October 11, 2010, No. 271-FZ)
4) trial results (trial completion/suspension/termination indicating their reasons and the effect on the reasons on the results assessment, risk assessment and anticipated benefit from the use of the medicinal product under investigation, as well as further supposed actions).

9. The authorized federal executive body shall publish and place on its official website a notice of completion, suspension or termination of the clinical trial of the medicinal product for medical use within five business days on its duly receipt.

10. The authorized federal executive body shall maintain a register of investigators who are conducting or conducted clinical trials of medicinal products for medical use in accordance with the rules approved by such body and duly place the register on its official web-site. Such register shall contain data as provided for in Sub-clause 3 of Clause 8 of this Article.

11. The institution mentioned in Clause 3 of Article 38 of this Federal Law shall prepare a report on the findings of clinical trial of a medicinal product for medical use on the basis of conclusions of the medical institutions involved in this trial, and submit it to the authorized federal executive body, which issued a permit to conduct the trial, within three months on the trial completion, suspension or termination in accordance with the procedure established by the authorized federal executive body.

12. Failure to follow good clinical practice, falsification of clinical trial results of a medicinal product for medical use shall entail liability as prescribed by the laws of the Russian Federation.

13. When conducting a clinical trial of a medicinal product for medical use, biological sampling in patients is permitted (biologic fluids, tissues, secretion and waste products, physiologic and pathologic discharge, smears, scrapes, washouts, microorganisms, bioptic materials) for study of the samples inside and/or outside the Russian Federation

14. The procedure for import into the Russian Federation and export outside the Russian Federation of biological materials obtained in a clinical trial of a medicinal product for medical use shall be established by the Government of the Russian Federation.