All SOPs are included into Appendices to the Statutes on the Committee, which constitute the integral part of this Regulation.
1.
Requirements to presentation of a file and application procedure.
2.
Preliminary expert examination of documents and materials.
3.
Meetings of the Independent Interdisciplinary Committee. Ethical review procedure. Decision making procedure. Procedure of notification of the applicants about the decisions. Execution of findings.
4.
Requirements to patients’ informed consent.
5.
Ethical support, monitoring and further supervision and examination of materials of authorized clinical trial.
6.
Documentation and archiving of materials of clinical trial.
7.
Confidentiality undertaking.
8.
Presentation of candidates to members of the Independent Interdisciplinary Committee for ethical expert evaluation of clinical trials, approval of members of the Committee, changing of members of the Committee.
9.
Procedure of examination of issues with regard to sponsorship of studies.
10.
Procedure of inclusion into the study of a patient unable to acknowledge information and make a decision regarding participation in the study, in the absence of a legal representative.
11.
Measures to ensure quality of the Committee’s activities. Procedure for self-assessment and quality audit of the Committee’s activities.
