List of documents
The documentation being submitted must include the following:
- Application of the applicant addressed to the Chairman of the Committee identifying the full name of the study protocol, list of documents submitted specifying version numbers and dates.
The letter to the Chairman of the Committee, Volskaya Elena Alekseevna, shall be written on behalf of the applying legal entity and on a headed paper thereof in an optional form. At the core, the letter is an application to the Committee requesting to approve (authorize) conduction of a certain clinical study or a supervision program in the Russian Federation.
Documents from the below mentioned list of documents submitted shall be specified in the numbered appendixes to the application letter. The list of the attached documents is not final, it may be reduced or extended with documents of any significance, at the applicant’s opinion, for conduction of expert evaluation (for example, copy of insurance policy, instruction on taking of a medication). That is also applicable to supplementary information that may be indicated in the letter. For example, information regarding a sponsor, countries and medical centers where this study was done or is expected to be done, number of patients included in the study, period of data collection, a person from the applying organization for contacts from the part of the Committee etc.
- It is desirable to indicate a contact person (for example, the coordinator of the study) for clarification of any issues arising on the part of the Committee.
- Protocol of the clinical study in English and Russian
- Information for patients and the form of written informed consent of the patient in English and Russian (pursuant to the SOP, appendix to Regulation No. 5).
- Case Report Form.
- Diaries, questionnaires to be filled in by patients participating in the study.
- Investigator’s Brochure.
- The list of clinical centers where the study is intended to be done.
- Curriculum vitae (CV) of the investigators signed and dated by the investigator.
- Documents of guarantee to comply with the rights of patients participating in the study in case of damage to their health (insurance certificate or the sponsor’s letter regarding compensation).
- Materials, including advertising, informing about the study and being used for attraction of patients to participate therein.
- Previous decisions of national committees on ethics in respect of this intended study, if any.