A clinical trial report is due within no more than 12 months in Russia. What the GCP Rules changed from 10 March 2026
The report on the results of a clinical trial (CT) of a medicinal product is drawn up by the organization that organizes the trial (under Federal Law No. 61-FZ «On the Circulation of Medicines», hereinafter 61-FZ). The report is submitted to the authority that issued the authorization to conduct the trial, within no more than 12 months from the date of completion, suspension or termination of the trial.
The structure and content of the report are determined by the Rules of Good Clinical Practice of the Eurasian Economic Union (hereinafter the GCP Rules), approved by Decision of the Council of the Eurasian Economic Commission (EEC) of 3 November 2016 No. 79. The GCP Rules as amended by Decision of the EEC Council of 1 August 2025 No. 63 (hereinafter Decision No. 63) apply from 10 March 2026.
Who draws up the report and to whom it is submitted
The following are entitled to organize the conduct of a CT: the developer of the medicinal product or a person authorized by the developer, educational organizations of higher education, organizations of additional professional education, and scientific organizations (under 61-FZ). The trial organizer sends a notification of the completion, suspension or termination of the CT to the authorized federal executive authority no later than five working days from the date of the relevant event. Among other things, the notification form contains the result of the trial with the reasons for completion, suspension or termination and their effect on the assessment of results, the overall assessment of the risk and expected benefit of using the product, and the proposed further actions.
The report on the results is submitted separately and in the manner established by the authorized federal executive authority. The commentary by A.N. Borisov on 61-FZ (2nd edition, Yustitsinform, 2026) states that the Russian Ministry of Health adopts this procedure and that there is no information that it has issued one. No act of the Russian Ministry of Health containing this procedure has been found.
The previous version of 61-FZ (of 19 October 2023) provided that the organization draws up the report on the basis of conclusions of the medical organizations that conducted the trial and submits it within no more than three months from the date of completion, suspension or termination of the trial. The version in force from 1 September 2024 contains no reference to conclusions of medical organizations and sets a period of no more than twelve months.
Clinical trials of medicines in the member states of the Eurasian Economic Union are conducted under the rules of good clinical practice approved by the EEC (under the Agreement on Uniform Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union of 23 December 2014, hereinafter the Agreement). Until decisions of the EEC regulating the circulation of medicines enter into force, the corresponding acts of the member states apply. The national rules of good clinical practice approved by Order of the Russian Ministry of Health of 1 April 2016 No. 200n «On Approval of the Rules of Good Clinical Practice» were in force through 31 August 2024. Order of the Russian Ministry of Health of 29 May 2024 No. 274n, which entered into force on 1 September 2024, repealed them.
Under the GCP Rules, the sponsor (a natural person or legal entity responsible for initiating, organizing and financing the trial) ensures that CT reports are drawn up and submitted to the authorized bodies, regardless of whether the trial was completed in accordance with the protocol or terminated early. If necessary, after the trial is completed the investigator (the medical organization) additionally submits to the institutional review board or independent ethics committee (IRB/IEC) a brief report on the outcome of the trial, and to the authorized bodies all the reports required.
The sponsor also ensures that the reports meet the requirements for the documents of the registration dossier set out in the Rules for Registration and Regulatory Review of Medicines for Medical Use, approved by Decision of the EEC Council of 3 November 2016 No. 78 (hereinafter the Registration Rules).
What changed in the requirements for the report from 10 March 2026
Decision of the EEC Council of 1 August 2025 No. 63 restated the GCP Rules in a new edition in full. It enters into force after 180 calendar days from the date of official publication. The previous edition of the GCP Rules applied from 6 May 2017 to 9 March 2026, and the new edition applies from 10 March 2026.
Decisions of the EEC that worsen the position of natural persons and legal entities have no retroactive effect (under the Statute of the Eurasian Economic Commission, which is part of the Treaty on the Eurasian Economic Union of 29 May 2014, hereinafter the EEC Statute). Decisions that improve the position may have retroactive effect if they expressly provide for it. Decision No. 63 contains neither transitional provisions nor an indication of retroactive effect. Which edition of the GCP Rules applies to a report on a trial started before 10 March 2026 is not directly determined by the acts (as of the verification date, 12 October 2026).
Table 1. Requirements of the GCP Rules for the CT report before and after EEC Council Decision No. 63
| Parameter | Previously (edition of 3 November 2016, applied through 9 March 2026) | Now (edition under Decision No. 63, applies from 10 March 2026) |
|---|---|---|
| Definition of the report | A description of a CT in written form, presented in a format that allows easy searching, drawn up in accordance with the GCP Rules and the relevant section of the requirements of the Registration Rules | A written description of a CT that combines the clinical and statistical descriptions, the presentation of data and their analysis. It is drawn up in accordance with the GCP Rules and the requirements of the Registration Rules for Module 5 when it accompanies an application for registration. The definition contains no reference to a format that allows easy searching |
| Drawing up and submitting the report | The sponsor ensures that reports are drawn up and submitted regardless of whether the trial was completed or terminated early. The report is drawn up in accordance with the applicable requirements as to form, which the GCP Rules set | The obligation is the same. The report is drawn up in accordance with the GCP Rules; the words «in accordance with the applicable requirements as to form» do not appear in the text |
| Quality management | There was no provision on quality management at all stages of the trial; the corresponding section of the GCP Rules began with the provision «Quality assurance and quality control». The report had to briefly describe the systems of quality assurance and quality control of data | The GCP Rules oblige the sponsor to ensure a quality management system at all stages of the trial, based on a risk-oriented approach. In the report the sponsor describes the approach to quality management applied, summarizes important deviations from predefined quality tolerance limits for CT parameters, and describes the measures taken |
| Storage of essential documents | The GCP Rules had no provisions on documentation of the location of essential documents or on a storage system | The sponsor and the investigator keep documentation on the location (place of storage) of essential documents, including source documentation. The storage system must ensure identification, traceability of version history, search and retrieval of documents |
| Structure of the report | Sections 1 to 16 and four groups of appendices to the report | The same sections and appendices. In the section on the trial plan, «individual institutions» is replaced by «individual medical organizations» |
What the report consists of under the GCP Rules
The report is drawn up as a single document, with tables and figures placed in the text or at the end of it. Each report contains all the sections that the GCP Rules describe for the report (they are listed in Table 2), except those that are expressly not required. The order and grouping of sections may be changed with a corresponding correction of the numbering.
Table 2. Sections of the report under the GCP Rules
| Report section | What it contains |
|---|---|
| 1. Title page | The name of the report with the product and indication, the phase of the trial, the name of the sponsor, the protocol code or number, the dates of the start and end of the trial, the person who signed the report for the sponsor, a statement on the conduct of the trial, including the archiving of essential documents, in accordance with GCP rules |
| 2. Synopsis | A brief description of the trial, usually about 3 pages. Results are presented as numerical values, except for text and p-values |
| 3. Table of contents | Page numbers of each section, the list and location of appendices, tables and case report forms (CRFs) |
| 4. List of abbreviations and definitions of terms | Abbreviations and units of measurement used in the report |
| 5. Ethical issues | Review of the protocol and amendments by the IRB/IEC, a statement that the trial was conducted in accordance with ethical principles, informed consent |
| 6. Investigators and administrative structure | Investigators and trial participants |
| 7. Introduction | Rationale for conducting the trial |
| 8. Aim and objectives of the trial | Aims and objectives |
| 9. Trial plan | Design, choice of control groups, study population, treatment, efficacy and safety parameters assessed, data quality assurance, statistical methods and sample size, changes during the trial |
| 10. Information on trial subjects | Distribution of subjects among groups, deviations from the protocol |
| 11. Efficacy evaluation | Data to be analyzed, demographic and baseline characteristics, results of the efficacy assessment |
| 12. Safety evaluation | Exposure, adverse events, deaths and other serious adverse events, laboratory values, conclusion on safety |
| 13. Discussion and overall conclusion | Discussion of the efficacy and safety results and of the benefit-risk ratio of the investigational product, without quoting the description of data and without new data |
| 14. Tables, figures and graphs that are referred to but not included in the text | Demographic data, efficacy data and safety data |
| 15. List of references | Scientific articles relating to the evaluation of results |
| 16. Appendices | Four groups: information on the trial (protocol, sample CRF, list of IRB/IEC, audit certificates, documentation on statistical methods, publications); lists of data on subjects; CRFs; list of data on each subject |
If the authorized body has permitted some appendices to be omitted, they are not submitted with the report but must be ready to be presented on its request. The applicant clearly identifies the appendices that are submitted with the report.
A shortened report based on summarized data or without some sections is permitted for uncontrolled and other trials not aimed at establishing efficacy (except controlled safety trials), for trials that are to some extent inadequate or terminated, and for trials whose aims are not related to the claimed indications. The admissibility of a shortened report depends on the policy of the authorized body of the EAEU member state in the area of regulatory review of such trials. A shortened report must contain a full description of all aspects of safety and enough information on design and results for the body to determine whether a full report is needed.
What to state in the report on changes to the plan, deviations, exclusions from the analysis and deaths
Changes in the conduct of the trial or in the planned analyses that arose after the trial began are described in the section of the report on the trial plan. It states the time and reasons for the changes, the decision-making procedures, the responsible persons, the data available and the persons to whom they were available on the date of the change. The description is mandatory regardless of whether the change was formalized by an official amendment to the protocol.
All important deviations from the protocol are described in the section of the report on trial subjects. Deviations are summarized by research center and grouped by category. Among the categories named are patients who took part in the trial despite not meeting the inclusion criteria, patients who met the criteria for discontinuation but remained in the trial, patients who received incorrect treatment or dose, and patients who received unauthorized concomitant treatment. The list of patients with deviations is given in an appendix to the report.
The section of the report on efficacy evaluation states which patients were included in each efficacy analysis. A tabular list of patients, visits and observations excluded from the efficacy analysis is placed in an appendix to the report in the form that the GCP Rules set. The reasons for exclusion are analyzed over time across all treatment groups, in the form for accounting for the number of excluded patients and observations, which the GCP Rules also set.
Deaths for each patient are listed in Section 14 of the report, including the follow-up period after completion of therapy and cases of death resulting from a process begun during the trial.
How to prepare the report as part of the registration dossier
CT reports make up Module 5 of the registration dossier. The requirements for it are set out in the Registration Rules.
Reports on controlled CTs relating to confirmation of the claimed indications for use are placed in Section 5.3.5.1 of Module 5, and reports on uncontrolled CTs, on analyses of data from several trials and on other CTs in Section 5.3.5.2. CRFs and patient lists are submitted in the same order as the reports, indexed by trial and with preservation of the confidentiality of patients’ personal data (Section 5.3.7). The dossier presents the results of all CTs, both favorable and unfavorable.
Reports are submitted, as a rule, as several documents: a synopsis, the main body of the report and appendices organized in accordance with the GCP Rules. When information changes at any stage of the life cycle of the product, documents (files) are replaced in full. The table of contents of Module 5 is detailed at least to the level of the CT report, that is, it lists each report. The sections of the report may be listed in the table of contents of Module 5 or only in the table of contents of the individual report.
The authority that carries out state registration of medicinal products provides, on request, to the authority that carries out control and supervision in healthcare (Roszdravnadzor) CT reports, including where they constitute a trade secret (under 61-FZ).
How long to keep the essential documents of the trial
Essential documents (documents that make it possible to assess the conduct of the trial and the quality of the data obtained) are kept for at least 2 years after the approval of the last application for registration of a medicinal product in a member state, and until no application is pending and no new ones are planned. The alternative period is at least 2 years after the official discontinuation of clinical development of the investigational product. A longer period applies if it is provided for by applicable requirements or by the agreement with the sponsor. In the new edition of the GCP Rules, the provision on the storage period differs from the previous one only in that the word «product» is replaced by the words «medicinal product».
The sponsor or other data owners keep all essential documents of the trial that relate to the sponsor. The sponsor informs the investigators (the medical organizations) in writing of the need to keep trial-related records and notifies them in writing when further storage is no longer needed. The CT report is included in the list of essential documents that are created after the completion or premature termination of the trial.
The new edition of the GCP Rules adds provisions on CRF data, on copies of documents and on the composition of essential documents. The sponsor makes sure that the investigator controls the CRF data transferred to the sponsor and has constant access to them. The sponsor may not establish exclusive control over these data.
Copies in place of original documents, including source documents and CRFs, must meet the requirements for certified copies. The investigator (the medical organization) controls all essential documents and records created by the investigator before, during and after the trial. The composition of essential documents is supplemented or reduced if the reduction is justified before the start of the trial.
What to do
Determine the deadline for submitting the report to the authority that issued the authorization. Count 12 months from the date of completion, suspension or termination of the trial. Send the notification of the event itself within five working days. No act containing the procedure for submitting the report has been found. Clarify the form and method of transmitting the report by a written request to the Russian Ministry of Health before submission.
Draw up a plan of the report under the GCP Rules. Include Sections 1 to 16. Decide in advance which appendices are submitted with the report and which are prepared on request, and obtain the authorized body’s permission not to submit some of the appendices. For a trial started before 10 March 2026, clarify in writing with the EEC which edition of the GCP Rules to use to prepare the report. The acts do not determine this.
Add a description of quality management to the report. Describe the approach to quality management and important deviations from predefined tolerance limits for the quality of trial parameters, together with the measures taken.
Prepare the report for Module 5 of the dossier. Place reports in Sections 5.3.5.1 and 5.3.5.2, and CRFs and patient lists in Section 5.3.7. Draw up the table of contents of Module 5 to the level of each report and submit the report as several documents: a synopsis, the main body of the report and appendices.
Set up a record of the location of essential documents and of storage periods. Keep documentation on the location of essential documents, notify the investigators in writing about storage and about its end, and note the storage period.
Regulatory framework:
1. Federal Law of 12 April 2010 No. 61-FZ «On the Circulation of Medicines» (version of 4 August 2026); the version of 19 October 2023 was used for the previous procedure for drawing up the report and for the previous deadline
2. Agreement on Uniform Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union of 23 December 2014
3. Order of the Russian Ministry of Health of 1 April 2016 No. 200n «On Approval of the Rules of Good Clinical Practice» (repealed from 1 September 2024)
4. Order of the Russian Ministry of Health of 29 May 2024 No. 274n «On Repealing Order of the Ministry of Health of the Russian Federation of 1 April 2016 No. 200n ‘On Approval of the Rules of Good Clinical Practice’» (registered by the Russian Ministry of Justice on 3 July 2024, No. 78755; entered into force on 1 September 2024)
5. Treaty on the Eurasian Economic Union of 29 May 2014 (version of 25 May 2023), together with the Statute of the Eurasian Economic Commission
6. Decision of the EEC Council of 3 November 2016 No. 79 «On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union» (as amended by Decision of the EEC Council of 1 August 2025 No. 63). The previous edition (of 3 November 2016, applied from 6 May 2017 to 9 March 2026) was used for comparison in Table 1
7. Decision of the EEC Council of 1 August 2025 No. 63 «On Amendments to the Rules of Good Clinical Practice of the Eurasian Economic Union»
8. Decision of the EEC Council of 3 November 2016 No. 78 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (version of 26 November 2025)
Commentaries:
9. Commentary to Federal Law of 12 April 2010 No. 61-FZ «On the Circulation of Medicines» (article-by-article). 2nd edition, revised and expanded. Borisov A.N. Yustitsinform, 2026