Clinical Research Data Sharing
Chugai Pharmaceutical believes that posting information about our clinical research and sharing clinical research data by an appropriate method is vital for increasing the transparency of our clinical research and gaining the trust of society.
Sharing clinical research data with researchers also allows analysis based on the latest science and enables dissemination of findings about the applicable drugs and diseases, thus benefiting patients and improving healthcare.
In line with this stance, Chugai will post information about our clinical research and share clinical research data in accordance with The ICMJE’s data sharing statement policy(Open in a new window), while observing the laws and regulations of individual countries and industry guidelines.
Inquiries for clinical research data sharing(Open in a new window)
Posting of Clinical Research Protocols and Results
Chugai will post a summary of the clinical research protocol for patients on the clinical research registration websites.
Chugai will also post a summary of the results of the research on clinical research registration websites, irrespective of the results, if the protocol has been posted.
Sharing Clinical Research Data with Researchers
- Chugai will share with external researchers the data from clinical research conducted in patients, while observing the laws and regulations of individual countries and industry guidelines
Access to clinical research data will be shared after conclusion of an agreement or contract with the researcher on clinical research data sharing, while observing the laws and regulations of individual countries and industry guidelines, provided that the researcher qualifications, research objectives, and research protocol are all valid. This applies to clinical research data for drugs approved on or after January 1, 2014. However, data will not be shared if it is deemed that there is any risk of patients being identified. - Data from clinical research conducted as collaborative research will be shared only if the consent of the collaborating researchers is obtained.
Please click the ‘+’ below to view the pre-confirmation items and the request form.
Request for Sharing Clinical Research Data (Pre-confirmation Items for Requesting)
Pre-confirmation Items for Requesting Clinical Research Data Sharing
When completing the clinical research data sharing request form, your consent to the following terms is required. If you agree, please select "Agree and proceed to request form" to proceed.
Review, Notification of Results, and Objections
- Based on the content of your request, we will conduct an internal review to determine whether data sharing is possible. Please note that data sharing may be declined depending on the review results.
- If data sharing is not possible, we are unable to disclose the specific reasons.
- We do not accept objections to the review results or requests for disclosure regarding the review.
Agreement
- If, as a result of the review, we determine that data sharing is possible, an agreement must be concluded between Chugai and the institution (or corporation) to which the applicant belongs prior to sharing.
- The agreement will stipulate research content, research period, compliance with laws and regulations, data handling, intellectual property rights, etc., and you will be required to comply with these terms.
- The “Other Key Terms and Conditions” below are part of the terms to be observed under the above agreement. We will only accept requests if you agree to these terms prior to submitting your request.
<Other Key Terms and Conditions>
Compliance with Laws and Regulations
- In conducting the research, you must comply with all applicable laws, regulations, internal rules, ethical guidelines, etc.
Data Management, Usage Restrictions, and Obligations
- We may verify the status of data management and request corrections as necessary.
- In the event of a data breach or potential breach, you must immediately notify us and take necessary measures.
- Data may not be disclosed to anyone other than the researchers specified in the research protocol.
- Data may not be used for any purpose other than the purpose specified in the research protocol.
- Data and its analysis results may not be used for commercial purposes.
Handling of Results
- If any inventions, ideas, creations, developments, know-how, or other results are obtained through the use of the shared data, you must notify us of the details.
- Among the above results, those related to the shared data and/or Chugai products shall belong solely to Chugai.
External Publication
- When publishing the results of research using the shared data externally, you must notify us in writing in advance regarding the content, timing, and method of publication.
Publication of Clinical Research Results
Chugai will publish the results of clinical research in patients in formats such as scientific papers, irrespective of the results, while observing international standards and relevant laws and regulations.
September 2026