• Studies where there is reasonable likelihood that patients’ anonymity cannot be maintained. For example, in very rare diseases, studies with very small patient numbers or studies performed at a single center.
• When necessary to restrict information to protect commercially confidential information and intellectual property rights on occasion.
• Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical data will be excluded.
• A data request proposal competes with, and/or conflicts with our publication plan for the research.
• Studies where agreement to disclose clinical data is not gained with a co-development/research/marketing/promotion partner for a compound/product.
• Studies where clinical trial data and/or supporting documents are not in English.

The external research request must not extend beyond the limitation of participants’ informed consent.

🗹 De-identified Individual Patient Data (SDTM/ADaM dataset) This is the data collected for each patient in the clinical study.

🗹 Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical trial and information about all amendments.

🗹 Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

🗹 Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

🗹 Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Device Agency (PMDA). Documents will be redacted to protect personal data of study participants, study personnel, and Mitsubishi Tanabe Pharma employees, and to protect Mitsubishi Tanabe Pharma’s commercially confidential information and intellectual property rights. Appendices which include patient level data are not included. Mitsubishi Tanabe Pharma will not share case narratives.

• The primary manuscript of the study has been published or accepted for publication.
• The studies are for products and indications approved in the US, EU, and Japan, unless for regions where the submissions are not planned.
• Mitsubishi Tanabe Pharma must be able to provide the requested data. For example, if the request meets the exceptions, we will not provide it.
• Mitsubishi Tanabe Pharma must have the legal authority to provide the data. For example, Mitsubishi Tanabe Pharma may not have the legal authority because the medicine has been out-licensed to another company.
• Mitsubishi Tanabe Pharma must consider it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymization of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
• Whether Mitsubishi Tanabe Pharma considers that there are any practical constraints to providing access to the data. (ex. issues related to size of databases)
• There must not be any considerable operational constraints (costs, resource) to providing access to the data.
• The scientific rationale and relevance of the proposed research to medical science or patient care.
• The ability of the proposed research plan (methods and analysis) to meet the scientific objectives.
• The publication plan for the research.
• Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest.
• The qualifications and experience of the research team to conduct the proposed research.

• Data requests are initially reviewed by Vivli and Mitsubishi Tanabe Pharma for completeness and other parameters (relating to scope and meeting sponsor policies) and are then reviewed by an Independent Review Panel.
• In certain circumstances, access to data may be declined by Mitsubishi Tanabe Pharma, for example, where there is a potential conflict of interest or an actual or potential competitive risk.