Note that more information can be found in Takeda’s Anonymization and Data Protection Procedures.

• Subject identifiers: Replace by new subject number, keeping the subject-record relationship
• Site number: Replace by new site number, keeping the subject-site relationship
• Other direct subject identifiers: Suppress (e.g., kit number, device id)
• Other indirect subject identifiers (including age, race, sex, ethnicity, weight, height, BMI):
  • Retain if not identifying
  • Aggregate into bands if low frequencies
    • Note age: if age>89 then will be in the uppermost band
  • Suppress outlier or low frequency values
• Country: Retain if one country, aggregate to region if more than one country
• Adverse events, medical history, concomitant medications: Retain only the lowest level decoded dictionary term.
  • Note: if no dictionary terms then at least one variable will be retained and PII suppressed
• Comments and verbatim terms: Suppress
  • Note: comments datasets such as SDTM CO will not be provided.
• Other variables containing PII: Suppress (e.g., investigator names, lab names)
• Date of birth: Suppress – Note: age will be retained
• Study dates (full): Shift by date offset (apply a randomly chosen offset value for each subject)
• Study dates (partial): Impute to a full date, shift by the date offset, then retain year only
• Study dates (imputed): Suppress
• Study times and days: Retain

Commercially available new medicines or vaccines products that have received initial marketing approval since 01 January 2005 as follows: 

• US and EU approval. 
• US or EU approval (when regulatory submissions in both regions are not planned). 
• Japan approval (when US or EU regulatory submissions are not planned).

Clinical trials will also be listed for Takeda-sponsored Phase 1-4 interventional trials relating to terminated compounds. Terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 January 2014. 

• Takeda will only share clinical data when it is feasible to anonymize the data without compromising the privacy of study participants. This may affect small clinical studies of rare diseases or studies conducted in a very small, easily identifiable subject population, which will be reviewed on a case-by-case basis. Prematurely discontinued studies that have insufficient enrollment/exposure to warrant analysis may not be listed.
• Data will generally only be shared once a study has completed and sufficient time has elapsed to complete analyses/reporting and pursue a publication from the final data analysis (subject level data from interventional phase 2 and 3 studies that are part of an approved Takeda compound will be shared as described in the next section). Interim data from clinical studies will generally not be shared by default, although efforts will be made to share such data in long-term, event-driven studies (such as oncology).
• In rare cases, information may be restricted/proposals not progressed by Takeda in order to protect commercially confidential information (CCI) and intellectual property (IP) rights.
• Requests will not be approved if there is an actual or potential conflict of interest related to the Data or Requestor including, but not limited to, requests for competitive, commercial or legal purposes.
• Takeda Consumer Healthcare products will not be subject to data sharing.

• Clinical studies will generally be eligible for listing once the above criteria are met, time has elapsed to allow analysis of the data and reporting to occur, and the primary manuscript has been submitted for publication. For phase 2 and 3 interventional studies that are part of an approved Takeda compound, Takeda will share subject level data within 18 months following completion of the study or 6 months following EU/US approval or Japanese approval (when EU or US approval was not sought), whichever is the later date.
• Clinical studies supporting subsequent local approvals (including registration studies that specifically support approval in Japan), new indications, combination products, or major formulation changes for products that received initial approval since 01 January 2005 will be eligible for listing after the corresponding regulatory approvals have been achieved.
• Takeda will regularly update this list to add studies meeting the criteria. For in-scope studies that are not yet listed, Takeda will assess the feasibility of data provision as part of the review of enquiries.

• The Research Proposal is compatible with study informed consent.
• The data and studies are available to perform the analysis.
• The planned analysis can be conducted in the data access system.
• The scientific rationale and relevance of the proposed research to medical science or subject care.
• The ability of the proposed research plan (design, methods, and analysis) to meet the scientific objectives. This is a high-level review.
• 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. Such conflicts may relate to (but are not limited to) the research team, their institutions/affiliations, or their relationships to independent review panel members and Vivli staff.
• The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team).

• Data sharing is constrained by the requirements of the informed consent obtained at the time each clinical trial was conducted and applicable legal requirements. In general, new research conducted on shared data must assess the specific medicine, disease or objective that was assessed in the original trial. For Takeda clinical trials initiated after this policy is enacted, patients will be asked to give permission for broader research beyond the original trial, so that other research may be possible with these data. 
• Where data is subject to legal, contractual, or consent provisions that restrict transfer to third parties, data access may be precluded. 
• Other practical constraints to providing access to the data may also preclude sharing. 

🗹  Individual Patient Data. This is the data collected for each patient in the clinical trial.

🗹 Analysis-ready dataset. This is the dataset used for Takeda’s analysis.

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

🗹  Annotated Case Report Forms (CRFs). This is a blank case report form with descriptions of the data collected and how they are described in the dataset. This will be provided when available.

🗹 Reporting and analysis plan. This describes statistical analysis plans that include methods of analysis, procedures for data handling, and data displays (figures and tables) that Takeda used for the trial.

🗹 Dataset specifications. This is the metadata 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 trial. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices that include patient-level data are generally not included as these data are found in the datasets Takeda provides.

Documents will be redacted to protect personal data of trial participants, trial personnel, and Takeda employees (consistent with applicable privacy laws/regulations), and to protect Takeda’s CCI and IP rights when required. Takeda will generally not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, MRI scans), genetic data, or other information that Takeda considers may compromise trial participant privacy.