A quantitative risk assessment using the k-anonymity algorithm is conducted on simulations of rules applied to identifiers to anonymize data in a way that protects patient privacy whilst retaining the highest levels of data utility.

• Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: Removal of identifiers such as kit numbers and devices.
• Site ID: Removed.
• Date of birth: Removed. Replaced with age at screening.
• Age: banded.
• Country: retained where possible or lower frequency (LF) countries will be grouped together and recoded to LF.
• Ethnicity: retained where possible or lower frequency ethnicities will be grouped together and recoded to LF.
• Race: retained where possible or lower frequency races will be grouped together and recoded to LF.
• Sex: retained where possible
• Height: banded where possible, but often redacted to protect patient privacy
• Weight: banded where possible, but often redacted to protect patient privacy
• BMI: banded where possible, but often redacted to protect patient privacy
• Dates/Times related to study subject: Date shift by random shift factor. Same factor for all dates of a patient, however different factor per patient. Time remains unchanged.
• Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events and medical history: Verbatim term replaced by coded dictionary terms.
• Rare/Sensitive or Identifying adverse events/Medical history: Redacted.

Anonymization Standards

• United States (US) and the European Union (EU)
• US or EU (when regulatory submissions in both regions are not planned)
• Japan (when US and EU regulatory submissions are not planned)
• US and Japan
• EU and Japan

• Studies with a primary or interim analysis that have not reached a global end or completion
• Non interventional and Phase I studies in healthy volunteers
• Studies where there is reasonable likelihood that patients’ anonymity cannot be maintained. For example, in very rare diseases, studies with very low patient numbers or studies performed at a single center.
• When necessary to restrict information to protect commercially confidential information and intellectual property rights on rare occasions.
• Data collected subject to legal, contractual, consent provisions or ongoing regulatory review that prevent further sharing of clinical data will be excluded.
• A data request proposal competes with, and/or is in conflict with our publication plan for the research.
• Studies where the data or documents are not in English.

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

🗹 Individual Patient Data (raw/SDTM). This is the data collected for each patient and used for analysis in the clinical study.

🗹 Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization 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 synopsis. 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 Daiichi Sankyo employees, and to protect Daiichi Sankyo’s commercially confidential information and intellectual property rights. Appendices which include patient level data are not included. Daiichi Sankyo will not share case narratives.

• The study has reached a global end or completion with all data set collected and analyzed.
• The primary manuscript of the study has been published or accepted for publication.
• Daiichi Sankyo must be able to provide the requested data. For example, some non-interventional (or observational) studies use data from third party databases under license agreements which prevent Daiichi Sankyo from providing access to the data. Researchers may seek access to data directly from these third-party databases under similar agreements.
• Daiichi Sankyo must have the legal authority to provide the data. For example, Daiichi Sankyo may not have the legal authority because the medicine has been out-licensed to another company.
• Daiichi Sankyo 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.
• There must not be any considerable operational constraints (costs, resource) to providing access to the data.

• Access to data is determined by the Independent Review Panel based on the scientific merit of the research proposal.
• In exceptional circumstances, access to data may be declined by Daiichi Sankyo, for example, where there is a potential conflict of interest or an actual or potential competitive risk or where legal, contractual, consent provisions or ongoing regulatory review prevents Daiichi Sankyo from sharing clinical data.

Additionally, published Clinical Document Packages per Health Canada’s Public Release of Clinical Information and European Medicines Agency’s Policy 0070 on the respective agency-controlled websites and databases may be accessed.