• Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: Removal or recoding of identifiers such as kit numbers and devices.
• Site ID: Recoded
• Date of birth: Provide age at randomisation.
• Age: Aggregation of Age >89.
• Country: Retained
• 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. So, the durations remain same and unique to every patient. Time remains unchanged.
• Comments, freetext, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events and medical history: Verbatim terms are removed; dictionary coded terms are retained.
• Verbatim term of concomitant medications: Removed; dictionary coded terms are retained.

• Phase 2, 3 or 4 studies used as part of a regulatory approval submitted to the US Food and Drug Administration (US FDA) on or after 1999.
• Phase 2, 3, or 4 global studies in indications approved in both the US and EU with a first patient visit after 1 January 2007.
• Phase 2, 3, or 4 regional/local studies in indications approved in both the US and EU with a first patient visit after 1 January 2014.

Additional studies outside of this scope may be proactively listed by Lilly.

Interventional clinical studies where Lilly is the sponsor but does not have the legal authority because the medicine has been out-licensed to another company or the data are the property of an academic organization.

Datasets for which the total number of U.S persons exceeds the bulk thresholds set by the DOJ regulations at 28 CFR § 202.205 and the requestor is a country of concern or covered person as defined by 28 CFR § 202.209 and § 202.211.

Data will not be provided to requestors where there is a potential conflict of interest, data is to be used for a commercial purpose or there is an actual or potential competitive risk.

Data will not be provided to requestors to construct an AI-ML model that will serve as the foundation for a commercial product.

• Raw dataset. This is the data collected for each patient in the clinical study. PK data is not routinely provided.
• Analysis-ready dataset. This is the dataset used for Lilly’s analysis. PK data is not routinely provided.
• Protocols with any amendments or addenda. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.
• Annotated case report form. This is a blank case report form with descriptions of the data collected, metadata and how they are described in the dataset. If an annotated case report form is unavailable, a blank case report form may be provided.
• Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Lilly used for the study.
• Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, 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 US FDA and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the datasets Lilly provides. To protect research participants’ privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants’ privacy can be protected.
• Anonymization Guidance. This includes a guide to anonymized datasets, describing general anonymization methods.

Documents will be redacted to protect personal data of trial participants, trial personnel, and Lilly employees (consistent with applicable privacy laws/regulations), and to protect Lilly’s CCI and IP rights when required. Lilly will generally not share case narratives, documentation for event adjudication, images (e.g., x-rays, MRI scans), genetic/genomic, or other “omic” data, or other information that Lilly considers may compromise trial participant privacy. Supporting documents will not be translated and in rare instances, practical issues relating to redaction and availability of non-English documents may limit sharing.

• 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 patient 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.

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).

• The scientific rationale and relevance of the proposed research to medical science or patient 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.
• 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)