If the request is approved, researchers will need to sign a Data Use Agreement. The anonymized data and redacted documents will be provided in a secure research environment on Vivli to further protect participant privacy.

• 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: Aggregation of Age >89.
• Country: Aggregation to region level in case of countries with only one site.
• 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, freetext, 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.
• Verbatim term of concomitant medications: Removed. No replacement by coded dictionary terms due to license restrictions. 

More information can be found in the Data Protection Procedures for Individual Patient Data and in the Boehringer Ingelheim Clinical Trial Data Transparency Guide to Anonymized Datasets which will be provided together with the anonymized Data Package. 

• Phase I to IV interventional as well as non-interventional studies
• Studies initiated after 1 January 1998
• Studies for which Boehringer Ingelheim received drug approval or where the drug development program was terminated
• Studies, where data is available in Boehringer Ingelheim’s Clinical Trial Data Database (For example, the majority of non-interventional (or observational) studies use data from third party databases under license agreements which prevent Boehringer Ingelheim from providing access to the data. Researchers can request access data directly from these third party databases).
• Boehringer Ingelheim has the legal authority to provide the data for a particular study. In some cases, contractual obligations vis-à-vis third parties or other restrictions may not allow sharing documents or data (e.g. medicine has been out-licensed).
• Responsible data sharing must respect the boundaries of the informed consent of study participants and data protection regulation. In rare cases, the limitations of the informed consent of study participants might not allow data sharing.

• Clinical studies of rare diseases or single center studies. Anonymization of these data is often not feasible without compromising the privacy and confidentiality of research participants. For these studies Boehringer Ingelheim will assess the feasibility of anonymization as part of the review of enquiries, and/or will try to address requests by providing summary data or otherwise.
• Pharmaceutical formulation studies and associated analytical methods, as well as studies pertinent to pharmacokinetics using human biomaterials. Boehringer Ingelheim believes that the reports and data for such studies primarily contain commercially confidential information (CCI) and intellectual property (IP).
• Case narratives, image data (e.g. x-rays, MRI scans), genetic/genomic data or other information that Boehringer Ingelheim considers may compromise trial participant privacy.
• Studies, where Boehringer Ingelheim is collaborating with academic centers for the analysis and publication of study results. In these cases, inquiries might be referred to these centers.
• Where compliance with data protection guidelines cannot be ascertained.

• One year after primary endpoint completion date AND
• After structured results have been posted on Clinicaltrials.gov AND
• After regulatory review has been completed (this typically refers to the completion of the regulatory reviews and approvals in EU and US, but might for example also apply to the completion of the review and approval by other regulatory authorities for a dedicated national study, etc.) or after termination of the development program AND
• After the primary manuscript describing the results has been accepted for publication.

• The 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 qualifications and experience of the research team to conduct the proposed research.
• If a research proposal competes with the Boehringer Ingelheim publication plan, Boehringer Ingelheim will decline the research proposal and inform the researcher accordingly. The research proposal can be re-submitted at time of publication, if the researcher desires.
• The data requested in the research proposal are available

• The researcher seeks publication of the research results in a peer-reviewed journal providing Boehringer Ingelheim with a copy of any proposed manuscript prior to submission.

🗹 Raw dataset. This is the data collected for each patient in the clinical study.

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

🗹 Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study. The protocol is part of the appendices of the clinical study report.

🗹 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.

🗹 Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Boehringer Ingelheim used for the study.

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

🗹 Clinical study report without appendices. 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) and the European Medicines Agency (EMA).

Documents will be redacted to protect personal data of study participants, study personnel, and Boehringer Ingelheim employees, and to protect Boehringer Ingelheim’s commercially confidential information, including intellectual property rights.