|About||Boehringer Ingelheim is a global, research-driven pharmaceutical company embracing many cultures and diverse societies, improving the health and quality of life of patients.|
|How we share data on the Vivli Platform||Studies available for sharing will be listed and searchable on the Vivli platform. Data requestors should use the Vivli Data Request Form to request Boehringer Ingelheim data package(s).
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.
|Studies Listed for Sharing||Studies qualify for a listing if the following criteria are fulfilled:
|Questions or Enquiries||Researchers may inquire about the availability of data from Boehringer Ingelheim clinical studies that were not listed on the site by completing an Enquiry Form.|
|When Studies are Available for Sharing||Studies are considered to be listed:
|Review Criteria for Data Requests||
|Additional Conditions for Access||
|Data Request Review Process||Access to patient-level clinical study data requires that the requestor submits a research proposal with a sound scientific rationale which is reviewed by Vivli and Boehringer Ingelheim for completeness and for compliance with the access and review criteria listed above. Furthermore, an independent external review panel reviews the proposal and considers, among other things, the scientific rationale and relevance of the research and the qualifications of the research team (see Independent Review Panel for more information)|
|What information will be provided||Where available, the following anonymized patient level data and redacted documents are provided for each clinical study:
🗹 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.
|Access to study documents without participant-level data||If you are interested in Boehringer Ingelheim clinical study documents, without patient-level data, please complete the Vivli Enquiry Form, indicating, that only documents are requested.|
|Anonymization Standards||Data Protection Procedures for Individual Patient Data|
|Clinical Study Register or Website||All Boehringer Ingelheim studies initiated after 1998 are registered on the US National Library of Medicine’s website ClinicalTrials.gov. New interventional and observational studies are registered before study start|