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About Endo is a diversified specialty pharmaceutical company. Learn more at www.endo.com. Endo is making available (as described below) data and information for Endo-sponsored studies relating to Opana® (oxymorphone hydrochloride) and Opana® ER (oxymorphone hydrochloride), i.e., pre-marketing clinical research and post-market clinical research for which Endo is a sponsor (as defined in 21 C.F.R. §312.3(b)) and that involve an intervention with human subjects (“Opana® Studies”).
How we share on the Vivli Platform Endo’s Opana® Studies are listed on Vivli. Data requesters should use the Vivli Data Request Form to request data package(s). If the request is approved by Vivli, Endo will upload anonymized data and supporting documents into the Vivli platform for use by researchers in Vivli’s secure research environment.
Anonymization Standards   Prior to uploading data and information, it will be anonymized in accordance with applicable laws and regulations.
Studies Listed for Sharing Opana® Studies
Exceptions None
Questions or enquiries Please contact support@vivli.org
When Studies are Listed After the data request is approved by Vivli and the data is anonymized. The timeline for anonymization will depend on the number of studies and amount of data being shared.
Review Criteria for Data Requests Access to data will be granted to any qualified researcher with a complete bona fide scientific research proposal.
Additional Conditions for Access A Data Use Agreement (DUA) with the research team must be executed prior to the researcher(s) being able to access data within the Vivli platform.
Data Request Review Process Proposals that have been received via Vivli will be reviewed for scientific merit by the Independent Review Panel members according to their charter.
What information will be provided Available anonymized, patient-level and study-level clinical trial data and other information (including protocols, clinical study reports, and statistical analysis plans) will be provided.
Access to study documents without participant-level data Access to Clinical Protocol and Clinical Study Reports may be provided without participant level data, upon approval of the research proposal and execution of the Data Use Agreement.
Clinical Study Register or Website https://www.endo.com/