| About | Critical Path Institute (C-Path), founded in 2005 in Tucson, Arizona, is an independent, nonprofit organization dedicated to bringing together experts from regulatory agencies, industry, patient and disease foundations and academia to collaborate and improve the medical product development process.
C-Path consortia focus on specific patient populations, therapeutic areas, or cross-cutting drug development challenges. These include Alzheimer disease, multiple sclerosis, Parkinson disease, tuberculosis, neonatal therapies, and drug safety testing, among others. C-Path develops tools for evaluating the safety and effectiveness of medical products. We share ideas, we share data, and we share risks and costs to move the consensus-based science forward. |
| How we share on the Vivli Platform | The C-Path Data Collaboration Center (DCC) hosts clinical study data from multiple contributors which are anonymized, standardized and aggregated for a given disease. Metadata for the individual studies are listed for searching on the Vivli platform. To obtain the aggregated data packages hosted by C-Path for analysis in the Vivli platform, data requestors need to complete a data request through the C-Path Online Data Repository (CODR) platform. If the request is approved, the data requestor will procure the aggregated data packages directly from the C-Path CODR platform and these can be uploaded into the Vivli platform. |
| When Studies are Available for sharing | Aggregated data packages will be available for sharing once the requestor has completed the data request application through the C-Path CODR platform and has been approved for access. |
| Additional Conditions for Access | Approved users must agree to the C-Path Terms and Conditions in order to access the requested aggregated data packages. |
| What information will be provided | Anonymized, standardized, aggregated data packages will be provided to approved users. |
| Exceptions | Critical Path Institute supports responsible data sharing for legitimate research while protecting participant rights and complying with applicable legal, contractual, and governance requirements. Certain data access requests may be restricted or unavailable where sharing would be prohibited or restricted under the U.S. Department of Justice Data Security Program, including 28 CFR Part 202 and Executive Order 14117. Accordingly, C-Path reviews requests involving countries of concern or covered persons, as defined by 28 CFR Part 202, and may deny access where required to comply with applicable obligations. |
| Questions or enquiries | Questions or enquiries about C-Path aggregated data packages or the C-Path CODR platform should be made to: info@c-path.org |
| Clinical Study Register or Website | https://www.c-path.org/programs/dcc |