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1. Why is Oracle involved in these efforts?
COVID-19 has had a devastating impact on people and businesses around the world. Oracle is committed to using its technology, resources and data expertise to speed treatment and vaccine efforts.
2. What is the COVID Prevention Trials Network (CoVPN)?
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has created a new clinical trials network that will be responsible for enrolling thousands of volunteers to participate in large-scale clinical testing of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.
3. What is the intended benefit of the network?
An effective biomedical tool to prevent coronavirus disease is of paramount importance. By centralizing efforts into a single clinical trial network, the United States will be able to expand the resources and expertise needed to focus on finding and developing a safe and effective vaccine or monoclonal antibody for COVID-19.
4. What is Oracle’s role in CoVPN?
Extending its collaboration with the HHS and NIH in the fight against COVID-19, Oracle has built and donated a customized data collection platform to support the creation of a screening registry to identify potential trial participants. The network is expected to operate close to a hundred clinical trial sites across the United States to start.
5. How do potential candidates access the Oracle system?
People interested in learning more about the different stages of vaccine research and potentially participating in the network’s COVID-19 vaccine or monoclonal antibody studies can learn more on the CoVPN website. Once on the website, interested parties will be directed to the Oracle data platform to provide demographic information. The information collected will be shared with participating clinical trial sites.
6. Does Oracle own the data, how else will they be using it?
Oracle built and donated the data collection and analysis platform for the United States government. Oracle does not own the data and the NIH will be using the platform to collect participant information to share with CoVPN and eligible clinical trial sites.
7. Does Oracle decide who is eligible for the trials?
No. Oracle does not own the data and the NIH will be using the platform to collect participant information and share it with the CoVPN and eligible clinical trial sites. Clinical study staff will use the registry to contact and screen potential study volunteers.
8. How much does it cost to use the system?
The system was developed for free. There is no cost for potential study participants to enter their information.
9. Who can see the data entered into the system?
Authorized CoVPN members and trial site staff can see the individual and aggregated data entered for all participants who voluntarily provided information. Clinical study staff will use the registry to contact and screen potential study volunteers.
10. Is the system secure and HIPAA compliant?
Yes, the system features enhanced-security protections to allow interested individuals to sign up for a rolling clinical trial participant registry. According to HHS, entry of volunteer information into this system is fully compliant with HIPAA. Learn more at https://www.hhs.gov/hipaa.
11. What Oracle technologies are involved?
The platform is built on Oracle Cloud Infrastructure, APEX and Oracle Database Exadata Cloud Service. Experts from the Oracle Health Sciences team were also critical in building the platform and advising the HHS and NIH in these endeavors.