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Certificate of Confidentiality

Problem

Certificates of confidentiality are an important tool used by researchers to protect the privacy of study participants. At the National Institutes of Health (NIH), the Nation's Medical Research Agency, each institute individually manages a process for issuing certificates to eligible applicants. The entire process, from application to review and issuance is paper-based. Tracking progress and managing multiple applications is time-consuming for the Institute and it frequently takes weeks before the final certificate is issued. When certificates are delayed, researchers are often unable to begin study recruitment and the science is impacted.

Resolution

Woodbourne Solutions built a custom web application that standardizes the certificate application and automates the entire process for researchers and NIH certificate coordinators. The Clinical Certificate of Confidentiality System (CCC) provides an easy-to-use application form that researchers can access from an Institute’s public web site. The CCC ensures that researchers submit the required information and provides instant confirmation when an application is successfully submitted. The CCC also has a staff-side component where coordinators are able to track application receipt and manage internal review. Once an application is approved, the CCC will produce a final certificate on demand by combining predefined application content, the standard NIH boilerplate language and Institute specific information.

Value Added

The CCC was built in 2008 for the National Institute of Child Health and Human Development (NICHD). Certificate coordinators at NICHD reported their average processing time was reduced from 10 weeks to 10 days. The CCC is now being used by nine of NIH’s 27 institutes who are also benefiting from reduced processing time and enabling their applicant researchers to start study recruitment sooner than before.

Technologies Used

Woodbourne Solutions built the Certificate of Confidentiality Application with .Net, an Oracle database and Active PDF. User access is controlled via Active Directory groups and leverages the NIH login.

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