FIREBIRD

FIREBIRD (Federal Investigator Registry of Biomedical Information Research Data) automates the Form 1572 registration process, a key activity in the regulatory data submission process and compliance requirement for investigators participating in clinical trials. The current paper-based process results in significant cost, overhead and delays both for the investigators and the sponsors.

When implemented, FIREBIRD will function as the global investigator registry for commonly referenced data and a secure database to store, query, and structure submission information. FIREBIRD will enable investigators to register on-line with NCI and other sponsors, including pharmaceutical companies, and allow investigators to centrally maintain and manage all 1572 registrations. FIREBIRD will leverage legally enforceable digital signatures compliant with Title 21 Regulations using an Identity Assurance infrastructure, Signatures and Authentication for Everyone (SAFE).

Vision:

• Global investigator registry for commonly used/referenced data
• Automate the existing FDA Form 1572 registration process and enable investigators to register online with NCI and other sponsors, including pharmaceutical companies
• Remove paper based latencies and infrastructure costs
• Allow investigators to centrally maintain and manage all 1572 registrations
• Through a single web-based platform, investigators can maintain a secure profile of the most common information required when participating in drug trials.
• When a researcher elects to participate in a government, academic or industry drug trial, they can access and apply their profile information to regulatory submission documents such as the 1572 registration document with the click of a button.

Participants

The following Sponsors, Investigator Sites, and FDA participated in the FIREBIRD Beta v.0.5.4 The Beta was conducted in the Spring of 2005 with a follow up survey performed in Summer of 2005. Additionally, we will be conducting Alpha Testing of v.0.8.0 with members fo the FIREBIRD Core Group (NCI, FDA, & PhRMA representatives) as well as Operational Pilot of v.0.8.1 which will consist of Sponsors and Clinical Investigators.

• Sponsors
  • Cancer Therapy Evaluation Program (CTEP)
  • Division of Cancer Prevention (DCP)
  • Pfizer
  • Johnson & Johnson
• Investigator Sites
  • City of Hope
  • Johns Hopkins University
  • Memorial Sloan Kettering Cancer Center
  • Mayo Clinic
  • Moffitt Cancer Center
  • Women & Infants Hospital
• FDA (regulatory perspective)

SAFE
To ensure the success of FIREBIRD, it is imperative to establish an Identity Assurance Infrastructure, which will deliver electronic authentication and legally enforceable digital signing capabilities to all investigators, clinical research assistants, and sponsors participating in the clinical trial activities. To accomplish this, the NCI has as the pilot implemantation selected the Biopharmaceutical Industry SAFE Standard as the trust infrastructure to deliver unique credentials. SAFE (Secure Access for Everyone) will enable remote electronic authentication and digital signing of 1572 documents by clinical investigators.

View the Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute

Sample demonstration of the Firebird application.