Regulatory Project Database

What is the Regulatory Project Database?

The Regulatory Project Database is a web-based database available for download that is designed for tracking and facilitating FDA regulatory support at an academic medical center/institution.  The database was developed in REDCap by the Duke Office of Regulatory Affairs and Quality (ORAQ) and the Duke Office of Clinical Research (DOCR) with support from the Clinical and Translational Science Awards (CTSA).

Key functions of the Regulatory Project Database:

  • Intake Survey: Public survey URL allows faculty and study teams to submit a regulatory service request to a central regulatory office/team.
     
  • Annual Reporting Reminders: Automated reminder e-mails for annual or progress reports for 7 regulatory application types to help ensure reporting compliance (at 60 days, 30 days, 14 days, 7 days, and 0 days before the due date).
     
  • Institutional Regulatory Support Tracking: Central tracking of key information on all regulatory applications, regulatory submissions, regulatory meetings, and/or regulatory correspondence across your university or institute.
    • Captures and tracks information on 16 submission and application types
    • Ability to upload/store central copies of all regulatory submissions and correspondence
       
  • Automated Submission Workflows: Ability to assign Action Items as an efficient mechanism to communicate with others involved in the submission process or to track task completion.  Facilitates automated e-mail to Sponsor and study team containing a merged copy of the regulatory submission.
     
  • Project Tracking: Ability to track consultations and projects supported by a central regulatory office, including the level of involvement and type of support.  Ability for staff members to view their specific project information on customized dashboards.
     
  • Reporting: Ability to generate customized reports to easily obtain metrics on your office’s project workload, number and type of applications supported, number of regulatory submissions, etc.
     
  • Manufacturing Information: Captures manufacturing information on 5 product types, including the location of manufacturing, stability testing, and/or release testing. Ability to track the party responsible for releasing the product(s) and allows for the upload of any associated Quality Agreements.

What regulatory application and submission types can be tracked in the database?

The database contains customized fields for the following application and submission types: 

  • Investigational New Drug (IND), including expanded access
  • Investigational Device Exemption (IDE)
  • Investigational Tobacco Product (ITP)
  • Drug Master File (DMF)
  • Device Master Access File (MAF)
  • Health Canada Clinical Trial Application (CTA)
  • Biologics License Application (BLA)
  • Orphan Drug Designation (ODD)
  • Emergency Use Authorization (EUA)
  • Device Emergency Use or Compassionate Use Request
  • Meeting (non-Q-sub)
  • Q-Submission
  • Request for Designation (RFD) or Pre-RFD
  • Freedom of Information Request (FOIA)
  • Export Request
  • Establishment Registration
  • Product Listing 

How do I request access to the database for my institution?

To request access to the Regulatory Project Database for use at your institution, please complete our online form. After we receive your request, we will contact you via e-mail with a link to download the Regulatory Project Database. There is no cost associated with downloading the database.

What is required to set up the database at my institution?

Knowledge of the REDCap system or technical support with REDCap is required.  Key information on how to implement the database at your institution will be provided with the database download.   There are certain REDCap external modules that are currently enabled in the project.  As you customize the database to fit the needs of your institution, please note that you can choose to implement only some functions or forms within the database if certain features are not applicable to your group.  

What are the key benefits of using the Regulatory Project Database at my institution?

Some of the benefits noted by our Duke team since implementing this database in 2022:

  • Easier to identify relevant example submissions across the office for reference
  • Easier to cover for a colleague during leave or staff turnover
  • Easier reference to project history and past FDA commitments for a project
  • Improved efficiency with automated workflows and reminder notifications
  • Improved metrics reporting capabilities system

Are there resources for navigation and use of the Regulatory Project Database?

Please email the ORAQ shared inbox at ORAQ@dm.duke.edu for general questions related to the Regulatory Project Database. A database information sheet will also be provided upon receipt of the database download request, but please be aware that we are unable to provide ongoing technical support with implementing or customizing the database at your institution.

Request Regulatory Project Database