All about DIBD

 

What DIBD Means

DIBD = Development International Birth Date
This is a regulatory term defined as:

“The date of first approval (or authorization) for conducting an interventional clinical trial in any country, or the date the IND application went into effect.”

It is used as the starting point for cumulative safety reporting in documents such as DSURs, PBRERs, and other developmental safety reports.

You can see DIBD referenced across your project files, for example:

  • Safety tables and listings repeatedly specify analysis periods such as “Analysis Period: DIBD – XXNOV2023.”

How DIBD Is Used

DIBD defines the beginning of the cumulative reporting window for:

  • DSUR (Development Safety Update Report)
  • PBRER (Periodic Benefit-Risk Evaluation Report)
  • Safety listings and tables across studies

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