This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.  We, FDA, recommend submission of these datasets as part of the applicant’s data tabulation datasets.  The submission of standardized datasets facilitates review and analyses of the data and allows for pooling of data, when appropriate.  These specifications reflect current CBER OVRR thinking, are built to be consistent with the FDA Study Data Technical Conformance Guide , and are generally consistent with the Therapeutic Area User Guide (TAUG) for Vaccines.

 

Posted on the FDA website on 20 December 2019