"Technical Specifications Document"
"1.0 Introduction
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...
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities... The use of the word should in FDA’s guidance means that something is suggested or recommended but not required...
3.0 Submission of Safety Data for Vaccine Trials
Safety data submitted for vaccine clinical trials should include reactogenicity data (i.e., a set of prespecified AEs [adverse events] collected within a prespecified time frame, often referred to as solicited AEs or reactions), unsolicited AEs, medically attended adverse events (MAAEs), and death. The sections below will detail the usage of domains and variables expected in submissions to OVRR. Any usage of domains and variables that differ from these recommendations will need to be agreed upon prior to submission of datasets...
7.0 Submission of Data for Maternal Immunization Trials
... Since the amount of vaccine that reaches the fetus is unknown, the Dose Description (DOSTXT) variable in EX [Exposure] is utilized, and 'Fetal Exposure' should be noted instead of populating the variable Dose (DOSE). The reproductive findings (RP) domain should be used to report the maternal date of last menstrual period, and from this, the gestational age at exposure can be calculated and reported in RP."
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