Abbreviated Full Data Set Sample Clauses

Abbreviated Full Data Set. For phase 1 and “Experimental Medicine” phase 1 studies, CAVD Members may provide a subset of the full data set. Experimental medicine studies are defined as those that are not intended to establish a substantial safety data base, or where the substances being tested are not intended to be developed into a drug or vaccine, or where the studies only enroll a very small number of participants to assess an important biomedical concept. For these phase 1 and experimental medicine phase 1 studies, an abbreviated version of the “full data set” containing study and product descriptors, demographic and baseline characteristics of participants and the key immunogenicity or assay data are acceptable. The following elements are those included in an “abbreviated full data set”:
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