Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10966574 | Vaccine | 2013 | 7 Pages |
Abstract
⺠Standard safety data collection methods for pIMDs in clinical trials are proposed. ⺠pIMD lists and disease-specific standard questionnaires will enhance data collection. ⺠The theoretical risk period is at least 6 months, up to 1 year after the last dose. ⺠Baseline biomarker measurement could eventually provide valuable information. ⺠Standard case definitions are useful tools for establishing diagnostic certainty.
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Authors
Fernanda Tavares Da Silva, Filip De Keyser, Paul-Henri Lambert, William H. Robinson, René Westhovens, Christian Sindic,