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OCR for page R5
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary Contents     INTRODUCTION AND BACKGROUND   1     CASE REPORTS AND PASSIVE SURVEILLANCE   2      Introduction   2      Discussion,   4      Suggested Improvements,   4      Data Analysis,   5      Signal Detection and Hypothesis Generation,   6      Use of Case Reports in Causality Assessment,   8      Education of Health Care Providers,   9      Vaccine Injury Compensation Program,   9      Evaluation of Passive Surveillance Systems,   9     LARGE-LINKED DATABASES   10      Introduction,   10      Discussion,   12      Strengths and Weaknesses of LLDBs,   12      Case Definitions,   13      Evaluation of LLDBs,   13     CLINICAL TRIALS   14      Introduction,   14      Discussion,   14      Randomization,   15      Standardization,   15      Participation in Clinical Trials,   16      Ethical Issues,   16     OTHER TOPICS   16      Unvaccinated Controls,   16      Background Incidence Rates,   17      Adverse Events with Long Latencies,   18

OCR for page R5
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary      Multifactorial Etiologies,   19      Need for Basic Research,   19     SUMMARY   20     REFERENCES   20     ACRONYMS   21     WORKSHOP PARTICIPANTS   22