[KIC > 신규]
임상시험종사자 직능(식약처 기준)
시험책임자(PI) / 시험자(SubI) / 관리약사 / IRB위원(의사) / IRB위원(의사 외) / 코디네이터(CRC) / 품질보증담당자(QA) / 모니터요원(CRA)신규자 /
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Traditional randomised controlled trials (RCTs) generate evidence of efficacy but cannot alone inform the true value of a medicine in actual clinical practice. It is this value that is increasingly being required by regulators, payers, providers, and formularies; and the need for this evidence is driving significant investment in electronic medical records and associated infrastructure by governments, healthcare providers and industry.
There are also challenges to overcome before RWE generation and acceptance becomes more systematic, including geographic coverage, incompleteness of data, data quality, linking different data sources, and concerns around consent management and ethics of data use.
There are also challenges to overcome before RWE generation and acceptance becomes more systematic, including geographic coverage, incompleteness of data, data quality, linking different data sources, and concerns around consent management and ethics of data use.?
평가기준 | 집합 출석율 | 온라인 진도율 | 시험 | 과제 | 토론 | 기타 |
---|---|---|---|---|---|---|
배점비율 | - | 90.00% | 10.00% | - | - | - |
과락기준 | - | 80% | 60점 | - | - | - |