受试者招募及其依从性管理 CRC的职责

2014-04-25 MedSci MedSci原创

受试者是临床试验中最主要的组成部分。试验需要什么样的受试者由方案的纳入/排除标准明确规定。受试者必须通过招募参与研究,一旦入组就必须积极参与整个临床试验。临床研究协调员(CRC )的另一个重要职责就是与受试者之间的相互交流。 受试者                      &n

受试者是临床试验中最主要的组成部分。试验需要什么样的受试者由方案的纳入/排除标准明确规定。受试者必须通过招募参与研究,一旦入组就必须积极参与整个临床试验。临床研究协调员(CRC )的另一个重要职责就是与受试者之间的相互交流。 受试者                                                 人们参加临床试验的动机是什么呢?佛吉尼亚联邦大学的一项调查显示,健康成年志愿者参加I期临床试验的主要原因是——金钱,然而不再参加后续研究的原因则是日程安排上的冲突。 除了金钱因素外,人们参加临床试验的其他原因有: 由内科医生建议作为一种治疗选择。 享受免费的医疗。 享受免费的药物。 没有其他治疗方法。 所提供的治疗方法可能改善患者的健康状况或延长寿命。 推动医学发展的奉献精神。 获得医疗教育。 无论出于什么动机,最重要的是

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    2014-08-26 yxch36
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    2014-04-27 fyxzlh
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