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[求助]
panel screening 什么意思？
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| 求助？panel screening 什么意思？ |
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leilejiayou
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2楼2013-11-07 12:38:07
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4楼2013-11-08 15:11:31
RXMCDM
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【答案】应助回帖
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What is Panel Screening? Generally there are at least two clinic visits before you can be invited to take part in a clinical trial. Panel Screening is the first clinic appointment that volunteers are asked to attend. At this visit you will meet a member of our medical team who will answer your queries, and you will be given an Informed Consent Form (ICF) to sign. However, signing the ICF does not compel you to take part in a clinical trial – you can change your mind at any time about taking part. We will do some assessments at this visit, including taking a blood sample to check if you have had a cold, flu or other respiratory virus recently. After your panel screening visit, if your results show that you may be eligible for a trial, we will need confirmation from your GP that you don’t have any medical conditions that would prevent you from taking part in one of our clinical trials, so we will contact your GP and ask them to complete a medical questionnaire. We will also invite you to come to one of our clinics for a full health check-up. This visit is called Study-Specific Screening. During this visit you will be given an Information Sheet which will explain all of the details of the clinical trial which you are being considered for and a Consent Form to sign. If after this visit your test results show you can participate, we will discuss assigning you to a quarantine stay depending on your availability. The quarantine stay will take place in one of our healthcare and research facilities and this can be anything from 10-18 days depending on the study. Volunteers will be expected to remain in the facility for the duration of the study, but don’t worry, there’s plenty of entertainment at hand with games consoles, TVs and access to a library of video games and DVDs – not to mention three meals a day with snacks and drinks throughout. Volunteers will be carefully monitored by our medically qualified team while they are being considered for a clinical trial, throughout their stay in our healthcare and research facility, and continuing once the study is complete with follow up visits at the clinic. This is to ensure that your safety and well-being is maintained during your time with FluCamp. 筛选期检查与知情同意时间那个在先？按道理来讲应该是先知情同意再进行筛选的，然而有些病人去医院看病进行了一些检查确诊了医生觉得符合，然后再知情同意的，这种情况应该也不少见，这样符合吗？ 不可能来一个病人就签署ICF吧，不管是否参加临床试验，初步的病史询问、必要的实验室检查总是要做的吧。这些不需要等到签署了ICF才做，毕竟不是每个病人都参加临床试验的。医生通过病史询问和基本的实验室检查结果初步判断是否是目标受试者，再签署ICF，我认为是合理的。2. 对于某些实验室检查，一般临床常规是不查的，但是为了参加某项临床试验，必须进行某项筛选检查，那么这个实验室检查就必须在签署ICF以后才能进行检查。3. 有时候一个受试者在签署ICF前做的常规检查项目（例如血常规、血生化，甚至是肿瘤患者的影像） 从以上看出panel screening 为筛选期检查 |
5楼2014-01-01 22:26:16