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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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【答案】應(yīng)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. 篩選期檢查與知情同意時(shí)間那個(gè)在先？按道理來講應(yīng)該是先知情同意再進(jìn)行篩選的，然而有些病人去醫(yī)院看病進(jìn)行了一些檢查確診了醫(yī)生覺得符合，然后再知情同意的，這種情況應(yīng)該也不少見，這樣符合嗎？ 不可能來一個(gè)病人就簽署ICF吧，不管是否參加臨床試驗(yàn)，初步的病史詢問、必要的實(shí)驗(yàn)室檢查總是要做的吧。這些不需要等到簽署了ICF才做，畢竟不是每個(gè)病人都參加臨床試驗(yàn)的。醫(yī)生通過病史詢問和基本的實(shí)驗(yàn)室檢查結(jié)果初步判斷是否是目標(biāo)受試者，再簽署ICF，我認(rèn)為是合理的。2. 對(duì)于某些實(shí)驗(yàn)室檢查，一般臨床常規(guī)是不查的，但是為了參加某項(xiàng)臨床試驗(yàn)，必須進(jìn)行某項(xiàng)篩選檢查，那么這個(gè)實(shí)驗(yàn)室檢查就必須在簽署ICF以后才能進(jìn)行檢查。3. 有時(shí)候一個(gè)受試者在簽署ICF前做的常規(guī)檢查項(xiàng)目（例如血常規(guī)、血生化，甚至是腫瘤患者的影像） 從以上看出panel screening 為篩選期檢查 |
5樓2014-01-01 22:26:16
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