關於 feasibility assessment ，我們在網路上蒐集到這些相關的討論、資訊與評價

➥【注意力不足過動症（ADHD）或自閉症類群的孩子，可以在課程活動中配合戴口罩嗎？】：發表在 JAMA Network Open 的一項研究指出，去年暑假在華盛頓大學自閉症中心的一項暑期治療課程中，86%的有ADHD和自閉症6-12歲的孩子，至少75%以上的時間是可以配合戴口罩的，而且這還包括午餐點心時間的空檔，原本研究人員並沒有預期孩子這段時間會戴上口罩，但他們仍然有很高的比例帶著口罩...完整轉譯文章，詳連結：http://forum.nhri.org.tw/covid19/virus/j_translate/j2645/ ( 財團法人國家衛生研究院 林煜軒醫師摘要整理)
　　
📋 JAMA - 2021-05-17
Assessment of Feasibility of Face Covering in School-Aged Children With Autism Spectrum Disorders and Attention-Deficit/Hyperactivity Disorder
■ Author：Benjamin Aaronson, Sara Nelson Glick, Christa Jefferis Kirk, et al.
■ Link：https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779931
　　
〈 國家衛生研究院-論壇 〉
➥ COVID-19學術資源-轉譯文章 - 2021/05/31
衛生福利部
疾病管制署 - 1922防疫達人
疾病管制署

【International Live Webinar Series】Strategies for Applying Clinical Trials in Europe歐洲臨床試驗申請策略與佈局

🌍此次學苑特別推出國際線上同步遠距課程，並與德國講師合作，提供學員最新的國際臨床試驗實務課程!
此次課程為系列課程，首堂為”歐洲臨床試驗申請策略與佈局”。對於想往歐洲發展、合作或與歐洲從事臨床試驗的相關公司廠商有很大的幫助!

Date:
Part 1: 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
Part 2: 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
Location：Online Webinar Training
Instructor：Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Course Outline】
Part 1 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
A. Europe – One Union with differences

B. European Clinical Trial Directive
1.Role of national competent authorities
2.Role of ethics committees (central / local)
3.Role of investigator
4.Role of sponsor
5.Role of EMA

C. Planning clinical trials in Europe
1.Analysis of product
a.Indication
b.Patient group
2.Analysis of end points
3 .Analysis of protocol
4.Preparing feasibility
5.Choosing Key Opinion Leaders
6.Sponsor or IIT?
7.Similar studies already running?

Part 2 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
A. Applying clinical trial
1.Collecting information you need
2.Establishing study team

B. Required entry into EudraCT

C. Required approval from national HAs and ethics

D. Required fulfilment of national data protection laws

E. Considerations
1.Doing it by yourselves
2.Contracting CRO
3.Auditing

F. Upcoming issues: Site and patient recruitment, site resources, patients withdrawal, protocol amendments

G. Final presentation of study reports

Online Course Fees include 2 Webinars, 90 minutes each：
Special Price $160 USD per Person; Original Price $180 USD
(*1) Certificate of Attendance will be issued only if participants attend both part 1 & 2 webinar
(*2) Certificate of Completed Assessment will be issued only if participant pass the assessment

Register here 👉 https://forms.gle/Kj9yMVynsq7yzSzs8

Organizer：ARC-TRAICOA
Co-Organizer：Salt and Light Institute

【Target Audience】
(1.) Anyone who is interested in clinical trials in Europe
(2.) Anyone who has experience in working in clinical trials related field such as PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA, etc)

【Instructor CV】
Anika Staack

Current Position:
Founder of ARC-TRAICOA
EU-Qualified Person for Pharmacovigilance (EU-QPPV)
Local German QPPV Consultant and Speaker

Previous Experience:
EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice
Senior Drug Safety Manager at ICON
Lead Site Management Associate at PRA
Clinical Research Associate at SKM Oncology

Expertise:
Expertise Databases: European Medicine Agency EudraVigilance and xEVMPD
Quality Assurance: Audits & Inspections, SOP Writing and QA documentation, recalls and product quality
Clinical Trial Management: Feasibility, monitoring, eCRF set-up, database reconciliation, site selection, contract management, patient recruitment, study reports
Authorization process: PSMF, RMP & PSUR Writing, answering authority requests, Risk Management, overseeing product life-cycle

Education Background:
Master of Science (Biology)

Email: bioschool@biotech-edu.com Tel: (+886) 02-2545-9721 ext.18

[時事英文] Goodbye, SAT and ACT!

加州大學理事會（the University of California Board of Regents）投票通過，未來5年內加州大學系統內的十所高校將逐步停用SAT 和ACT的兩項考試成績作為入學標準，自2025年將完全期銷這兩項要求!!!

想讀加州大學，也許再也不用考SAT或ACT了。

Yay?

★★★★★★★★★★★★

《洛杉磯時報》報導:

In a decision that could reshape the nation’s college admissions process, University of California regents unanimously voted to suspend SAT and ACT testing requirements through 2024 and eliminate them for California students by 2025.

1. reshape the process 重塑一項流程
2. unanimously （團體）意見一致地；（決定或裁決）一致通過地
3. suspend 停止，暫停，中止
4. eliminate 消除

加利福尼亞大學董事一致投票通過一項可能重塑美國大學錄取流程的決定，在2024年前中止SAT和ACT測驗的要求，並在2025年對加州學生取消這項要求。

★★★★★★★★★★★★

Under the plan, standardized test results will be optional on applications for the next two years and then eliminated for California students in Years 3 and 4. By fall 2025, the UC system is aiming to have its own assessment. If none is developed by then, the university will drop the SAT and ACT tests entirely for California students and evaluate them using high school grades and a dozen other factors in its comprehensive review system.

5. under the plan 根據該計劃
6. standardized test 標準化測驗
7. optional 選擇性的
8. evaluate 評估
9. comprehensive review system 綜合審核系統

根據該計劃，標準化測驗結果將在未來兩年內成為選擇性的入學申請要求，然後在第三年第四年間淘汰不為加州學生所用。到2025年秋季，UC體系的目標是擁有自己的評估系統與標準。如屆時仍未開發，則該大學將針對加州學生完全捨棄SAT和ACT測試，並使用其高中成績和綜合審核系統中其他十二項因素對學生進行評估。

★★★★★★★★★★★★

The action by the nation’s premier public university system could mark a turning point in the long-running debate over whether the standardized tests unfairly discriminate against disadvantaged students or provide a useful tool to evaluate college applicants.

10. premier 首位的，首要的
11. public university system 公立大學體系
12. a turning point 轉折點
13. a long-running debate (n.) 長期辯論
14. discriminate against 對…歧視
15. disadvantaged students 弱勢學生

美國首屈一指的公立大學體系所採取之行動可能標誌著此一長期辯論的轉折點，這場辯論是關於標準化測驗是否不公地歧視弱勢學生，或為提供評估大學申請者的有用工具。

★★★★★★★★★★★★

Throughout the years, arguments over the value of the tests have intensified. Critics say the SAT and ACT are heavily influenced by race, income and parental education levels; question the exams’ value in predicting college success; and express concern about inequitable access to test prep. Those concerns have prompted more than 1,000 colleges and universities to drop the testing requirement. A lawsuit against the UC system also calls for the requirement to be dropped.

16. throughout the years 這些年來
17. be heavily influenced by 受…大幅影響
18. parental education levels 父母教育水平
19. inequitable 不公平的
20. test prep 考試準備
21. prompt (v.) 引起；導致；激起
22. a lawsuit against 針對…的訴訟

多年來，人們對測驗價值的爭論越發激烈。批評者表示，SAT和ACT受種族、收入和父母教育水平影響深刻，也質疑考試在預測大學的成功(表現)的價值，並對不公平的考試準備之獲取表示擔憂。這些擔憂促使超過1,000所大學和學院放棄了測驗要求。一樁針對UC體系的訴訟也提出解除該要求。

★★★★★★★★★★★★

UC experts will launch a feasibility study this summer to identify a new test that assesses what the university expects students to master to demonstrate readiness for college.

23. feasibility 可行性
24. readiness 準備就緒 ; 願意，樂意

加州大學的專家將在今年夏天啟動一項可行性研究，以確定一項新的測驗，來評估大學期望學生所掌握之知識以展示準備好上大學。

★★★★★★★★★★★★

《洛杉磯時報》完整報導：https://lat.ms/2XsUAkY

圖片出處：https://n.pr/3edPwaT

★★★★★★★★★★★★

時事英文講義：https://bit.ly/2XmRYXc

時事英文大全：http://bit.ly/2WtAqop

如何使用「時事英文」：https://bit.ly/3a9rr38

★★★★★★★★★★★★

教育時評：http://bit.ly/39ABON9