英文読解問題 1 以下の課題文を読み 設問に答えてください ( 予定課題数 :5 題 10 設問程度 ) (1) Hello, Kevin. We are sorry for our delayed response. I was away from the hospital due t
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1 治験実務英語検定試験問題サンプル - Basic レベル - 試験問題は, 以下の 2 つのパートから構成されています [ パート 1] 英文読解 [ パート 2] 英文ライティング ( 適語補充問題 & 並び替え問題 & 訳文選択問題 ) 試験時間は,60 分です 試験は Web 受験で実施します そのため, 実際の受験イメージとは異なります ので, あらかじめご承知おきください なお, 実際の試験では, 各パート内でシャッフルして出題します 以下は, 試験問題のサンプルです 1 / 8
2 英文読解問題 1 以下の課題文を読み 設問に答えてください ( 予定課題数 :5 題 10 設問程度 ) (1) Hello, Kevin. We are sorry for our delayed response. I was away from the hospital due to a medical conference in Fukuoka last week. The bottles , , , , , and were all returned from the subjects unopened, and have been stored in the pharmacy storage room. They will be stored as they are until a further instruction. We are gathering information regarding the bottles which have been already opened and are going to inform you in 5 working days. Could you advise us on how we return the empty bottles? Would it be acceptable to ship them back to you with the unopened bottles? I hope this helps. Best regards, Ken 設問 1 なぜ E メールの返信が遅れたのでしょうか 1. 病気で入院していた 2. 会議に出席していた 3. 論文発表を準備していた 設問 2 被験者から回収されたボトルはどんな状態だったでしょうか 1. すべて服用済み 2. 開封済み 3. 未開封 設問 3 被験者から回収されたボトルは現在どうなっていますか 1. 製薬会社に返却済み 2. 指定の薬剤保管施設内で保管している 3. 本文中には言及されていない 設問 4 次のメールはいつ送ると言っているでしょうか 1. 5 営業日以内 2. 5 営業日目 3. 5 営業日以降 2 / 8
3 (2) SAE 報告書 ( 冒頭箇所を一部抜粋 ) Subject was a 50-year-old Caucasian male. His medical history included focal neurological deficit from 2010 to the present, loss of consciousness from 2012 to 2015, and headache whose start date is unknown. He had never participated in any clinical study before. ( ) The participant was withdrawn from the trial on November 5, 2015 because of non-small cell lung cancer, the serious adverse event. 設問 1 既往歴として述べられているのは次の内, どれか 1. 腹痛 2. 腰痛 3. 頭痛 設問 2 括弧内に入る内容として, 最も適切な選択肢はどれか 1. 被験者はすべての選択基準を満たしたため,2014 年 10 月 19 日より治験に参加した 2. 被験者は1 日 30mg 投与群に割り付けされ,2014 年 10 月 19 日に投与が開始された 3. 被験者は同意説明文書に自ら署名し,2014 年 10 月 19 日に参加の意思を示した 設問 3 被験者の治験はなぜ中止となったか, 述べられていない理由はどれか 1. 被験者が自らの意志で治験を中止した 2. 被験者の安全を考え, 医師の判断により治験薬投与を中止した 3. 被験者の体調が悪化したため, 治験薬投与が中止された 3 / 8
4 (3) GCP Subinvestigator: Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). 設問 1 治験分担医師に就けるのはどんな人と記載されているか 1. 実施医療機関に勤めている医療関係者 2. 臨床試験実施チームのメンバー 3. 治験に関係する重要な決定は下さないが, 治験業務を遂行できるメンバー 設問 2 治験分担医師と治験責任医師との関係は, どのように記載されているか 1. 治験責任医師に任命された個人 2. 治験責任医師に任命された, もしくは, 管理されている個人 3. 治験責任医師に任命され, かつ, 管理されている個人 (4) GCP The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: (a) At least five members. (b) At least one member whose primary area of interest is in a nonscientific area. (c) At least one member who is independent of the institution/trial site. Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. A list of IRB/IEC members and their qualifications should be maintained. 設問 1 治験審査委員会の委員は何名と記載されているか 1. 5 名以上 2. 5 名以内 3. 5 名未満 設問 2 委員のどのような記録が保管されなければならないか 1. 委員名簿と各委員の経験 2. 委員名簿と各委員の所属機関 3. 委員名簿と各委員の資格 4 / 8
5 (5) EDC Query Description: In the results of the laboratory hematology test performed on 1 Jun 2016, the hemoglobin is 9.8 g/dl. Is this clinically significant? If yes, the AE page should be updated. Please review and update as appropriate. 設問 1 本クエリーはどのような内容か 1. 血液学的検査の結果にあるヘモグロビン値は異常高値ではないのか 2. 血液学的検査の結果を医師は有害事象と判断しているのか 3. 血液学的検査の結果が EDC に入力されていないのはなぜか 設問 2 もし, 有害事象 (AE) を報告する場合, 具体的にどうすべきと指示されているか 1. クエリーへの返信にて AE である旨を報告し,AE に関する情報を更新する 2. ( 治験責任医師が判断した )AE の内容とその理由を確認し,AE に関する情報を更新する 3. ( 治験責任医師が判断した )AE の内容とその理由を確認し, クエリーに回答する 5 / 8
6 英文ライティング 1 次の各英文の括弧に最も相応しい表現を選択肢 1~3 より選んでください ( 予定設問数 :10 設問程度 ) 設問 1 有害事象が比較的低用量で発現した The adverse reaction ( ) with relatively low doses of this drug. 1. emerged 2. occurred 3. submerged 設問 2 血圧の上昇が見られた場合, 早急に投与を中止すること In case hypertension ( ), the study drug should be discontinued immediately. 1. will develop 2. develops 3. developed 設問 3 頭痛が 4 日前から始まった Headache started four days ( ). 1. ago 2. before 3. prior 6 / 8
7 2 課題文を読み, 最も状況にあっている記述を選択肢 1~3 より選んでください ( 予定設問数 :7~8 設問程度 ) 設問 1 The subject recovered from ulcer and [ ]. 1. was admitted to the hospital 2. started complaining of stomachache 3. was discharged from the hospital 設問 2 A marked decrease in body temperature was noted in the subject. [ ]. 1. His family withdrew the consent. 2. The investigator asked a CRC to review his medical records. 3. The used bottles of study drug were recovered from the subject. 設問 3 Query Description: In the results of the laboratory hematology test performed on 1 Jun 2016, the hemoglobin is 9.8 g/dl. Is this clinically significant? If yes, the AE page should be updated. Please review and update as appropriate. Answer: [ ]. 1. The laboratory value was not clinically significant. The AE page was updated. 2. The laboratory value was not clinically significant. I reviewed and updated it. 3. The laboratory value was not clinically significant. The physician considered this is not an adverse event. 7 / 8
8 3 課題文の意味になるよう a. から e. の語句を並べ替え, 指定の順番に来る選択肢を選んでください ( 予定設問数 :7~8 設問程度 ) 1. 主な副作用は以下の通り 発疹, 頭痛, メニエール病 [ ]: rash, headache, and Meniere's disease. (a. major / b. below / c. adverse reactions / d. shown / e. are) 5 番目に来る選択肢を選んでください 1. a. 2. b. 3. c. 4. d. 5. e 2. 予防措置の目的でスコポラミン 50mg が投与された The scopolamine was administered [ action. (a. dose / b. of / c. 50 mg / d. a / e. in) 4 番目に来る選択肢を選んでください 1. a. 2. b. 3. c. 4. d. 5. e ] for preventive 8 / 8
英文読解問題 1 以下の課題文を読み 設問に答えてください ( 予定課題数 :5 題 10 設問程度 ) (1) Hello, Kevin. We are sorry for our delayed response. I was away from the hospital due t
治験実務英語検定試験問題サンプル - Basic コース - 試験問題は, 以下の 3 つの Unit から構成されています [Unit1] 英文読解, 適語補充問題, 並び替え問題, 英文選択問題 [Unit2] 英文読解, 適語補充問題, 並び替え問題, 英文選択問題 [Unit3] 英文読解, 適語補充問題, 並び替え問題, 英文選択問題 試験時間は,60 分です 試験は Web 受験で実施します
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