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<Upper-Intermediate> Lesson No.15

International Clinical Trial Network Development Discussion / 国際治験ネットワーク構築協議

0.Greetings & Ice-break (2min.)|挨拶と導入

 

0-1 Greetings

Let’s practice a short small talk that you can use to greet a business partner and start building a good relationship.

講師との挨拶を兼ねて、ビジネスパートナーと信頼関係を築くための短いスモールトークを練習してみましょう。

[Tips / 会話のヒント]

・Can you hear me clearly? 

 私の声はクリアに聞こえますか?
・How's your day going so far?

 今日はどんな一日でしたか?
・Talk about one small topic (Work, Weather, News, Hometown, Sports event, etc.)

 軽い話題について話しましょう(仕事、天気、ニュース、地元、スポーツイベントなど)

0-2 Introduction​

In today’s lesson, we’ll learn about the following situation. Have you ever experienced something similar?

本日のレッスンでは以下のようなシチュエーションについて学びます。同様のシチュエーションを経験したことがありますか?​

​​

- If you have experience, please tell us what it was like, what was difficult, or what you learned.

   経験があれば、どんな内容だったか、難しかったことや学んだことなどを教えて下さい。 

- If you don’t have experience, try to imagine yourself handling that situation in English.

  What do you think would be challenging?

  経験がなければ、英語でその状況に対応しているところを想像してみましょう。どんなことが難しそうですか?

Situation / シチュエーション

This involves discussing the construction of global networks with medical institutions worldwide for efficient implementation of international clinical trials.
世界各地の医療機関とのネットワーク構築を協議し、効率的なグローバル臨床試験実施体制を構築する場面です。

1. Read (2 min)|型を学ぶ
Let's read the following key sentences aloud!
下記の文章や単語を順番に音読しましょう!

1-1 Basic phrases
1.I recommend three regions...(3つの地域をお勧めします...)
2.We evaluate three factors systematically...(3つの要素を体系的に評価します...)
3.We assess their previous trial completion rates...(過去の治験完了率を評価します...)
4.We will establish regional hubs in...(...に地域ハブを設立します)
5.Each hub will coordinate local sites...(各ハブは現地施設を調整します...)
6.This structure reduces delays and ensures...(この構造は遅延を削減し...を確保します)
7.We estimate 6 months for...(...には6か月と見積もっています)

1-2 Essential words
1.accelerate(加速する)
2.moderate(適度な)
3.assess(評価する)
4.monitor(モニターする)
5.overcome(克服する)
6.coordinate(調整する)
7.utilize(活用する)
8.launch(立ち上げる)
9.submit(提出する)
10.validation(検証)
2. Try  (3 min)|ロールプレイ練習

Let’s practice the role-play.

ロールプレイの練習をしましょう!

Situation / シチュエーション(Reference again)

This involves discussing the construction of global networks with medical institutions worldwide for efficient implementation of international clinical trials.
世界各地の医療機関とのネットワーク構築を協議し、効率的なグローバル臨床試験実施体制を構築する場面です。

👨‍💼【Teacher / Clinical Operations Director】:
Thank you for meeting today. We need to accelerate our global trial network. Which regions do you recommend we prioritize for patient recruitment?
(本日はお時間をいただきありがとうございます。グローバル治験ネットワークを加速する必要があります。患者リクルートメントにおいて、どの地域を優先すべきとお考えですか?)
🧑‍🎓【Student / Clinical Research Manager】:
I recommend three regions. First, Eastern Europe offers strong recruitment capability at moderate cost. Second, Southeast Asia has large patient populations with diverse genetics. Third, North America ensures regulatory consistency with our headquarters.
(3つの地域をお勧めします。第一に、東欧は適度なコストで強力なリクルート能力を提供します。第二に、東南アジアは多様な遺伝的背景を持つ大規模な患者集団を有しています。第三に、北米は本社との規制上の一貫性を確保します。)

👨‍💼【Teacher / Clinical Operations Director】:
That sounds reasonable. However, I am concerned about quality control across multiple sites. How do you assess each facility's research capability?
(それは妥当に聞こえます。しかし、複数の施設にわたる品質管理が心配です。各施設の研究能力をどのように評価しますか?)
🧑‍🎓【Student / Clinical Research Manager】:
We evaluate three factors systematically. We assess their previous trial completion rates, inspect their equipment and staff qualifications, and monitor their patient retention records. Sites with completion rates above 90 percent are prioritized.
(3つの要素を体系的に評価します。過去の治験完了率を評価し、設備とスタッフの資格を検査し、患者維持記録をモニターします。完了率が90パーセント以上の施設を優先します。)

👨‍💼【Teacher / Clinical Operations Director】:
I see. But coordinating across different time zones and regulations seems challenging. What is your strategy to overcome these obstacles?
(なるほど。しかし、異なるタイムゾーンや規制を調整することは困難に思えます。これらの障害を克服するための戦略は何ですか?)
🧑‍🎓【Student / Clinical Research Manager】:
We will establish regional hubs in each area. Each hub will coordinate local sites, handle regulatory submissions, and communicate with headquarters weekly. This structure reduces delays and ensures consistency. We also utilize a unified digital platform for real-time data monitoring.
(各地域に地域ハブを設立します。各ハブは現地施設を調整し、規制申請を処理し、本社と週次で連絡を取ります。この構造は遅延を削減し、一貫性を確保します。また、リアルタイムデータモニタリングのために統一されたデジタルプラットフォームを活用します。)

👨‍💼【Teacher / Clinical Operations Director】:
That is a solid plan. One last question. How long will it take to launch this network?
(それは堅実な計画です。最後に1つ質問です。このネットワークを立ち上げるのにどれくらいかかりますか?)
🧑‍🎓【Student / Clinical Research Manager】:
We estimate 6 months for full deployment. The first 2 months will focus on site selection and contract negotiations. The next 3 months will cover staff training and system integration. The final month will be for validation and trial initiation.
(完全な展開には6か月と見積もっています。最初の2か月は施設選定と契約交渉に集中します。次の3か月は、スタッフトレーニングとシステム統合をカバーします。最後の1か月は、検証と治験開始のためのものです。)

👨‍💼【Teacher / Clinical Operations Director】:
Excellent. Your strategy addresses our key concerns. Let us proceed with the regional hub approach. Please submit a detailed timeline by next week.
(素晴らしい。あなたの戦略は我々の主要な懸念に対処しています。地域ハブアプローチで進めましょう。来週までに詳細なタイムラインを提出してください。)
3. Use  (4 min)|ロールプレイ & 実践(空欄補完)

Let's perform the role-play and fill in the blanks by translating the Japanese into English!
空欄の日本語を英語に訳しながら、ロールプレイを実践してみましょう!

Situation / シチュエーション(Reference again)

This involves discussing the construction of global networks with medical institutions worldwide for efficient implementation of international clinical trials.
世界各地の医療機関とのネットワーク構築を協議し、効率的なグローバル臨床試験実施体制を構築する場面です。

👨‍💼【Teacher / Clinical Operations Director】:
Thank you for meeting today. We need to accelerate our global trial network. Which regions do you recommend we prioritize for patient recruitment?
🧑‍🎓【Student / Clinical Research Manager】:
I recommend three regions. First, Eastern Europe offers strong recruitment capability at [適度な] cost. Second, Southeast Asia has large patient populations with diverse genetics. Third, North America ensures regulatory consistency with our headquarters.

👨‍💼【Teacher / Clinical Operations Director】:
That sounds reasonable. However, I am concerned about quality control across multiple sites. How do you assess each facility's research capability?
🧑‍🎓【Student / Clinical Research Manager】:
We evaluate three factors systematically. We [評価する] their previous trial completion rates, inspect their equipment and staff qualifications, and [モニターする] their patient retention records. Sites with completion rates above 90 percent are prioritized.

👨‍💼【Teacher / Clinical Operations Director】:
I see. But coordinating across different time zones and regulations seems challenging. What is your strategy to overcome these obstacles?
🧑‍🎓【Student / Clinical Research Manager】:
We will establish regional hubs in each area. Each hub will [調整する] local sites, handle regulatory submissions, and communicate with headquarters weekly. This structure reduces delays and ensures consistency. We also [活用する] a unified digital platform for real-time data monitoring.

👨‍💼【Teacher / Clinical Operations Director】:
That is a solid plan. One last question. How long will it take to launch this network?
🧑‍🎓【Student / Clinical Research Manager】:
We estimate 6 months for full deployment. The first 2 months will focus on site selection and contract negotiations. The next 3 months will cover staff training and system integration. The final month will be for [検証] and trial initiation.

👨‍💼【Teacher / Clinical Operations Director】:
Excellent. Your strategy addresses our key concerns. Let us proceed with the regional hub approach. Please submit a detailed timeline by next week.
4. Challenge (7 min)|応用実践

Let's perform the role-play and fill in the blanks by translating the Japanese into English!
空欄の日本語を英語に訳しながら、ロールプレイを実践してみましょう!

*Let's practice this part repeatedly until we can speak it smoothly.

  このパートはスムーズにスピーキングできるようになるまで繰り返し練習しましょう。

Situation / シチュエーション(Reference again)

This involves discussing the construction of global networks with medical institutions worldwide for efficient implementation of international clinical trials.
世界各地の医療機関とのネットワーク構築を協議し、効率的なグローバル臨床試験実施体制を構築する場面です。

👨‍💼【Teacher / Clinical Operations Director】:
Thank you for meeting today. We need to accelerate our global trial network. Which regions do you recommend we prioritize for patient recruitment?
🧑‍🎓【Student / Clinical Research Manager】:
[3つの地域をお勧めします。] First, Eastern Europe offers strong recruitment capability at moderate cost. Second, Southeast Asia has large patient populations with diverse genetics. Third, North America ensures regulatory consistency with our headquarters.

👨‍💼【Teacher / Clinical Operations Director】:
That sounds reasonable. However, I am concerned about quality control across multiple sites. How do you assess each facility's research capability?
🧑‍🎓【Student / Clinical Research Manager】:
[3つの要素を体系的に評価します。] [過去の治験完了率を評価し、設備とスタッフの資格を検査し、患者維持記録をモニターします。] Sites with completion rates above 90 percent are prioritized.

👨‍💼【Teacher / Clinical Operations Director】:
I see. But coordinating across different time zones and regulations seems challenging. What is your strategy to overcome these obstacles?
🧑‍🎓【Student / Clinical Research Manager】:
We will establish regional hubs in each area. [各ハブは現地施設を調整し、規制申請を処理し、本社と週次で連絡を取ります。] This structure reduces delays and ensures consistency. We also utilize a unified digital platform for real-time data monitoring.

👨‍💼【Teacher / Clinical Operations Director】:
That is a solid plan. One last question. How long will it take to launch this network?
🧑‍🎓【Student / Clinical Research Manager】:
We estimate 6 months for full deployment. The first 2 months will focus on site selection and contract negotiations. The next 3 months will cover staff training and system integration. The final month will be for validation and trial initiation.

👨‍💼【Teacher / Clinical Operations Director】:
Excellent. Your strategy addresses our key concerns. Let us proceed with the regional hub approach. Please submit a detailed timeline by next week.
\ If you have some extra capacity, give it a try(余力があればやってみましょう)/
5. Real-world application (5 min)|実務応用

Let's speak freely with the phrases and flow we learned today. If you can, imagine your real job—it makes practice more effective.
本日学習した単語やフレーズ、会話の流れを思い出しながら、自由に話してみましょう。可能であれば、自身の実務を想像しながら話すと効果的です。​

Situation / シチュエーション
You are discussing global clinical trial network strategy with your clinical operations director.
The director wants to understand your recommendations for regional site selection and coordination methods.
あなたは臨床運営ディレクターとグローバル治験ネットワーク戦略について協議しています。
ディレクターは、地域施設選定と調整方法に関するあなたの推奨事項を理解したいと考えています。

👨‍💼【Teacher / Clinical Operations Director】:
Please explain your approach to building our global trial network. I would like to understand your regional priorities and quality control methods.
(グローバル治験ネットワーク構築へのアプローチを説明してください。地域の優先順位と品質管理方法を理解したいと思います。)

🧑‍🎓【Student / Your Role】:
(Free Speaking based on today's lesson)

Hints / ヒント
1. Recommend priority regions for patient recruitment
2. Assess facility research capability systematically
3. Establish regional coordination structure
4. Estimate deployment timeline with phases
​※This is not a role-play. Please speak until you finish your thoughts.
 このパートはロールプレイ形式ではありません。最後まで通して話してみましょう。
6.  Wrap-up (2 min) |レッスンの振り返り

Let's review today's lesson with your teacher!
今日のレッスンについて講師と振り返ってみましょう!

 

6-1 Comments from student

・Good points / 良かったところ・上手くできたところ
・Things to work on / 今後強化したいところ

 

6-2 Feedback from teacher

・Good points / 良かった点
・Things to work on / 今後の強化ポイント
・What to review / 復習ポイント

 

*6-3 Questions from student (if any)

Japanese translation(日本語訳)

1. Read (2min)(型を学ぶ)|基本フレーズ

2. Try  (4min)(ロールプレイ練習)|型を使った練習
Let’s practice the role-play.
ロールプレイの練習をしましょう!

3. Use  (7min)|応用
Let’s perform the role-play and filling in the missing English!
英語を補完しながら、ロールプレイを実践してみましょう!

4. Challenge (7min)|実践
Let’s perform the role-play and filling in the missing English!
英語を補完しながら、ロールプレイを実践してみましょう!

5. Wrap-up (3min) – レッスンの振り返り

"Let’s review today’s lesson with your teacher!”

「今日のレッスンについて講師と振り返ってみましょう!」

5-1.  Comments from Student

  - Good points / 良かったところ・上手くできたところ

  - Things to work on / 今後強化したいところ

5-2.  Feedback from Teacher

  - Good points / 良かった点

  - Things to work on / 今後の強化ポイント

  - What to review / 復習ポイント

5-3. Question from Students (If any)

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