3.4 Records
The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies).
The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.
第 4 章、試驗主持人(INVESTIGATOR)
4.1 試驗主持人之資格與認定 4.1 Investigator's Qualifications and Agreements
4.1.1
試驗主持人合格與否應藉由教育、訓 練課程、和具備適當執行臨床試驗的 經驗來判定。除了需符合所有主管機 關規定的資格和能力，並且需提供試 驗委託者、人體試驗委員會\獨立倫理 委員會和主管機關最新的學經歷資 料或其他相關文件，以證明其符合試 驗主持人的資格。
4.1.1
The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).
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4.1.2
試驗主持人應完全熟悉試驗藥品在 試驗計畫書、最新主持人手冊、藥品 資訊及其他由試驗委託者提供的藥 品資訊中描述的使用方法。
4.1.2
The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.
4.1.3
試驗主持人應明瞭並遵從 GCP 和相 關主管機關的法規要求。
4.1.3
The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
4.1.4
試驗主持人\機構應接受試驗委託者 的監測與稽核，以及相關主關機關之 查核。
4.1.4
The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
4.1.5
試驗主持人應保留一份經其授權與 臨床試驗相關重要職務之合格人員 名單。
4.1.5
The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
4.2 適當的資源 4.2 Adequate Resources 4.2.1
試驗主持人應能(例如，依據回溯性資 料)證明其能在協議的時間內募集到 足夠的受試者。
4.2.1
The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.
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4.2.2
試驗主持人在協議的試驗期間內，應 有充分的時間適當執行和完成試驗。
4.2.2
The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
4.2.3
試驗主持人在試驗的預期時間內，應 有充分的合格
試驗相關人員及設施以適當並安全 的執行試驗。
4.2.3
The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.
4.2.4
試驗主持人應確保所有協助臨床試 驗的試驗相關人員對試驗計畫書及 試驗藥品有充分的了解，以及其於 臨床試驗中相關的責任和工作。
4.2.4
The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.
附錄 ADDENDUM
4.2.5
試驗主持人對授權於試驗中心執行 與試驗相關責任及功能之任何人或
任何一方，具有監督之責。
4.2.5
The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.
4.2.6
若試驗主持人\機構自他人或他方取 得執行與試驗相關職責及功能之服 務，試驗主持人及試驗機構應確保他 人或他方具備執行該責任及功能之 資格，並應採取一定措施，以確保與
4.2.6
If the investigator/institution retains the services of any individual or party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to
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試驗相關責任及功能之履行及數據 產生之完整性。
perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.
4.3 受試者的醫療照護 4.3 Medical Care of Trial Subjects 4.3.1
合格的醫生身為試驗主持人或試驗 協同主持人，應負責所有臨床試驗相 關的醫療決定。
4.3.1
A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.
4.3.2
在受試者參加試驗與後續追蹤期間，
試驗主持人\機構應確保對受試者任 何與試驗相關的不良反應，包括具臨 床意義之檢查數據等，提供充分的醫 療照護。當試驗主持人察覺試驗期間 受試者有疾病需要醫療照護時，必須 告知受試者。
4.3.2
During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.
4.3.3
若受試者有主要照護醫師且經受試 者同意，試驗主持人宜告知其主要照 護醫師該受試者參與臨床試驗。
4.3.3
It is recommended that the investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if
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the subject agrees to the primary physician being informed.
4.3.4
受試者得不附理由隨時退出退出臨 床試驗。
試驗主持人應在完全尊重受試者之 權利及意願之條件下，盡力確認其退 出試驗之原因。
4.3.4
Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.
4.4 與人體試驗委員會\獨立倫理委 員會之聯繫
4.4 Communication with IRB/IEC
4.4.1
試驗開始前，試驗主持人\機構應獲得 人體試驗委員會\獨立倫理委員會對 試驗計畫書、受試者同意書及其更新 版本、受試者招募程序(例如，廣告)，
及任何其他給予受試者的書面資料 之載明日期之書面同意。
4.4.1
Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.
4.4.2
試驗主持人\機構提供主持人手冊的 最新版本給人體試驗委員會\獨立倫 理委員會，為書面申請核准的程序之 一。如果主持人手冊在臨床試驗期間 更新，試驗主持人\機構應主動提供更 新的主持人手冊給人體試驗委員會\
獨立倫理委員會。
4.4.2
As part of the investigator's/institution's written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the investigator/institution should supply a copy of the updated Investigator's Brochure
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to the IRB/IEC.
4.4.3
試驗期間試驗主持人\機構應提供所 有相關文件資料以供人體試驗委員 檢閱。
4.4.3
During the trial the investigator/institution should provide to the IRB/IEC all documents subject to review.
4.5 遵從試驗計畫書 4.5 Compliance with Protocol 4.5.1
試驗主持人\機構應遵從經試驗委託 者、主管機關，及人體試驗委員會\獨 立倫理委員會同意的試驗計畫書執 行臨床試驗。 試驗主持人\機構與試 驗委託者 應共同簽署試驗計畫書或 另簽契約，以確認雙方的同意。
4.5.1
The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC. The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.
4.5.2
試驗主持人在未取得試驗委託者同 意及人體試驗委員會\獨立倫理委員 會核准前，不應偏離或變更試驗計畫 書的執行，但為及時避免受試者遭受 傷害或僅為行政事務之改變者，不受 此限。 (例如：監測者的改變、電話 號碼的改變)。
4.5.2
The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).
4.5.3 4.5.3
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試驗主持人或經其指定的試驗相關 人員，應紀錄並解釋執行試驗計畫書 的任何偏差。
The investigator, or person designated by the investigator, should document and explain any deviation from the approved protocol.
4.5.4
如為排除對受試者立即的傷害，試驗 主持人可不經人體試驗委員會\獨立 倫理委員會的批准\贊同而偏離或變 更試驗計畫書。但試驗主持人需盡快 將偏離或變更及其原因，或建議的試 驗計畫書修正案檢送與：
一、 人體試驗委員會\獨立倫理委員 會審查及批准\贊同的意見。
二、 試驗委託者同意 三、 主管機關。
4.5.4
The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
(a) to the IRB/IEC for review and approval/favourable opinion,
(b) to the sponsor for agreement and, if required,
(c) to the regulatory authority(ies).
4.6 試驗藥品 4.6 Investigational Product(s) 4.6.1
試驗主持人\機構須負責試驗機構中 試驗藥品的點收與使用紀錄。
4.6.1
Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.
4.6.2
試驗主持人\機構應\可指派專責藥師 或是在試驗主持人\機構監督下的適 當人選負責部份或全部試驗機構中 試驗藥品的點收與使用紀錄。
4.6.2
Where allowed/required, the investigator/institution may/should assign some or all of the investigator's/institution's duties for investigational product(s)
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accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution.
4.6.3
試驗主持人\機構及\被指定的專責藥 師或其他的適當人選，應保留試驗藥 品運送至臨床試驗機構及其存貨的 紀錄，以及每一個受試者使用試驗藥 品、未使用藥品歸還試驗委託者或另 外處置的紀錄。這些紀錄應包括日 期、數量、批序號、有效日期，及試 驗藥品和受試者的代碼。試驗主持人 應保留文件紀錄，說明其提供受試者 的劑量和試驗計畫書規定相符，且使 用的試驗藥品數量和由試驗委託者 收到的數量相吻合。
4.6.3
The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s).
These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
4.6.4
試驗藥品應依試驗委託者要求之方 式儲存（參閱 5.13.2、5.14.3），並應 符合相關法規要求。
4.6.4
The investigational product(s) should be stored as specified by the sponsor (see 5.13.2 and 5.14.3) and in accordance with applicable regulatory requirement(s).
4.6.5 4.6.5
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試驗主持人應確保試驗藥品僅得使 用於經核准之臨床試驗計畫。
The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol.
4.6.6
試驗主持人或由試驗主持人\機構指 定的人員，應向每一位受試者解釋如 何正確的使用試驗藥品，並應於臨床 試驗中每隔一段適當時間，檢查受試 者是否遵守說明。
4.6.6
The investigator, or a person designated by the investigator/institution, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.
4.7 隨機分配過程及盲性解碼
試驗主持人應遵從臨床試驗的隨機 分配程序，如可解碼，應確保依據試 驗計畫書規定解碼。如果臨床試驗採 盲性設計，而試驗藥品有任何提早解 碼的情況(例如，意外的解碼，嚴重不 良事件的解碼 )，試驗主持人應即時 對試驗委託者解釋，並作書面紀錄。
4.7 Randomization Procedures and Unblinding
The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only
The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only