TransCelerate - Pharmaceutical Research and Development



This document is a translation of a TransCelerate deliverable, which TransCelerate wrote in English. TransCelerate did not prepare this translation nor has it verified the accuracy or word usage of this translation. TransCelerate therefore disclaims any responsibility for any lack of accuracy or clarity or incorrect word usage contained in this translation.5041265-14478000Common Protocol Template v6.0About This TemplateDisclaimerThis document is a common protocol template. It contains sections marked as common text or text that may be used across protocols with little to no editing if the user chooses to do so. The use of this template is at the discretion of the user. Recommendations for modifications in future releases of the common protocol template can be submitted at any time and will be reviewed on a routine basis.These materials are provided 'AS IS' WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. TransCelerate and its members do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data, or for any indirect consequential loss whatsoever to any person using these materials or acting or refraining from action as a result of the information contained in these materials. Any party using these materials bears sole and complete responsibility for ensuring that the materials, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances, and comply with all applicable laws and regulations. Nothing in this template should be construed to represent or warrant that persons using this template have complied with all applicable laws and regulations. All individuals and organizations using this template bear responsibility for complying with the applicable laws and regulations for the relevant ponents of the Protocol TemplateThe Core Backbone contains protocol information common to all phases, study populations, and therapeutic areas. The core backbone is streamlined and focused on the sites’ needs. Libraries group and store content that will be inserted into the core backbone and contain specific information related to therapeutic area, study intervention, country, and study population (e,g,, patient, healthy volunteer). For pediatric or adult/pediatric studies, include the content contained in the pediatric library.Appendices provide additional information that can be accessed when needed (e.g., abbreviations, standard content regarding adverse event [AE] definitions).Core Backbone HeadingsLevel 1 and 2 headings should be consistent across protocols that use the TransCelerate Common Protocol Template (CPT) for reference and mapping purposes.Level 1 and 2 headings should not be deleted. If they are not relevant to the study, “Not applicable” should be inserted so that the numbering of subsequent sections is not changed.Level 3 and lower headings can be deleted/added/modified as needed with the exception of those in Section 8.3 relating to Adverse Events which are International Council on Harmonisation (ICH)/Regulatory Agency required wording and must be included.TerminologyThe following terminology has been selected for use within this template and is considered to be appropriate for all phases, study populations, and therapeutic areas.Participant is used rather than subject, healthy volunteer, or patient.Study intervention is used rather than study drug. Study intervention covers all types of investigational and non-investigational products including medical devices and vaccines.Study intervention is defined as investigational intervention(s), marketed product(s), placebo, or medical device(s) intended to be administered to a study participant per protocol.Formatting and Text ConventionsCommon Headings: Heading levels 1 and 2 should not be altered or deleted (indicate “not applicable” if needed).Suggested Headings: Heading levels 3 and lower are suggested and may be modified as necessary. Common Text: Black font preceded by <Start of common text> and followed by <End of Common Text> is common language intended to be harmonized across protocols. The recommendation is to use this text as written to maintain consistency across template users, but the text can be adapted if required. The flags for the start and end of common text can be removed automatically at the time of protocol finalization if the technology enabled CPT has been used or should be removed manually by the authorSuggested Text: Black text that is not flagged as common text is suggested language to be used in optional sections and can be deleted as needed.Variable Text: Blue bracketed text is variable text that should be addressed based on individual study needs.Example Text: Green italicized text is example text and should be removed by the author. Instructional Text: Red text is intended to aid in authoring of the protocol in this template. In the Basic Word Edition, it is red, hidden text, and paragraph marks must be enabled in order for it to be displayed. In the Technology Enabled Edition, it will appear only in the Instructional Text panel.表紙治験実施計画書標題:Protocol Title: The protocol should have a descriptive title that identifies the study design including type of blinding, study population, study intervention, and, if applicable, study intervention acronyms. The title should be similar to the Official Study Title in the Clinical Trials (CT) Registry disclosure guidance.治験実施計画書番号: 改訂版番号: ［改訂版番号］化合物[番号又は名称]: 開発相： -Please select one of the values for this field: N/A: for trials without phases (e.g., trials of devices or behavioral interventions) - Early Phase 1 - Phase 1: includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients - Phase 1/Phase 2: for trials that are a combination of phases 1 and 2 - Phase 2: includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks - Phase 2/Phase 3: for trials that are a combination of phases 2 and 3 - Phase 3: trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.- Phase 4: studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use簡易標題: Short title should be sufficiently detailed to make clear to a lay reader what the study is about and preferably suitable for use as the Brief Title in and for use with informed consents and ethics committee submissions. It should be limited to 300 characters.［略称］Acronym or abbreviation used publicly to identify the clinical study, if any. Limit: 14 characters. Delete if not applicable治験依頼者名: 所在地:The sponsor name and legal registered address must be included. In some countries, the clinical study sponsor may be the local affiliate company (or designee). If applicable, the details of the alternative sponsor and contact person in the territory should be provided to the relevant regulatory authority as part of the clinical study application and should not be included in the protocol.For device studies only: 製造業者: [製造業者名] Manufacturer is required for device protocols and may be deleted for other protocols. If the manufacturer is other than the sponsor, add manufacturer’s address.規制当局識別番号: Include all numbers that are applicable for the study and available at the time of protocol or amendment finalization ege.g., Investigational New Drug (IND) number (Include the Center Number, IND/IDE Number, Serial Number), World Health Organization (WHO) universal trial number, European Clinical Trials Database (EudraCT) number, , etc. Add type and number as applicable. [IND: EudraCT: NCT: WHO:EUDAMED:その他:]承認日: 治験依頼者署名：［氏名］［役職］日付メディカルモニターの氏名及び連絡先は［別途提供する］OR［XXに記載する］。Investigator Agreement Page is provided as a stand-alone document. The investigator should retain the original in the site study files and return a copy to the sponsor for archiving. This page is generated internally and provided alongside the protocol template. Each investigator should be sent a copy of it for completion. Signatures are obtained after sponsor has finalized and approved the protocol 治験実施計画書の改訂履歴一覧Delete this section if this is not an amendment.Protocols should not be developed with the intent to amend; however, if an amendment is required, the following process and template is recommended. Companies should modify this process as appropriate (e.g., naming conventions, designation of substantial/non-substantial amendment status) to ensure alignment with their internal processes and systems.GENERAL INSTRUCTIONS:Protocols should be amended by making the changes directly within the protocol.In addition to the Summary of Changes Table, incorporate the changes made as a result of the amendment into the respective CPT sections and createa new clean version a new version with the changes highlighted (i.e., "track changes") to be provided to the health authorities, if requiredFor substantial amendments: use the ‘track changes’ version of protocol to create a separate document with a tabular listing detailing section changed, initial wording, amended or new wording, reason/justification for change and reason for substantial amendmentInclude the heading: 'Protocol Amendment Summary of Changes' in the Table of Contents (TOC) as a non-numbered heading.Modify the Protocol Number as appropriate throughout the document as specific to the company (e.g., title page, page headers) to designate status as an amendment.See Appendix 10, Protocol Amendment History for further instructions and examples for completing this section.The common text section titled 'Document History' should be completed for each amendment.Amendments should appear in reverse chronological order with the most recent at the top (e.g.,?Amendment 3, 2, 1).The Protocol Amendment Summary of Changes Table for the current amendment should be maintained directly in front of the TOC.The Protocol Amendment Summary of Changes Table for the previous amendment(s) should be moved to Appendix 10, Protocol Amendment History.Group changes by rationale and list rationales by order of importance, with the rationale for the most important study design changes listed first. Under each rationale, list changes in order of occurrence in the protocol.Relevant changes may have been made to the protocol template since the original protocol or last amendment was issued. Check the template change control documentation and discuss with the team to ensure all relevant changes have been added to the protocol and included in the Protocol Amendment Summary of Changes. Table NAMING CONVENTIONS for differentiation of types of amendments (e.g., global, country-specific, sitespecific):Use International Organization for Standardization (ISO)-Alpha 3 Codes from United Nations Statistics Department for 3-letter codes to represent country or area name in country-specific amendments: Examples can be found in Appendix 10, Protocol Amendment History.NUMBERING CONVENTIONSGlobal Amendments should be sequentially numbered (e.g., Amendment 1, Amendment 2, Amendment 3, etc.).Country-specific amendments should list the 3 digit ISO-Alpha 3 Codes (link above) with sequential numbering (e.g., for France, the 3-digit code is FRA. The first country-specific amendment for France should be numbered Amendment FRA-1. If a 2nd amendment is required with content specific to France, it would be Amendment FRA-2.).When adding an amendment ensure that the country-specific changes are maintained with each global update,A country-specific amendment to a global amendment orA global amendment to a country-specific amendment.Examples can be found in Appendix 10, Protocol Amendment History.DOCUMENT HISTORYThe Document History table should be inserted at the beginning of each amendment and contain the Document Number and Date for each amendment.Global amendments should not list the country- or site-specific amendments in the table.Country-and site-specific amendments should list the global amendments.Country-specific amendments should not list the site-specific amendments.Site-specific amendments should not list country-specific amendments unless they are for that specific country.If an amendment with identical changes is needed for multiple countries/areas/sites, they may be named as Region 1 (list country/area codes from ISO-Alpha 3 Codes from United Nations Statistics Department as noted above)Region 2 (list country/area codes from ISO-Alpha 3 Codes from United Nations Statistics Department as noted above)Site-specific SS-1 (Sites Numbers)The rationale for not including the entire list of amendments in the Document History table is that the global amendments apply to all countries and sites, while the country- and site-specific amendments are just that, ‘specific,’ and therefore do not apply to all.Examples can be found in Appendix 10, Protocol Amendment History.List dates of original protocol and all amendments in reverse chronological order.<Start of common text>改訂履歴一覧版番号承認日[Amendment X][Day-Mon-Year][Amendment X][Day-Mon-Year][Amendment X][Day-Mon-Year]Original Protocol[Day-Mon-Year]改訂第［X］版：　　　　年　月　日Include the following statement if this amendment will be implemented in any European Union (EU) Member State.This amendment is considered to be [substantial] [nonsubstantial] based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union [because it neither significantly impacts the safety or physical/mental integrity of participants nor the scientific value of the study].Include the last phrase for non-substantial amendments only.主な改訂理由:［改訂理由を記載］The overall rationale (one primary driver) for the changes implemented in the protocol amendment should be provided. In addition, provide a high-level description of the change(s) and a brief scientific rationale for specific items outlined in the table below (e.g., changes to individual inclusion/exclusion criteria). See Appendix 10, Protocol Amendment History for examples of format and green text for sample content. [INSERT Rationale Statement]項目番号及び見出し改訂内容改訂理由の概要<End of common text>目次 TOC \o "1-3" \h \z \u 1.治験実施計画書の概要 PAGEREF _Toc1492344 \h 121.1.要約 PAGEREF _Toc1492345 \h 121.2.治験概略図 PAGEREF _Toc1492346 \h 151.3.治験実施スケジュール PAGEREF _Toc1492347 \h 162.緒言 PAGEREF _Toc1492348 \h 192.1.本治験の実施根拠 PAGEREF _Toc1492349 \h 192.2.背景 PAGEREF _Toc1492350 \h 192.3.ベネフィット?リスク評価 PAGEREF _Toc1492351 \h 202.3.1.リスク評価 PAGEREF _Toc1492352 \h 212.3.2.ベネフィット評価 PAGEREF _Toc1492353 \h 222.3.3.ベネフィット?リスクに関する結論 PAGEREF _Toc1492354 \h 223.目的及び評価項目 PAGEREF _Toc1492355 \h 234.治験デザイン PAGEREF _Toc1492356 \h 254.1.治験デザインの概要 PAGEREF _Toc1492357 \h 254.2.治験デザインの科学的根拠 PAGEREF _Toc1492358 \h 254.2.1.治験デザインへの患者の意見 PAGEREF _Toc1492359 \h 264.3.用量設定の根拠 PAGEREF _Toc1492360 \h 264.4.治験終了の定義 PAGEREF _Toc1492361 \h 265.治験対象集団 PAGEREF _Toc1492362 \h 285.1.選択基準 PAGEREF _Toc1492363 \h 285.2.除外基準 PAGEREF _Toc1492364 \h 305.3.生活習慣に関する考慮事項 PAGEREF _Toc1492365 \h 305.3.1.食事及び食事制限 PAGEREF _Toc1492366 \h 305.3.2.カフェイン、アルコール及びタバコ製品 PAGEREF _Toc1492367 \h 315.3.3.活動 PAGEREF _Toc1492368 \h 315.4.スクリーニング脱落 PAGEREF _Toc1492369 \h 326.治験薬 PAGEREF _Toc1492370 \h 336.1.治験薬の投与 PAGEREF _Toc1492371 \h 336.1.1.医療機器 PAGEREF _Toc1492372 \h 356.2.調製／取扱い／保管／管理 PAGEREF _Toc1492373 \h 366.3.バイアス最小化策：ランダム化及び盲検化 PAGEREF _Toc1492374 \h 376.4.服薬／投薬遵守 PAGEREF _Toc1492375 \h 406.5.併用療法 PAGEREF _Toc1492376 \h 406.5.1.レスキュー薬 PAGEREF _Toc1492377 \h 416.6.用量変更 PAGEREF _Toc1492378 \h 426.6.1.再投与の基準［該当する場合］ PAGEREF _Toc1492379 \h 436.7.治験終了後の治療 PAGEREF _Toc1492380 \h 437.治験薬の投与中止及び被験者の治験中止?脱落 PAGEREF _Toc1492381 \h 447.1.治験薬の投与中止 PAGEREF _Toc1492382 \h 447.1.1.治験薬の投与中断 PAGEREF _Toc1492383 \h 457.1.2.再投与 PAGEREF _Toc1492384 \h 457.2.被験者の治験中止?脱落 PAGEREF _Toc1492385 \h 457.3.追跡不能 PAGEREF _Toc1492386 \h 458.治験の評価と手順 PAGEREF _Toc1492387 \h 478.1.有効性評価 PAGEREF _Toc1492388 \h 488.2.安全性評価 PAGEREF _Toc1492389 \h 498.2.1.理学的診察?検査 PAGEREF _Toc1492390 \h 498.2.2.バイタルサイン PAGEREF _Toc1492391 \h 508.2.3.心電図（ECG） PAGEREF _Toc1492392 \h 508.2.4.臨床検査の安全性評価項目 PAGEREF _Toc1492393 \h 528.2.5.自殺念慮及び自殺関連行動のリスクモニタリング PAGEREF _Toc1492394 \h 538.3.有害事象及び重篤な有害事象 PAGEREF _Toc1492395 \h 548.3.1.有害事象及び重篤な有害事象情報の収集期間及び頻度 PAGEREF _Toc1492396 \h 558.3.2.有害事象及び重篤な有害事象の調査方法 PAGEREF _Toc1492397 \h 558.3.3.有害事象及び重篤な有害事象の追跡調査 PAGEREF _Toc1492398 \h 558.3.4.重篤な有害事象の規制上の報告要件 PAGEREF _Toc1492399 \h 568.3.5.妊娠 PAGEREF _Toc1492400 \h 568.3.6.心血管系事象及び死亡 PAGEREF _Toc1492401 \h 578.3.7.有害事象又は重篤な有害事象に該当しない、疾患関連事象とその転帰 PAGEREF _Toc1492402 \h 578.3.8.特に注目すべき有害事象 PAGEREF _Toc1492403 \h 578.3.9.医療機器の不具合 PAGEREF _Toc1492404 \h 578.4.過量投与の治療 PAGEREF _Toc1492405 \h 598.5.薬物動態（PK） PAGEREF _Toc1492406 \h 598.6.薬力学 PAGEREF _Toc1492407 \h 618.7.遺伝学 PAGEREF _Toc1492408 \h 618.8.バイオマーカー PAGEREF _Toc1492409 \h 618.9.免疫原性評価 PAGEREF _Toc1492410 \h 638.10.［医療経済］［医療資源の活用と医療経済］ PAGEREF _Toc1492411 \h 639.統計学的考察 PAGEREF _Toc1492412 \h 659.1.統計学的仮説 PAGEREF _Toc1492413 \h 659.2.被験者数の決定 PAGEREF _Toc1492414 \h 659.3.解析対象集団 PAGEREF _Toc1492415 \h 669.4.統計解析 PAGEREF _Toc1492416 \h 669.4.1.一般的な考慮事項 PAGEREF _Toc1492417 \h 669.4.2.主要評価項目 PAGEREF _Toc1492418 \h 679.4.3.副次評価項目 PAGEREF _Toc1492419 \h 679.4.4.三次／探索的評価項目 PAGEREF _Toc1492420 \h 679.4.5.その他の安全性解析 PAGEREF _Toc1492421 \h 679.4.6.その他の解析 PAGEREF _Toc1492422 \h 679.5.中間解析 PAGEREF _Toc1492423 \h 689.6.データモニタリング委員会 PAGEREF _Toc1492424 \h 6810.補助資料及び実施上の考慮事項 PAGEREF _Toc1492425 \h 6910.1.別添1：規制、倫理及び治験管理上の考慮事項 PAGEREF _Toc1492426 \h 6910.1.1.規制及び倫理上の考慮事項 PAGEREF _Toc1492427 \h 6910.1.2.Financial Disclosure PAGEREF _Toc1492428 \h 6910.1.3.同意取得手順 PAGEREF _Toc1492429 \h 7010.1.4.データの保護 PAGEREF _Toc1492430 \h 7110.1.5.委員会の構成 PAGEREF _Toc1492431 \h 7110.1.6.治験データの配布 PAGEREF _Toc1492432 \h 7110.1.7.データの品質保証 PAGEREF _Toc1492433 \h 7210.1.8.原資料 PAGEREF _Toc1492434 \h 7210.1.9.治験及び実施医療機関における治験の開始及び終了 PAGEREF _Toc1492435 \h 7310.1.10.公表に関する方針 PAGEREF _Toc1492436 \h 7410.2.別添2：臨床検査 PAGEREF _Toc1492437 \h 7410.3.別添3：有害事象：定義並びに記録、評価、追跡調査及び報告の手順 PAGEREF _Toc1492438 \h 7810.3.1.有害事象の定義 PAGEREF _Toc1492439 \h 7810.3.2.重篤な有害事象の定義 PAGEREF _Toc1492440 \h 7910.3.3.有害事象及び／又は重篤な有害事象の記録及び追跡調査 PAGEREF _Toc1492441 \h 8010.3.4.重篤な有害事象の報告 PAGEREF _Toc1492442 \h 8210.4.別添4：避妊ガイダンス及び妊娠情報の収集 PAGEREF _Toc1492443 \h 8410.5.別添5：遺伝学 PAGEREF _Toc1492444 \h 8710.6.別添6：肝事象発現後に推奨される措置及び追跡調査［及び投与再開／再投与に関するガイドライン］ PAGEREF _Toc1492445 \h 8810.7.別添7：有害事象（AE）、医療機器による有害作用（ADE）、重篤な有害事象（SAE）及び医療機器の不具合：定義並びに記録、評価、追跡調査及び報告の手順 PAGEREF _Toc1492446 \h 8910.7.1.有害事象及び医療機器による有害作用の定義 PAGEREF _Toc1492447 \h 8910.7.2.重篤な有害事象、医療機器による重篤な有害作用及び予測できない重篤な有害作用 PAGEREF _Toc1492448 \h 8910.7.3.医療機器の不具合の定義 PAGEREF _Toc1492449 \h 9010.7.4.有害事象及び／又は重篤な有害事象及び医療機器の不具合の記録及び追跡調査 PAGEREF _Toc1492450 \h 9010.7.5.重篤な有害事象の報告 PAGEREF _Toc1492451 \h 9210.7.6.医療機器による重篤な有害作用の報告 PAGEREF _Toc1492452 \h 9310.7.7.有害事象、医療機器による有害作用、重篤な有害事象、医療機器による重篤な有害作用の判定フローチャート PAGEREF _Toc1492453 \h 9410.8.別添8：各国特有の記載事項 PAGEREF _Toc1492454 \h 9510.9.別添9：略語 PAGEREF _Toc1492455 \h 9610.10.別添10：治験実施計画書の改訂履歴 PAGEREF _Toc1492456 \h 9711.引用文献 PAGEREF _Toc1492457 \h 100治験実施計画書の概要要約The protocol synopsis is a short (1 to 2 pages) summary of the key points of the protocol. This section of the protocol should be completed after the main text to ensure consistency with the main text.The purpose of the protocol synopsis is to provide a concise outline of the key aspects of the study. It may be used for European Union (EU) Clinical Trial Applications (CTA) and for other external bodies such as Institutional Review Boards [IRB]/Independent Ethics Committees [IEC]). Its level of detail should not dissuade/discourage the investigator from referring to the main text of the protocol.治験実施計画書標題： 簡易標題：本治験の実施根拠：The synopsis text should be taken from the main text.目的及び評価項目：State the primary and key secondary objectives and associated endpoints. Be consistent with the main text of the protocol in text and format. Endpoints: This should be a high-level description.目的［Estimands／評価項目］主要副次治験デザイン：Be sure the text included in this section is consistent with the text in other sections such as inclusion/exclusion criteria and concomitant medications.Briefly state:Type of design (e.g., parallel, crossover, single group) and control method (e.g., placebo, active comparatr, low dose, historical, or none [uncontrolled]), single or multicenter. Include the kind of control group to be used, if any.High-level description of the study population (e.g., healthy volunteers, patients with acute lung injury, etc.).Level and method of blinding (e.g., open-label, single-blind, double-blind, double-blind [sponsor unblinded], matching placebo, double-dummy) and the methods to be used to minimize bias on the part of subjects, investigators, and analysts.Study intervention assignment method (e.g., randomization, stratification, both). Do NOT state block size. If assignment to intervention is by randomization, describe when randomization occurs relative to screening.Refer to use of an Independent Data Monitoring Committee, Dose Escalation Committee, or similar review group.治験の説明（開示用）：［本治験は［主目的］を目的とした、［治験モデル］、［XXXを盲検化／マスキングした］［数字］群で実施する試験である。］Complete this statement with values for each of the indicated fieldsExample: This is a parallel group treatment study with 2 arms that is participant and investigator blinded.Intervention Model: Single Group: Clinical trials with a single arm Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the studyCross-over: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the studyFactorial: Two or more interventions, each alone and in combination, are evaluated in parallel against a control groupSequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studiesPrimary Purpose: Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition. Prevention: One or more interventions are being assessed for preventing the development of a specific disease or health condition. Diagnostic: One or more interventions are being evaluated for identifying a disease or health condition.Supportive Care: One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.Screening: One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor.Health Services Research: One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.Basic Science: One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).Device Feasibility: An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.Other: None of the other options applies.Number of Arms – Numeric value for the number of arms in the study Masking: Enter all that apply or 'No Masking': Participant Care Provider?? Investigator Outcomes Assessor: the individual who evaluates the outcome(s) of interest No masking被験者数：State the expected number of participants to be randomized. If an event driven trial, state the number of events planned along with the number of participants randomized.Ensure evaluable is clearly defined and cross reference Section 9 Statistical Considerations, if applicable.Cross reference Section 9.2 Sample Size Determination and ensure that section clearly explains how screening failures and non-evaluable participants are defined.Choose one of the two options listed and modify as appropriate < Start of suggested wording>各投与群の評価可能例数として約［X］例ずつ、合計約［X］例を得るために、［ランダム化症例／組入れ症例］を確保する。そのために、約［X］例の被験者をスクリーニングする。OR評価可能な治験完了例として約［X］例を得るために、最大［X］例の被験者を［ランダム化する／組み入れる］。注意：同意取得の手順を完了し、被験者本人又は法定代理人が治験への参加に同意したことを「組入れ」と定義する。ただし、治験参加の適格性を確認する目的でスクリーニングを受けたが、治験に参加しない被験者は、治験実施計画書に規定がない限り組入れ症例とみなさない。< End of suggested wording>投与群及び治験期間：Briefly state:Total duration of study participation for each participant with sequence and duration of study periods (e.g., screening, run-in, fixed dose/titration, follow up/washout periods)Dose regimens in each study period and stage (if applicable) including frequency (e.g., twice daily) and route of administration and criteria for individualized dosing (e.g., participant weight or plasma concentrations), if applicableRules/procedures for any dose changes/adjustments including flexible dosing; dose reductions, interruptions, or tapering; temporary/definitive discontinuation; and any circumstances for resuming study intervention, as applicableデータモニタリング委員会の設置：［あり／なし］Use of an Independent Data Monitoring Committee, Dose Escalation Committee, or similar review group治験概略図治験実施スケジュールGeneral information:Ensure that only essential data are collected. The Schedule of Activities (SoA) is the primary location for specifying the timing of assessments at each stage of the study. Do not repeat the SoA schedule in the main text.Visit windows may be necessary for the collection of efficacy or safety data. The acceptable windows can be indicated on the SoA by adding ± days to the Visit Day row. If applicable, specify the order of assessments (e.g.,?performing participant-recorded assessments before other assessments to reduce bias or performing electrocardiograms [ECG] or measuring vital signs before blood draws).Notes/footnotes (relating to specific procedures) should be minimal, brief, and include key information. If additional details are needed, the notes should refer to the section in the protocol main text where details are provided. Note that Day 0 should not be used as a time point. Combine assessments on consecutive weeks if they are identical and consider separate tables for separate phases of the study (e.g.,?screening, intervention days, and follow-up). For a multiple part study, one SoA table for each part of the study is recommended.An example of a SoA table is included. Modify as required.手順スクリーニング（Day 1前［X］日以内）投与期間［日、週等］早期中止後観察（最終投与後［X］日間）備考–112345678同意取得X選択及び除外基準X［ランダム化及び／又は治験薬の初回投与前に臨床状態を再確認する。］人口統計学的特性X理学的診察?検査（身長?体重を含む）X病歴（嗜好品の使用［及び若年性心血管疾患の家族歴］を含む）X嗜好品：［薬物、アルコール、タバコ、カフェイン］既往歴?合併症X［血清又は尿］妊娠検査（妊娠可能な女性のみ）X［B型及びC型肝炎スクリーニング］X臨床検査（肝機能検査を含む）XXXX12誘導心電図XXXXXバイタルサインXXXXXXXXXX［ランダム化］（if applicable）X遺伝学的研究用検体X [Pre-dose/baseline], ICF for genetic sampling should be added per sponsor process (e.g., part of ICF or separate ICF).治験薬XX有害事象の評価X=============================重篤な有害事象の評価X=============================XX［医療機器の不具合］（if applicable）X=============================X併用薬?併用療法の確認X=============================XX［治験特有の評価（PK、有効性等）］緒言Overall, this section should be short (recommend 2 to 3 pages) and may be started with an overview description of the study intervention, its class, and intended use as well as the study population.Consider that the entire protocol will be subject to public disclosure and be succinct.As much as possible, reference the Investigator’s Brochure, package insert, and other relevant documents; do not duplicate information available elsewhere.Example text:XXX is a novel, potent, and selective long-acting inhaled β2 adrenoreceptor agonist that is being developed for once-daily treatment of asthma and COPD.End of example text:本治験の実施根拠Present a 2 to 3 sentence, coherent, scientific description of the rationale for the study with respect to the purpose of the study. The rationale for the study design appears in Section 4.2.Include a brief description of the reasons for doing the study (the aim of the study) and for doing it at this time. For example, include any key issues for the compound which are being addressed (e.g., variable exposure addressed with a new formulation or dosing with food).For device studies, include populations and indications for which the investigational device is intendedThis section should be aligned with the overall development plan for the compound.This rationale should be based on the results of previous studies (if relevant) and the characteristics of the disease entity and should be of scientific merit. 背景This section should be brief (1/2 to 1 page) as the majority of the information is available in existing documents. Include a 1 to 2 sentence description of why the study intervention is being developed for the disease (e.g, unmet medical need, easier administration, better efficacy expected, better side effect profile). State whether this is a novel class of compounds or a new compound within an established class, and whether this class of compounds has been used before in the therapeutic area. Briefly refer to literature and data relevant to the study.For studies using an unlicensed study intervention: Include a very brief summary of key preclinical/clinical data relevant to the development of the compound and pharmacodynamic/efficacy findings that support development for the indication. Do not duplicate data already summarized in the Investigator’s Brochure; a reference to the specific Investigator’s Brochure section is sufficient. When referencing information in the Investigator’s Brochure, provide a reference to the section or table where the data are presented.For studies using marketed compounds or comparators: See the manufacturer’s label (include as a reference in Section 11) or provide a brief description of relevant information. To avoid copyright infringements, do not include a copy of the approved product label in the protocol.Example text:Antibiotic resistance has been widely publicized and poses a serious threat to public health worldwide. Research efforts in recent years have become increasingly geared towards discovering and developing new classes of antibiotics with modes of action distinct from those of established agents and activity against resistant strains.[Study intervention name] belongs to a novel structural class of antibiotics: bacterial type II topoisomerase inhibitors (BTIs). The BTIs selectively inhibit bacterial DNA gyrase and topoisomerase IV (homologous type II topoisomerases), which are clinically-validated antibacterial targets inhibited by the quinolone family of antibiotics. The BTIs and quinolones bind to a similar region of the same target proteins; however, they recognize distinctly different amino acids. Therefore, they inhibit different stages of the catalytic cycle of the target proteins.A?detailed description of the chemistry, pharmacology, efficacy, and safety of [study intervention name] is provided in the [Investigator’s Brochure/package insert].End of example text:ベネフィット?リスク評価Provide a brief assessment of the benefits and risks of study participation. Information should align with the Investigator’s Brochure, package insert/prescribing information (if applicable), Investigational Directions for Use (IDFU) (for a device product) and Investigational Medicinal Product Dossier (IMPD) (if applicable).Consider the known and expected benefits and potential risks of the study intervention(s), any significant risks associated with study procedures (biopsies, etc.) or design (placebo arm, etc.), and any measures to control the risks. Cross reference Section 4 Study Design for details of study procedures, dose, and study design justification. For an investigational device include risk/benefit analysis from Device Risk Analysis report and details of anticipated serious adverse device effects.The benefit/risk assessment may include a description of the types of events anticipated in the specific study population (e.g., hypoglycemic events are anticipated in a Type-1 diabetes participant, and arrhythmias are anticipated in a participant with Class III/IV heart failure).Outcomes of discussions with regulatory authorities as related to benefit/risk and reporting may be summarized here if it provides useful insights for the investigator. <Start of Suggested text>［治験薬名］の既知及び予想されるベネフィットとリスク、並びに合理的に予想される有害事象の詳細は、［治験薬概要書／被験者向け説明資料／添付文書／治験安全性最新報告／製品概要及び／又は医療機器の使用説明書］に示す。<End of Suggested text>リスク評価臨床的に重要な潜在的リスクBriefly summarize only the relevant key risks for THIS studyリスクと判断したデータ／根拠の概略For applicable cells in this column, include a brief description or reference to IB Section [X].Consider the guidance in the DSUR Evaluation of Risks Section 18.1 when taking an inventory of potential risk topics.リスク軽減策For applicable cells in this column, provide a brief description of strategies to mitigate identified risks or provide a cross reference to the relevant protocol Section (e.g. inclusion/exclusion criteria, participant monitoring, withdrawal criteria, dose selection, comparison to nonclinical no effect levels, duration of dosing, etc.).治験薬［X］Nonclinical Risks – concluding sections of the Non-Clinical Assessment of Safety (NCAS) should provide key nonclinical risks associated with the IPClinical Risks – consider DSUR (or GDS text for marketed product) for key clinical risksAlso consider the IB, Development Core Safety Information (DCSI), IDFU and BRMP as applicable. If applicable, include non-Serious Adverse Events (SAEs) of special interest. Cross reference Section 8.3if appropriate治験の手順 Consider risks associated with the study design and procedures.その他Consider risks associated with comparators, challenge agents, imaging agents, medical devices, etc.ベネフィット評価The benefit assessment should be written from the perspective of an individual participant.Benefit considerations may include:Potential benefit of receiving study intervention during study duration that may have clinical utility (if applicable)Contributing to the process of developing new therapies in an area of unmet need – this may be particularly relevant for Clinical Pharmacology studiesProvision of non-drug therapy (e.g. compression stockings) if applicableMedical evaluations/assessments associated with study procedures [e.g. physical exam, ECG, Labs, etc.]ベネフィット?リスクに関する結論Provide a succinct concluding statement on the perceived balance between risks that have been identified from cumulative safety data, protocol procedures and anticipated efficacy/benefits within the context of the proposed study. Risks need to be weighed against the benefits for the individual participant.<Start of example text>Example wording: Taking into account the measures taken to minimize risk to participants participating in this study, the potential risks identified in association with [study intervention] are justified by the anticipated benefits that may be afforded to participants with [indication]. <End of example text>目的及び評価項目Objectives and endpoints for specific therapeutic areas may be accessed in the therapeutic area libraries.In a trial designed to establish efficacy, a primary endpoint should measure a clinically meaningful therapeutic effect or be a surrogate or other endpoint with a demonstrated ability to predict clinical benefit.List each scientific objective of the study, clearly and concisely, differentiating between primary and secondary objectives. The objectives should present the questions that the study is designed to answer (which can include predefined safety parameters). Secondary objectives should not merely reiterate the secondary endpoints of the study. Ensure that there is an endpoint for each study objective including exploratory objectives, if applicable, and that there are no endpoints without a corresponding objective.Keep endpoint information at a high level with details placed in Section 8: Study Assessments and Procedures and/or Section 9: Statistical Considerations. Describe each endpoint (e.g., safety and tolerability as determined by AE reporting, vital signs, and ECG instead of just safety and tolerability) stating evaluation timepoints but include the specific methodology that will be used in Section 8.Consider whether the desired endpoints will be achievable in case of unexpected findings, technical/equipment issues, or personnel failure.Tertiary/exploratory objectives may be added to indicate that other assessments will be made to help future research if taking additional samples for these endpoints; otherwise, reference the statistical analysis plan (SAP) for the list of other assessments. These should be kept to a minimum to focus the study on primary objectives. Note that exploratory objectives will not be listed on the website.If a clinical outcome assessment (COA) is included in the study, mention the concept being measured (e.g.,?fatigue) as well as the instrument (e.g., the impact of study intervention name on fatigue as measured by the fatigue scale in the Functional Assessment of Cancer Therapy-Anemia [FACT-An]. Avoid the term quality of life and use a more specific term such as physical functioning or vitality.If additional endpoints (e.g., pharmacodynamic endpoints) may be explored, consider addition of a general statement giving an indication of the types of endpoints that might be explored. For example, in cardiovascular studies, a statement such as “Additional atherosclerotic biomarkers may be explored.” may be appropriate. The study procedures section of the protocol should clarify, to the extent possible, how and when the additional endpoints will be selected, the types of endpoints that may be assayed (e.g., protein, messenger ribonucleic acid), whether existing or additional samples would be used for these assays, and how any changes to exploratory endpoints will be documented.Identify surrogate markers if used as study endpoints.It is recommended that objectives and endpoints be presented together in a table (see example) to ensure all endpoints are aligned with an objective. The format of the table can be adapted for multiple part studies.The objectives should be stated with sufficient specificity that the reader can easily understand the intended context (e.g. Superiority of intervention [X] vs. control when the intervention is taken as directed). Avoid objectives that use vague terms such as assess or evaluate. Objective text should link to the statistical output (e.g., compare, estimate). Consultation or review by a statistician is recommended. Estimands include four attributes: the population, variable (or endpoint), details of how to account for intercurrent events and the population-level summary for the variableThe estimands stated in the table below should be clear and include sufficient detail on each attribute. Estimands are mandatory for confirmatory studies, but it is also recommended to include estimands in other types of studies due to transparencyAn estimand description is not required for tertiary/exploratory objectives or for core Phase 1 protocols. Refer to Section 9.1 for additional guidance. 目的［Estimands／評価項目］主要副次三次／探索的治験デザイン治験デザインの概要Do not include study schema Do not include the SoA here.Use bullets rather than lengthy text, if possible.Include a brief summary of the study design (e.g., parallel, crossover, single group) and control method (e.g., placebo, active comparator, low dose, historical, or none [uncontrolled]), single or multicenter. Include the kind of control group to be used, if anye.g., High-level description of the study population (e.g., healthy volunteers, patients with acute lung injury, etc.).Level and method of blinding (e.g., open-label, single-blind, double-blind, double-blind [sponsor unblinded], matching placebo, double-dummy), and the methods to be used to minimize bias on the part of subjects, investigators, and analysts.Study intervention assignment method (e.g., randomization, stratification, both). Do NOT state block size. If assignment to intervention is by randomization, describe when randomization occurs relative to screening. Do not put sample size justification here. This is covered in Section 9 Statistical Considerations.Refer to any use of an Independent Data Monitoring Committee, Dose Escalation Committee, or similar review group and cross reference Section 9.6 total duration of study participation for each participant with sequence and duration of study periods (e.g., screening, run-in, fixed dose/titration, follow up/washout periods)Describe any provisions for extending the study or entry to roll-over studies (cross reference Section 6.7 Intervention after the End of the Study). Do not duplicate information.See therapeutic area libraries for additional guidance for studies in specific therapeutic areas.A protocol deviation is related to a data point or process identified in the protocol or documents referenced in the protocol (e.g., laboratory manual). When designing the study, limit items that may generate deviations whenever possible. Reduce the number of reference documents to those essential for the conduct of the study治験デザインの科学的根拠Provide scientific rationale for any features of the study design and chosen control. Include any key ethical issues. Do not reiterate the details provided in the Investigator’s Brochure or other documents. Describe why the primary endpoint is clinically relevant and how it provides a reliable and valid measurement of the intended treatment effect.Discuss how the primary endpoint measures direct benefit in how the participant feels, functions or survives and what would constitute a clinically meaningful effect. If a measure of direct benefit is not proposed, describe how a proposed surrogate endpoint substitutes for how a participant feels, functions or survives, based on epidemiologic, therapeutic, pathophysiologic or other evidence to predict benefit.If applicable, provide a scientific rationale that including a vulnerable study population (e.g., pediatric participants or participants requiring emergency care) has the potential to produce a clinically relevant benefit.Provide justification for the gender and age allocation of subjects and if a specific gender or age group is excluded from or underrepresented in the study, an explanation of the reasons and justification for these exclusion criteriaIf an Auxiliary Medicinal Product (AMP) or Non Investigational Medicinal Product (NIMP)/diagnostic agent to be utilized in the study is a marketed compound but is not used as per the approved label, a justification needs to be added in the protocol for the intervention to still be classified as NIMP/AMP.治験デザインへの患者の意見Describe any participant involvement in the design of the clinical trial and any participant suggestions implemented.用量設定の根拠Provide justification for the selection of the doses of all study interventions. Cross reference Section 6.6 Dose Modification as needed.For a device product, state the rationale for the proposed route of administration (e.g., injection plane or technique, method of implantation) for each study intervention and provide justification for its selection. Consider adding this suggested wording.<Start of suggested wording>本医療機器の治験では「用量」の代わりに［適切な語句を挿入］とする。<End of suggested wording>治験終了の定義<Start of suggested wording>［最終来院］又は［治験実施スケジュールで定められた最後の治験手順］を含め、治験のすべての段階を完了した被験者を、治験を完了したとみなす。Distinguish between the end of the study (EU definition) and study completion (US CT Registry definition: Final date on which data were or are expected to be collected) if they are not the same.治験の終了日とは、［最後の被験者の最終来院／全被験者中の最後の被験者の治験実施スケジュールで定められた最後の治験手順実施］の日と定義する。<End of suggested wording>治験対象集団<Start of common text>治験実施計画書で規定されている組入れ基準からの逸脱を事前に認めること、すなわち治験実施計画書の不履行や適用除外は認められない。<End of common text>選択基準General Points:List the criteria necessary for participation in the study. Ensure that each criterion can be easily assessed on the basis of measurable data and answered with yes/no responses.When choosing inclusion criteria, consider that study participants should be representative of the participant population to which the results will be generalized.The choice of the study population in a Phase 2 or Phase 3 clinical trial should reflect the intended use of the drug. This is particularly relevant for planning multiregional trials and for the range of subgroups that may be relevant to evaluate. If measures to enrich the study population for prespecified subgroups of interest are used, they should be described here.In general, laboratory results required for eligibility should be listed as inclusion criteria rather than exclusion criteria.The use of double negatives should be avoided (e.g., no indication of prior noncompliance with the intervention regimen).以下の基準をすべて満たす場合のみ、治験の組入れ対象とする。年齢<Start of suggested text>同意説明文書（ICF）への署名時の年齢が［18］歳以上［X］歳以下の被験者。<End of suggested text>対象被験者及び疾患特性For studies in healthy volunteers, begin with this criterion. State whether rescreening will be allowed and the circumstances under which rescreening can occur (e.g., laboratory value range) and cross reference Section 5.4 if appropriate:<Start of suggested text>［既往歴／合併症、理学的診察?検査、臨床検査、及び心機能の観察］を含む医学的評価により明らかに健康と判定された被験者。OR2.［基準を入力する］である被験者。For studies in patients, provide diseaserelated considerations: standard, accepted diagnostic criteria (consider supplying laboratory reference ranges or clinical diagnostic criteria in an appendix). Include duration/severity of disease or disorder if appropriate.When appropriate, specify a realistic and pragmatic inclusion range for each test or marker of interest. Take into consideration any known assay variance or error rate as well as biological variation to avoid creating protocol violation issues.State whether rescreening will be allowed and the circumstances under which rescreening can occur (e.g., laboratory value range) and cross reference Section 6.4, if appropriate.Check whether additional information associated with the disease area can be found in the therapeutic area libraries.<End of suggested text>体重Consider whether any restriction on weight or BMI is needed for this study intervention/stage of development and delete if not required. <Start of suggested text>体重が［X～X］?kg以内かつBody Mass Index（BMI）が［X］?kg/m2以上［X］?kg/m2以下。<End of suggested text>性別［男性及び／又は女性］<Start of common text>If there are no contraceptive requirements in the study, remove the statement “Contraceptive use by men or women …”. 男性被験者及び女性被験者が用いる避妊方法は、臨床試験参加者の避妊方法に関する各国の規制要件に合致していなければならない。男性被験者See participant libraries for common text to include here女性被験者See participant libraries for common text to include here<End of common text>同意取得<Start of common text>ICF及び本治験実施計画書に記載されている要件及び制限の遵守を含め、別添1で記載されているとおりICFに署名できる。<End of common text>除外基準Exclusion Criteria: See therapeutic area libraries for suggested text. Numbering will start again for exclusion criteria or be continued from the inclusion criteria dependent on company practice or requirements of technology solutions.以下のいずれかの基準に該当する場合は、治験の組入れ対象から除外する。医学的状態[ ]前治療／併用療法[ ]過去／現在の臨床試験への参加経験[ ]診断による評価[ ]その他の除外基準[ ]生活習慣に関する考慮事項[ ][ ]If this section is not applicable, include a statement that no restrictions are required. Do not omit section.Describe any restrictions during any of the study periods pertaining to lifestyle and/or diet. For example, include a statement about exposure to sunlight for study interventions with photosensitivity potential.食事及び食事制限Food and drink restrictions before the start of pharmacokinetic (PK) sample collections.Timing of meals relative to dosing.Ensure consistency in this section with other parts of the protocol and cross reference other sections (e.g., exclusion criteria) as needed.If the exact timing of meals is listed in the SoA, do not repeat this information here. Instead, include a reference to the SoA.<Start of suggested text>治験薬投与開始［X日］前から最終投与後まで、赤ワイン、セビリアオレンジ、グレープフルーツ又はグレープフルーツジュース、［ザボン、外国産の柑橘系果物、グレープフルーツの交配種又はフルーツジュース］の摂取を控える。For food effect studies, water restrictions may be needed. 投与後2時間までの水分摂取は許容されない。それ以降は自由に摂取してよい。<End of suggested text>カフェイン、アルコール及びタバコ製品Restrictions are dependent on the known metabolism of the study intervention in order to eliminate any potential for PK interactions and possible effects of caffeine- and xanthine-containing products on ECG results or other pharmacodynamic endpoints (e.g., blood pressure).The possible effects of alcohol on PK, pharmacodynamic interactions, or laboratory parameters, such as liver function tests, should also be addressed by restrictions in this section.<Start of suggested text>各投与期間中は、投与開始の［X時間］前から薬物動態（PK）及び／又は薬力学的検体の最終採取までカフェイン又はキサンチンを含有する製品（例：コーヒー、お茶、コーラ、チョコレート）の摂取を控える。各投与期間中は、投与開始の24時間前からPK及び／又は薬力学的検体の最終採取までアルコールの摂取を控える。タバコ製品を使用する被験者には、入院中はニコチンを含有する製品（ニコチンパッチを含む）を使用しないよう指示する。［又は］［スクリーニング時／投与開始時］から最終の後観察終了までタバコ製品の使用を禁止する。<End of suggested text>活動Study-specific restrictions may apply depending on the nature and frequency of assessments (eg, in first in human studies, activity may be further restricted by ensuring participants remain in bed for 4 to 6?hours after dosing).<Start of suggested text>被験者は臨床検査の各採血の［X時間］前から激しい運動を控える。治験中は軽い娯楽的活動を行ってもよい（例：テレビ観賞、読書）。<End of suggested text>スクリーニング脱落<Start of common text>スクリーニング脱落例とは、治験への参加に同意したがその後［本治験にランダム化／組入れ］されなかった被験者と定義する。Consolidated Standards of Reporting Trials(CONSORT)の公表に関する要件を満たし、かつ規制当局からの問い合わせに対応するため、スクリーニング脱落例に関して透明性のある報告ができるよう最低限の情報を収集する。最低限の情報には、人口統計学的特性、スクリーニング脱落の詳細、適格性基準及び重篤な有害事象に関する情報を含む。<End of common text>State whether rescreening is permitted. If rescreening is permitted, state the entry criteria/parameters which can be reassessed for individuals who previously failed screening and the time period for repeating procedures/rescreening. Individual inclusion/exclusion criteria may also state whether a repeat procedure is allowed without being considered a rescreen.<Start of suggested text>本治験の参加基準に適合しない被験者（スクリーニング脱落）を、再スクリーニング［可／不可］とする。［再スクリーニングされた被験者には、初回スクリーニングと同じ被験者識別番号を割り当てる。］<End of suggested text>治験薬「治験薬（Study Intervention)」は治験実施計画書に従い、治験薬、治験介入、医療機器等適切な言葉に置き換えてよい。<Start of common text>治験薬とは、本治験実施計画書に従い、被験者に投与するためのあらゆる被験薬、市販製品、プラセボ、又は医療機器と定義される。<End of common text>治験薬の投与「投与（administered)」は治験実施計画書に従い、治験介入の実施、治験薬の投与、医療機器の使用等適切な言葉に置き換えてよい。It is preferred that interventions are described in a table and that text be minimized.The precise interventions or diagnostic agents to be administered in each arm of the study and for each period of the study should be described including route and mode of administration, dose, and dosage regimen and duration of intervention.For devices, include details on the set-up and use of the device (see Section 6.1.1 Medical Devices). A Device User Manual can be included as an Appendix.The example table should be modified as needed. Instructions for table are as follows: Arm Name: Please Enter 1 arm name per row Intervention Name: Please enter a generic (INN) or trade name if required as per CMC, if applicable, or MK/V numberType: Select one option from this list: Drug: Including placeboDevice: Including shamBiological/VaccineProcedure/SurgeryRadiationBehavioral: For example, psychotherapy, lifestyle counselingGenetic: Including gene transfer, stem cell and recombinant DNADietary Supplement: For example, vitamins, mineralsCombination Product: Combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and deviceDiagnostic Test: For example, imaging, in-vitroOtherDose Formulation: For device protocols, include Device configuration / Style / ModelsUse: Please select one of the following: experimental, placebo- active-comparator, sham comparator, rescue medication, background intervention, challenge agent, diagnostic, or otherDefinition Investigational Medicinal Product (IMP) and Non- Investigational Medicinal Product (NIMP) is based on guidance issued by the European Commission. Regional and/or Country differences of the definition of IMP/NIMP may exist. In these circumstances, local legislation is followed.If applicable add current and former name(s) or alias(es) if any, different from the intervention name(s) that the sponsor has used publicly to identify the intervention(s), including, but not limited to, past or present names such as brand name(s) or serial number(s).投与群［X］［Y］［Z］治験薬名［CMCによる一般名（必要な場合は商品名）、該当する場合、治験依頼者番号］［プラセボ］[レスキュー薬又は負荷物質等その他の追加製剤]種類［薬剤／医療機器／生物製剤］［薬剤／医療機器／生物製剤］［薬剤／医療機器／生物製剤］剤形［錠剤／アンプル／カプセル］［錠剤／アンプル／カプセル］［錠剤／アンプル／カプセル］力価［上記の被験薬、プラセボ、実薬対照薬等の力価］［上記の被験薬、プラセボ、実薬対照薬等の力価］［上記の被験薬、プラセボ、実薬対照薬等の力価］用法?用量［投与量及び投与頻度］［投与量及び投与頻度］［投与量及び投与頻度］投与経路［経口／筋肉内投与／点滴静注／静脈内投与］［経口／筋肉内投与／点滴静注／静脈内投与］［経口／筋肉内投与／点滴静注／静脈内投与］使用目的［被験薬、プラセボ又は実薬対照薬、偽対照薬、レスキュー薬、基礎治療、負荷物質、診断薬、又はその他］［被験薬、プラセボ又は実薬対照薬、偽対照薬、レスキュー薬、基礎治療、負荷物質、診断薬、又はその他］［被験薬、プラセボ又は実薬対照薬、偽対照薬、レスキュー薬、基礎治療、負荷物質、診断薬、又はその他］治験薬及び非治験薬治験薬及び非治験薬治験薬及び非治験薬治験薬及び非治験薬供給元［必要に応じて記載／変更する：治験依頼者により一括供給される、又は各国の実施医療機関、子会社又は委託機関により調達される。医療機器の場合、製造業者を記載する。］［必要に応じて記載／変更する：治験依頼者により一括供給される、又は各国の実施医療機関、子会社又は委託機関により調達される。医療機器の場合、製造業者を記載する。］［必要に応じて記載／変更する：治験依頼者により一括供給される、又は各国の実施医療機関、子会社又は委託機関により調達される。医療機器の場合、製造業者を記載する。］包装及びラベル治験薬は［容器］で提供される。各国の要件に従い、各［容器］には必要に応じてラベル表示する。治験薬は［容器］で提供される。各国の要件に従い、各［容器］には必要に応じてラベル表示する。治験薬は［容器］で提供される。各国の要件に従い、各［容器］には必要に応じてラベル表示する。［現在／過去の名称又は別称］現在の名称又は別称現在の名称又は別称現在の名称又は別称医療機器This section is required for medical devices and can be deleted for non-device protocols. A Device User Manual can be included as an appendix to the protocol.Describe any sponsor provided medical device including any materials that will be in contact with tissues or body fluids. Include details of any medicinal products, human or animal tissues or their derivatives, or other biologically active substances.Consult with Regulatory Affairs within sponsor if use of a device is required for the study as not all devices are defined as medical devices and different regions have different definitions of a medical device.Examples of sponsor medical devices include, but are not limited to, the following: metered dose inhaler, autoinjector, inhalation spacers, measuring cups, measuring spoons, pediatric oral syringes, and drypowder inhalers.For devices, if a control product is used, ensure that description of its use is consistent with the applicable DFU in countries where the study will be conducted.Specifically note whether the device is FDA cleared or not. If any diagnostic tests have not been approved or cleared for the indications the protocol is designed to investigate, a detailed test protocol (including specimen collection/storage/processing/testing procedures, result interpretation guide, the number and name(s) of US and non-US testing sites) and a summary/report of test validation studies should accompany the protocol submission.The detection and documentation procedures described in this protocol apply to all sponsor medical devices provided for use in the study.<Start of suggested text>本治験で使用するために提供される［治験依頼者］が製造した医療機器、又は［治験依頼者］のために第三者が製造した医療機器（これらを「治験依頼者の医療機器」と呼ぶ）は［ここに列挙する］。本治験で使用するために提供されるその他の医療機器（［治験依頼者］が製造したものではない医療機器又は［治験依頼者］のために第三者が製造したものではない医療機器）は［ここに列挙する］。医療機器の使用に関する説明を［相互参照できるよう該当情報の記載箇所を示す］に記載する。治験責任（分担）医師は、治験期間を通じてすべての医療機器の不具合（医療機器の故障、使用過誤、ラベルの不適切な表示を含む）を記録及び報告し（8.3.9項を参照）、治験依頼者はこれらを適切に管理しなければならない。<End of suggested text>調製／取扱い／保管／管理Instructions for the preparation of study interventions, including assembly of devices, should be provided (e.g., reconstitution, mixing). If the instructions are lengthy or complicated, it is acceptable to reference the label (if applicable) or include them as an appendix to the protocol or as a separate document(s) provided to the site (e.g., pharmacy manual). If provided to the site as a separate document(s), this should be noted in this section.For device protocols:List key study materials other than the study intervention that will be necessary at the site. Any critical special handling or special procedures should be described. Include specific settings or other details needed for administration or deployment: If applicable, provide a description of the product usage for each participant and list equipment requirements for investigators. Include any participant preparation or anesthesia requirements. Provide a description of any specific medical or surgical procedures involved in the use of the investigational device with reference to the IDFU for device protocols for more detailed instructions.<Start of common text>治験責任（分担）医師又は指名された者は、受領したすべての治験薬について、輸送中に適切な温度条件が維持されたこと、不具合?不整合があった場合は治験薬の使用前までに報告及び解決されていることを確認しなければならない。治験薬は、治験に組み入れられた被験者のみが投与を受け、許可された実施医療機関の職員のみが治験薬を交付又は投与する。すべての治験薬は、ラベルに記載されている保管条件に従って、安全かつ管理された環境下、及び（手動又は自動で）監視されている場所で保管する。治験薬の取扱い及び管理は、治験責任（分担）医師及び許可された実施医療機関の職員以外は行わない。治験責任（分担）医師、実施医療機関、又は実施医療機関の長（該当する場合）は、治験薬の管理、整合性確認及び記録管理（入庫、整合性確認及び最終的な廃棄記録）に関する責任を有する。未使用の治験薬の最終的な廃棄に関する詳細は［治験手順マニュアル又は別途指定する文書］に記載する。<End of common text>バイアス最小化策：ランダム化及び盲検化Describe method of assigning participants to study intervention. If participants will be assigned to intervention sequences as in a cross-over study, then describe these sequences. For complex designs, use of a table is recommended. Briefly describe the randomization procedures (e.g., central randomization procedures), the method used to generate the randomization schedule (e.g., computer generated), the source of the randomization schedule (e.g., sponsor, investigator, or other), and whether or not an Interactive Voice/Web Response System (IVRS/IWRS) will be used. To maintain the integrity of the blind, do NOT include the block size. If adaptive randomization to intervention t is to be used or if other methods of covariate balancing/minimization are employed, provide a cross link to the methods of analysis in Section?9.State any other study-specific rules (e.g., once a randomization number has been assigned it must not be re-assigned).Include details of how and when a participant is allocated a participant number and the participant numbering convention, if relevant, in the Study Reference Manual.Discuss any bias-reducing procedures if randomization is not used.Include the stratification process and stratification variables, if applicable.Example text:Study using IVRS/IWRSAll participants will be centrally assigned to randomized study intervention using an Interactive Voice/Web Response System (IVRS/IWRS). Before the study is initiated, the telephone number and call-in directions for the IVRS and/or the log in information & directions for the IWRS will be provided to each site.Study intervention will be dispensed at the study visits summarized in SoA. Returned study intervention should not be re-dispensed to the participants.Study using PreCoded Randomization provided to siteOn Day [X] participants will be assigned a unique number (randomization number) in ascending numerical order at each study site. The randomization number encodes the participant’s assignment to one of the [X] arms of the study, according to the randomization schedule generated prior to the study by the Statistics Department at [sponsor/designee]. Each participant will be dispensed blinded study intervention, labeled with his/her unique randomization number, throughout the study.End of example text“Masking” or another appropriate synonym may be used in place of “blinding” if considered more appropriate in the context of the study or study population (for example, studies involving visually-impaired participants), but maintain consistent usage within the protocol.Single-blind refers to studies in which participants are blinded to study intervention, but site personnel (for example, monitors and investigators) and sponsor personnel are not. Double-blind refers to studies in which both participants and site personnel are blinded to study intervention.If someone involved in conducting the study is not blinded (for example, the site pharmacist or the sponsor’s clinical trial material group), describe the means used to preserve the blinding of the other personnel conducting the study.Provide a description of the specific blinding procedures, if any, to be used. If blinding will not be used, include a statement to that effect.Describe how any blinding will be achieved and any impact on bias/randomization.Include the circumstances in which the blind will be broken for an individual or for all participants (e.g., for SAE), the procedures to be used to do this, and who has access to participant codes. If the study allows for some investigators to remain unblinded (e.g., to allow them to adjust medication), the means of shielding other investigators should be explained.Example text:Open-label, No blinding at site levelThis is an open-label study; potential bias will be reduced by the following steps: [central randomization, adjudications].Open-label using central randomization via (IVRS/IWRS)This is an open-label study; however, the specific intervention to be taken by a participant will be assigned using an IVRS/IWRS. The site will contact the IVRS/IWRS prior to the start of study intervention administration for each participant. The site will record the intervention assignment on the applicable case report form, if required. Potential bias will be reduced by the following steps: [central randomization, adjudications].Blind Break (IVRS/IWRS)The IVRS/IWRS will be programmed with blind-breaking instructions. In case of an emergency, the investigator has the sole responsibility for determining if unblinding of a participants’s intervention assignment is warranted. Participant safety must always be the first consideration in making such a determination. If the investigator decides that unblinding is warranted, the investigator should make every effort to contact the sponsor prior to unblinding a participant’s intervention assignment unless this could delay emergency treatment of the participant. If a participant’s intervention assignment is unblinded, the sponsor must be notified within 24 hours after breaking the blind. The date and reason that the blind was broken must be recorded in the source documentation and case report form, as applicable.Open-label using blinded randomizationThis is an open-label study; however, the specific intervention to be taken by a participant will be assigned using randomization envelopes. The site will receive blinded randomization envelopes that will be opened in ascending numerical order immediately prior to the start of study intervention administration for each participant. The site will record the date and time the envelope was opened.Note: This is not an approach to be supported from a statistical perspective. Open-label randomized trials need to use central randomization. If envelopes are pre-assigned to the site, the randomization must be blocked at the site level, which introduces selection bias risk whether or not the randomization codes are “blinded” in envelopes.Blind Break (Envelopes)A sealed envelope that contains the study intervention assignment for each participant will be provided to the investigator. The sealed envelope will be retained by the investigator (or representative) in a secured area. In case of an emergency, the investigator has the sole responsibility for determining if unblinding of a participants’s intervention assignment is warranted. Participant safety must always be the first consideration in making such a determination. If the investigator decides that unblinding is warranted, the investigator should make every effort to contact the sponsor prior to unblinding a participant’s intervention assignment unless this could delay emergency treatment of the participant. If a participant’s intervention assignment is unblinded, the sponsor must be notified within 24 hours after breaking the blind. Once the study is complete, all envelopes (sealed and opened) must be inventoried and returned to the sponsor.Blinded study with unblinded site pharmacist who is dispensing drugParticipants will be randomly assigned in a [1:1] ratio to receive study intervention. Investigators will remain blinded to each participant’s assigned study intervention throughout the course of the study. In order to maintain this blind, an otherwise uninvolved 3rd party will be responsible for the reconstitution and dispensation of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense following randomization.This 3rd party will instruct the [participant/participant’s parent(s) or legally authorized representative] to avoid discussing the taste, dosing frequency, or packaging of the study intervention with the investigator.In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study intervention records at the site(s) to verify that randomization/dispensing has been done accurately.End of example text服薬／投薬遵守The measures that will be taken to ensure and document intervention compliance should be described (e.g.,?drug accountability records, diary cards, drug concentration measurements, or medication event monitoring). May include the use of electronic data capture.Consider any implications of under/over dosing and cross reference Section 8.4 if required.Teams should choose the appropriate wording from the options below and delete the wording not used. For devices, participant compliance will depend on the device so describe appropriately.<Start of suggested text for studies using bulk supplies>供給されたバルクから被験者ごとに個別の用量が調製される場合、実施医療機関の別の治験担当者が治験薬の用量を確認する。<End of suggested text for studies using bulk supplies><Start of suggested text when participants dosed at site>実施医療機関で治験薬投与が行われる場合、治験責任（分担）医師の元で、又は指名された者が行う場合には医師の指示に従って、被験者は治験薬の投与を受ける。実施医療機関における各々の投与日時は原資料及び症例報告書（CRF）に記録する。治験薬の投与量と治験薬を投与される被験者の識別については、治験薬投与者に加えて、実施医療機関の別の治験担当者も投薬時に確認する。［実施医療機関の治験担当者は被験者の口腔を調べて治験薬が服用されたことを確認する。］<End of suggested text when participants dosed at site><Start of suggested text for study intervention(s) administered at home>被験者が自宅で治験薬を自ら投与する場合、投与遵守状況は各来院時に確認する。遵守状況を［被験者に直接質問することで、回収した錠剤／カプセルを数えることで、等］来院時に評価し、原資料及びCRFに記録する。指定された用法?用量からの逸脱はCRFに記録する。各被験者に処方され、投与された［治験薬名］の数量の記録を管理し、治験薬及び治験薬管理表と一致していなければならない。治験薬の投与が遅れた日及び／又は減量した日も含めて、投与開始日、投与終了日をCRFに記録する。<End of suggested text for study intervention(s) administered at home>併用療法Describe which interventions or procedures will be allowed before and during the study and any other specific rules and procedures related to permitted or prohibited concomitant therapy. Note that this section also includes surgical procedures for device protocols.Minimize use of concomitant therapies or other co-interventions that can affect critical outcome measures so as to reduce potential imbalances in such co-interventions across interventions groups.Outline expectations for recording the use of concomitant therapies.Mention any non-study interventions, such as background therapy or rescue medication, as applicable.Include sponsor guidance, if any, on the management of study-specific conditions (e.g.,?hyperkalemia, blood pressure control, edema, glucose control) that may need to be treated during the study. Review therapeutic area libraries for additional guidance.Consider whether rescue therapy will be allowed and provide details if appropriate.Cross reference Appendix X - “Excluded Medications” as applicable.Cross reference Appendix X - Medical Device Manual as applicable.<Start of suggested text>被験者が治験組入れ時に使用している、又は治験中に使用するすべての［薬剤やワクチン（一般用医薬品又は処方薬、ビタミン類、及び／又はハーブ系サプリメント、その他の注目すべき特定の種類）］を、以下とともに記録しなければならない。使用理由投与開始日及び終了日を含む投与の日付用量及び投与頻度を含む投与方法に関する情報併用療法又は前治療に関して質問がある場合、メディカルモニターに連絡する。For healthy volunteer studies, consider using the common text beginning 'Participants must abstain from taking prescription...'当該薬剤が治験の評価に影響を与えないと治験責任（分担）医師及び治験依頼者が判断しない限り、治験薬投与開始の7日前（もしくは酵素誘導の可能性のある薬剤の場合は14日前）、又は当該薬剤の半減期の5倍のいずれか長い方の期間前から、後観察来院完了まで、被験者は処方薬又は処方薬以外の医薬品（ビタミン類及び栄養補助食品又はハーブ系サプリメントを含む）の使用を控えなければならない。［アセトアミノフェン］は、用量が［2?g／日以下］であれば、［治験中いつでも／スクリーニング期間中のみ、等］使用可能である。他の併用療法については、［必要であれば］メディカルモニター［と相談の上、治験責任（分担）医師］が個別に検討する。<End of suggested text>レスキュー薬If rescue therapy is permitted, consider using the text appearing in Section 6.5.1.The efficacy section should also address when endpoints (e.g. pain scores) are to be assessed with respect to dosing of rescue medication if relevant.<Start of suggested text>実施医療機関は、［［治験依頼者が提供／実施医療機関が準備］する［種類を特定］レスキュー薬を被験者に交付する。］OR［［種類を特定］レスキュー薬を被験者に交付しない。］以下のレスキュー薬は使用することができる。1.［X］2.［X］レスキュー薬は［治験中いつでも］使用できるが、可能であれば治験薬投与後少なくとも［時間／期間を挿入］使用を控える。レスキュー薬の薬剤名、投与日時、及び用法?用量を記録しなければならない。<End of suggested text>用量変更Procedures to be used for selecting/modifying each participant's dose of study intervention should be described. Cross reference Section 4.3 Justification for Dose as needed and do not repeat information already provided in that section. These procedures can vary from simple random assignment to a selected fixed drug/dosage regimen to the use of a specified titration procedure or more elaborate response/toxicity-determined dose modification procedures (e.g., dose is titrated upward at intervals until intolerance or some specified endpoint is achieved).Do not include information on stopping study intervention for individual participants due to safety/other reasons as this is detailed in Section 7 Discontinuation of Study Intervention and Participant Withdrawal.If dose selection/modification decisions are dependent upon review by a committee, include details in Appendix 3 and make a cross reference here.Consider providing information in tabular format for simplicity.Example text that can be used with study designs that incorporate dose adjustment decisions:This protocol allows some alteration from the currently outlined dosing schedule, but the [maximum daily dose and/or (predicted) maximum/cumulative exposure] will not exceed [X].ORThe decision to proceed to the next dose level of [X] (either an increase or a decrease) will be made by the Study Team [and the investigator] based on safety, tolerability, and preliminary [PK and/or pharmacodynamic] data obtained in at least [X] participants at the prior dose level.ORThe dosing schedule may also be adjusted to expand a dosing cohort to further evaluate [safety, PK and/or pharmacodynamic] findings at a given dose level or to add cohorts to evaluate [up to X] additional dose levels. The study procedures for these additional participant(s)/cohort(s) will be the same as that described for other study participants/cohorts.OR ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download