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The addendum provides the current Step 4 version, including adoption history dated 9 November 2016 and specified integrations into sections of the parental guideline such as Introduction, defined subsections, and multiple numbered guidance areas. It also includes the copyright legal notice describing permitted use, required acknowledgment, labeling of changes, third-party content restrictions, and the document’s “as is” warranty and liability limitations.",{"@graph":69,"@context":126},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/ich-e6r2-integrated-addendum-to-ich-e6r1-guideline-for-good-clinical-practice/373207/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/ich-e6r2-integrated-addendum-to-ich-e6r1-guideline-for-good-clinical-practice/373207.png","ImageObject",300,407,{"name":92,"@type":93},"Kurz","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-24","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118,122],{"name":109,"@type":110,"acceptedAnswer":111},"What does ICH E6(R2) cover in relation to ICH E6(R1)?","Question",{"text":112,"@type":113},"ICH E6(R2) provides an integrated addendum to the ICH E6(R1) Guideline for Good Clinical Practice, with changes integrated into specified sections of the parental guideline.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"When was the current ICH E6(R2) addendum Step 4 version adopted?",{"text":117,"@type":113},"The current E6(R2) Addendum Step 4 version is associated with adoption dated 9 November 2016.",{"name":119,"@type":110,"acceptedAnswer":120},"What legal permissions and obligations are stated for using the document?",{"text":121,"@type":113},"The document may be used, reproduced, incorporated, adapted, modified, translated, or distributed under a public license if ICH copyright is acknowledged at all times, and adaptations/modifications/translations must be clearly labeled or demarcated.",{"name":123,"@type":110,"acceptedAnswer":124},"Does the document provide warranties or limit liability?",{"text":125,"@type":113},"No. The document is provided “as is” without warranty, and ICH and the original authors are not liable for claims, damages, or other liabilities arising from use.","https://schema.org",{"og:url":83,"og:type":128,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":130,"canonical":83},"index,follow",{"doc_id":132,"site_id":62},373207,1790217976,{"code":4,"msg":5,"data":135},{"doc_id":132,"user_id":136,"nickname":92,"user_avatar":137,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":138,"file_id":139,"file_url":140,"file_type":141,"file_size":142,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":143,"language":144,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":145,"faqs":146,"seo_title":147,"seo_description":67,"update_tm":148,"read_time":149},2336478945635,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)  \nICH HARMONISED GUIDELINE  \nINTEGRATED ADDENDUM TO ICHE6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE  \nE6(R2)  \nCurrent Step 4 version  \ndated 9 November 2016  \nE6(R1) Document History  \n\n| First\u003Cbr>Codification | History | Date | New\u003Cbr>Codification\u003Cbr>November\u003Cbr>2005 |\n| --- | --- | --- | --- |\n| E6 | Approval by the Steering Committee under Step 2 and release for public consultation. | 27\u003Cbr>April\u003Cbr>1995 | E6 |\n| E6 | Approval by the Steering Committee under Step 4 and recommended for adoption to the three ICH regulatory bodies. | 1\u003Cbr>May\u003Cbr>1996 | E6 |\n\nE6(R1) Step 4 version  \n\n| E6 | Approval by the Steering Committee of Post-Step 4 editorial corrections. | 10\u003Cbr>June\u003Cbr>1996 | E6(R1) |\n| --- | --- | --- | --- |\n\nCurrent E6(R2) Addendum Step 4 version  \n\n| Code | History | Date |\n| --- | --- | --- |\n| E6(R2) | Adoption by the Regulatory Members of the ICH Assembly under Step 4.\u003Cbr>Integrated Addendum to ICH E6(R1) document. Changes are integrated directly into the following sections of the parental Guideline: Introduction, 1.63,  1.64,  1.65, 2.10, 2.13, 4.2.5, 4.2.6, 4.9.0, 5.0, 5.0. 1, 5.0.2, 5.0.3, 5.0.4, 5.0.5, 5.0.6 , 5.0.7, 5.2.2, 5.5.3 (a), 5.5.3 (b), 5.5.3 (h), 5.18.3, 5.18.6 (e), 5.18.7, 5.20.1, 8.1 | 9 November\u003Cbr>2016 |\n\nLegal notice: This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided.  \nThe document is provided \"as is\" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document.  \nThe above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.  \nICH HARMONISED GUIDELINE  \nINTEGRATED ADDENDUM TOICHE6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH  \nE6(R2)  \nICH Consensus Guideline  \nTABLE OF CONTENTS  \nINTRODUCTION.......................................................................................................... 1  \n1. GLOSSARY ......................................................................................................... 2  \n2. THE PRINCIPLES OF ICH GCP .......................................................................... 9  \n3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) .......................................................................................................... 10  \n3.1 Responsibilities ........................................................................................................ 10  \n3.2 Composition, Functions and Operations ...................................................................... 11  \n3.3 Procedures............................................................................................................... 11  \n3.4 Records ................................................................................................................... 12  \n4. INVESTIGATOR ............................................................................................... 13  \n4.1 Investigator's Qualifications and Agreements............................................................... 13  \n4.2 Adequate Resources ................................................................................................. 13  \n4.3 Medica","cbCaijWNjO5F6wGJ","https://ap.wps.com/l/cbCaijWNjO5F6wGJ","pdf",665633,66,"English","# INTRODUCTION\n# 1. GLOSSARY\n# 2. THE PRINCIPLES OF ICH GCP\n# 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)\n## 3.1 Responsibilities\n## 3.2 Composition, Functions and Operations\n## 3.3 Procedures\n## 3.4 Records\n# 4. INVESTIGATOR\n## 4.1 Investigator's Qualifications and Agreements\n## 4.2 Adequate Resources\n## 4.3 Medical Care of Trial Subjects\n## 4.4 Communication with IRB/IEC\n## 4.5 Compliance with Protocol\n## 4.6 Investigational Product(s)\n## 4.7 Randomization Procedures and Unblinding\n## 4.8 Informed Consent of Trial Subjects\n## 4.9 Records and Reports\n## 4.10 Progress Reports\n## 4.11 Safety Reporting\n## 4.12 Premature Termination or Suspension of a Trial\n## 4.13 Final Report(s) by Investigator\n# 5. SPONSOR\n## 5.0 Quality Management\n## 5.1 Quality Assurance and Quality Control\n## 5.2 Contract Research Organization (CRO)\n## 5.3 Medical Expertise\n## 5.4 Trial Design","[{\"question\":\"What does ICH E6(R2) cover in relation to ICH E6(R1)?\",\"answer\":\"ICH E6(R2) provides an integrated addendum to the ICH E6(R1) Guideline for Good Clinical Practice, with changes integrated into specified sections of the parental guideline.\"},{\"question\":\"When was the current ICH E6(R2) addendum Step 4 version adopted?\",\"answer\":\"The current E6(R2) Addendum Step 4 version is associated with adoption dated 9 November 2016.\"},{\"question\":\"What legal permissions and obligations are stated for using the document?\",\"answer\":\"The document may be used, reproduced, incorporated, adapted, modified, translated, or distributed under a public license if ICH copyright is acknowledged at all times, and adaptations/modifications/translations must be clearly labeled or demarcated.\"},{\"question\":\"Does the document provide warranties or limit liability?\",\"answer\":\"No. The document is provided “as is” without warranty, and ICH and the original authors are not liable for claims, damages, or other liabilities arising from use.\"}]","ICH E6(R2) - Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice | PDF",1790197919,166]