{"title":"Regulatory Guides","description":"","products":[{"product_id":"cra-training-series-volume-7-test-your-cra-knowledge-2018","title":"CRA Training Series: Volume 7 - Test Your CRA Knowledge (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 7 - Test Your CRA Knowledge\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe seventh volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, Test Your CRA Knowledge is a series of questions and answers designed to test your knowledge of the information presented in the six volumes of The Self-Study CRA Training Series. The questions were developed from the volumes with the assumption that you possess some basic knowledge of clinical research. You are given an opportunity to assess your strengths and weakness by comparing your answers in the first section to the answers presented in the second section. You may use this manual in several ways. Used as a pre-test before reading the other manuals in the series, your performance in answering the questions may indicate areas of strength and weakness in your knowledge of the roles and responsibilities of the Clinical Research Associate (CRA). Based on your score, you may wish to review the volumes on those subject areas in which your performance was less than desired or expected. You may also use this manual as a post-test to verify your retention of the material presented in the six self-study volumes.\u003c\/p\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e\u003cbr\u003e\n\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003eCheck out the other volumes in the series:\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195023192429,"sku":"CRAV718","price":99.0,"currency_code":"USD","in_stock":true},{"title":"Standard","offer_id":52122579435885,"sku":"18961","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover7_364x473_3c13cc82-45d9-4790-8b12-5a5335e50e3d.jpg?v=1758091692"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide-2024-2025","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2024\/2025","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cdiv class=\"leftColumn\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/docs\/librariesprovider43\/default-document-library\/gcp-toc.pdf?sfvrsn=b5f4e482_1\"\u003eView the Table of Contents\u003c\/a\u003e\u003c\/p\u003e\n\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cp\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/images\/librariesprovider43\/publications\/interview-spotlight.jpg?sfvrsn=2919dec1_1\" alt=\"Interview Spotlight\" class=\"imageResize\"\u003e\u003c\/p\u003e\n\u003cp\u003eHear a conversation between \u003cb\u003eEditor-in-Chief, Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C. and Keith Dorricott\u003c\/b\u003e, as they discuss Risk-Based Quality Management and share insights from the Good Clinical Practice: A Question \u0026amp; Answer Reference Guide on this important topic.\u003c\/p\u003e\n\u003c!-- START VideoEmbed --\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-6\" style=\"width: auto; margin: 10px 0;\"\u003e\n\u003cdiv class=\"videoWrapper\"\u003e\u003ciframe width=\"560\" height=\"315\" src=\"https:\/\/www.youtube.com\/embed\/H540fRQ8ers?rel=0\" title=\"YouTube video player\"\u003e\u003c\/iframe\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!--END  VideoEmbed --\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eListen to an Interview with \u003cb\u003eRob DiCicco, VP Portfolio Management, Transcelerate Biopharma Inc. and Editor-in-Chief, Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.\u003c\/b\u003e, as she discusses what's new in this edition, including new chapters, integrated global content, and our expert editorial team.\u003c\/p\u003e\n\u003c!-- START VideoEmbed --\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-6\" style=\"width: auto; margin: 10px 0;\"\u003e\n\u003cdiv class=\"videoWrapper\"\u003e\u003ciframe width=\"560\" height=\"315\" src=\"https:\/\/www.youtube.com\/embed\/6J-l5DfPRX8?rel=0\" title=\"YouTube video player\"\u003e\u003c\/iframe\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!--END  VideoEmbed --\u003e\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cp class=\"Abstract pad-top\" style=\"text-align: left;\"\u003eIn the past several years we have seen the release of many new regulations and guidances throughout the world. We have come out of a pandemic which has changed how we conduct and manage clinical trials, and we are dealing with an unstable world where research subjects are living in war torn regions. The 2024\/2025 edition of Barnett’s Good Clinical Practice: A Question \u0026amp; Answer Reference Guide has been reorganized with added topics to address this new era of clinical research. Written by more than 20 subject matter experts in core clinical research areas, this industry-leading GCP reference guide answers over 1,500 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials.\u003cspan style=\"font-family: inherit;\"\u003e \u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003cp\u003e\u003cb style=\"background-color: transparent; color: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit;\"\u003eSome highlights of the completely updated and expanded guide include:\u003c\/b\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cdiv class=\"Abstract\" style=\"margin-left: 2em;\"\u003e\n\u003cul\u003e\n\u003cli\u003eAn all-new section on risk-based quality management (RBQM) and Quality by Design, which are receiving ever more emphasis from global regulators\u003c\/li\u003e\n\u003cli\u003eEmphasis on Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs) and approaches to outsourcing RBQM\u003c\/li\u003e\n\u003cli\u003eUpdates specific to ICH E6 and E8 including the ICH E6 (R3) Draft\u003c\/li\u003e\n\u003cli\u003ePublic comments from regulators and references to other industry guidance\/sources\u003c\/li\u003e\n\u003cli\u003eImpact of the new Clinical Trial Regulations in the EU and how Clinical Trial Information System (CTIS) are used for SUSAR reporting in Europe\u003c\/li\u003e\n\u003cli\u003eContent covering Decentralized Clinical Trials (DCTs) and what evidence regulators require for data quality\u003c\/li\u003e\n\u003cli\u003eQuestions and answers regarding the balancing of equity and equality in trials (including study design, patient recruitment, compensation structures)\u003c\/li\u003e\n\u003cli\u003eDetails around the use of real-time data monitoring and participant engagement technologies and their ethical implications\u003c\/li\u003e\n\u003cli\u003eA new section on conducting a clinical trial during a pandemic and\/or war including trial management, risk assessments, monitoring activities, investigational product management, informed consent, and site change considerations\u003c\/li\u003e\n\u003cli\u003eAnd much more…!\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52142471971181,"sku":"GCP24","price":139.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2026_GCP-Q_A_400x514_71102b0e-c777-4119-bce7-411d613b0279.jpg?v=1760111691"},{"product_id":"cra-training-series-volume-6-the-cras-reference-for-adverse-events-2018","title":"CRA Training Series: Volume 6 - The CRA's Reference for Adverse Events (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 6 - The CRA's Reference for Adverse Events\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe sixth volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, The CRA’s Reference for Adverse Events is designed to serve as a practical teaching tool. The Clinical Research Associate (CRA)is responsible for verifying that the investigational site personnel are appropriately identifying, classifying, recording, and reporting adverse events (AEs). By accurately and effectively monitoring the study site's handling of AEs, CRAs ensure that the sponsor and study site members are acting within the bounds of the law, and perhaps more importantly, that study subjects are protected. This volume provides basic information on identifying, collecting, classifying, and reporting AEs. It is a compilation of regulatory information, procedural guidance, and learning exercises designed to provide immediate applicable instruction for dealing with AEs. Specifically, the manual includes the following content:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eTerms and concepts necessary to properly recognize AEs in clinical research\u003c\/li\u003e\n    \u003cli\u003eResponsibilities of study site personnel in observing and managing AEs\u003c\/li\u003e\n    \u003cli\u003eReview of CRFs and source documents for AEs\u003c\/li\u003e\n    \u003cli\u003eExplanation of applicable U.S. and ICH regulations governing AE\u003c\/li\u003e\n    \u003cli\u003eThe classification process of AEs and how to handle those that are reportable\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e\u003cbr\u003e\n\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003eCheck out the other volumes in the series:\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52142472003949,"sku":"CRAV618","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover6_364x473_5e23e29b-2cbd-411c-8cb4-21437be99fa1.jpg?v=1758091486"},{"product_id":"cra-training-series-a-7-volume-cra-self-study-curriculum-2018","title":"CRA Training Series: A 7-Volume CRA Self-Study Curriculum (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003eBarnett Clinical Research Associate (CRA) Training Series (2018): \u003cem\u003eA 7-Volume CRA Self-Study Curriculum\u003c\/em\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis unique self-study curriculum is designed to provide a hands-on perspective surrounding the day-to-day work of the clinical research monitor. Newly updated to include requirements of ICH GCP E6 R2, this 7-volume set provides the fundamentals of being a Clinical Research Associate (CRA) in today’s environment. Each volume can be used as a stand-alone reference or as a complete self-study training series.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe following content is included (by volume):\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 1: An Overview of Drug Development\u003c\/span\u003e\u003c\/strong\u003e is written to introduce new CRAs to the drug development process, while contextualizing it to the role of the CRA. Included are important terms and acronyms encountered by CRAs, as well as what happens before and after a clinical study.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 2: Identifying and Screening Investigators\u003c\/span\u003e\u003c\/strong\u003e focuses on the characteristics of good clinical investigators and the process of finding investigators who meet the needs of the protocol, the formal plan for the study. Included are procedures for investigator identification and screening, first contact and investigator selection.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 3: Conducting Prestudy Visits\u003c\/span\u003e\u003c\/strong\u003e describes the process of preparing for the site visit, conducting the visit, and assessing the site. Included are details regarding meeting agendas and scheduling, budget negotiation techniques, site assessment criteria and necessary discussion points, and recommended procedures and documentation.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 4: Conducting Study Initiation Visits\u003c\/span\u003e\u003c\/strong\u003e covers the training of site staff to conduct the study. Included are guidelines for planning, conducting and documenting a study initiation visit, including the objectives, preparation, task analysis and documentation and follow-up.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/span\u003e\u003c\/strong\u003e describes how to prepare for, conduct, and follow up monitoring visits from the time that the first subject is enrolled to the final site visit. Included are strategies for ensuring that the study is being conducted according to the protocol and good clinical practice (GCP).\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/span\u003e\u003c\/strong\u003e serves as a reference for the AE-reporting process and provides procedures for the monitor to follow.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eVolume 7: Test Your CRA Knowledge\u003c\/span\u003e\u003c\/strong\u003e is filled with exercises which test your knowledge and understanding of the material presented in the previous volumes. Answers for each of the questions are included in the second section of the manual, making immediate feedback available.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599. To order Barnett’s Clinical Research Associate Training Series call: 1-800-856-2556 or email: \u003ca href=\"mailto:customer.service@barnettinternational.com?subject=CRA%20Training%20Series\" title=\"CRA Training Series\"\u003ecustomer.service@barnettinternational.com\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cbr\u003e\n\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCheck out the other volumes in the series:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144022094189,"sku":"CRAS18","price":599.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover1_364x473_a2985ccd-7da4-49f4-ac64-0df41e2ff789.jpg?v=1758091230"},{"product_id":"the-clinical-research-finance-roadmap-a-comprehensive-guide-to-the-financial-aspects-of-clinical-research","title":"The Clinical Research Finance Roadmap: A Comprehensive Guide to the Financial Aspects of Clinical Research","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eIn the age of technology, many organizations struggle with incorporating federal and billing regulations with electronic systems. This comprehensive guide takes the reader through the clinical research financial road map in a step-by-step fashion. It focuses on the financial feasibility of considering a clinical research study, incorporating the study into integrated systems, and managing patient and sponsor billing. \u003cstrong\u003eThe Clinical Research Finance Roadmap: A Comprehensive Guide to the Financial Aspects of Clinical Research\u003c\/strong\u003e provides an in-depth look at the applicable regulations, operational efficiencies and risk mitigation strategies through the implementation of a compliant Clinical Research Billing (CRB) program. Readers will learn how to leverage study and patient data to maintain and enhance a comprehensive and compliant CRB program. \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eChapter 1: History of Clinical Research and Protecting Human Subjects\u003c\/li\u003e\n    \u003cli\u003eChapter 2: The Feasibility Assessment Phase: Deciding to Participate in Clinical Research Study With a Focus on Financial Feasibility\u003c\/li\u003e\n    \u003cli\u003eChapter 3: Creating a Medicare Coverage Analysis (MCA): A Step-By-Step Approach; Billing Regulation Review\u003c\/li\u003e\n    \u003cli\u003eChapter 4: Clinical Trial Budgets and the Hidden Costs\u003c\/li\u003e\n    \u003cli\u003eChapter 5: Negotiating a Clinical Trial Budget\u003c\/li\u003e\n    \u003cli\u003eChapter 6: Integrating with the Electronic Health Record – Creating a Billing Grid\u003c\/li\u003e\n    \u003cli\u003eChapter 7: Investigator and Study Team Preparedness – Training and Study Initiation\u003c\/li\u003e\n    \u003cli\u003eChapter 8: Patient Billing: Charge Review Process and Medical Documentation\u003c\/li\u003e\n    \u003cli\u003eChapter 9: Participant Remuneration\u003c\/li\u003e\n    \u003cli\u003eChapter 10: Study Revisions\/Contract and Budget Amendments\u003c\/li\u003e\n    \u003cli\u003eChapter 11: Sponsor Billing: Payment Milestones\u003c\/li\u003e\n    \u003cli\u003eChapter 12: Study Close-Out: Reconciliation Processes and Ensuring All Payments Received\u003c\/li\u003e\n    \u003cli\u003eChapter 13: Leverage Data: Using Patient and Study Data to Manage Current and Future Studies\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eView the companion reference guide for this publication by clicking  \u003ca href=\"\/publications\/the-clinical-research-finance-roadmap-companion-reference-guide-tools-templates-and-resources-(electronic)\" title=\"here\"\u003ehere\u003c\/a\u003e\u003c\/p\u003e\n\u003cdiv\u003e \u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144022716781,"sku":"FIN19","price":169.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2019_ClinicalResearchFinanceRoadmap_364x475_1ed1f549-69d9-4d9d-a507-d84751127376.jpg?v=1758092555"},{"product_id":"the-clinical-research-finance-roadmap-companion-reference-guide-tools-templates-and-resources-electronic","title":"The Clinical Research Finance Roadmap Companion Reference Guide: Tools, Templates and Resources (Electronic)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eThis companion reference guide to The Clinical Research Finance Roadmap: A Comprehensive Guide to the Financial Aspects of Clinical Research provides tools, templates and resources to assist the Principal Investigator and others with navigating through the clinical research finance processes. \u003cstrong\u003eThe Clinical Research Finance Roadmap Companion Reference Guide: Tools, Templates and Resources\u003c\/strong\u003e provides helpful forms and templates. The tools and resources aid with developing a risk-based approach to managing the clinical research portfolio, navigating decision trees for determining financial feasibility, development of Medicare Coverage Analysis (MCA), developing budgets, tracking milestones, managing sponsor payments, and patient remuneration. The guide is provided in electronic format.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSpecific Tools, Templates and Resources Include:\u003c\/strong\u003e  \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eCalendar for the Identification of Procedures and Timepoints\u003c\/li\u003e\n\u003cli\u003eCharge Review Tracking Tool\u003c\/li\u003e\n\u003cli\u003eClinical Research Decision-making Go\/No-Go Decision Making Tool\u003c\/li\u003e\n\u003cli\u003eCreating a Clinical Trial Budget Template\u003c\/li\u003e\n\u003cli\u003eDecision Tree for Reviewing NCD\/LCD for Coverage\u003c\/li\u003e\n\u003cli\u003eFinancial Clearance for Subjects Forms:Insurance Pre-authorizations and Denials\u003c\/li\u003e\n\u003cli\u003eMonitor Visits Tracking Tool for Reconciliation with Contract Terms for Payments\u003c\/li\u003e\n\u003cli\u003eParticipant Remuneration Worksheet\u003c\/li\u003e\n\u003cli\u003eProductivity Models\u003c\/li\u003e\n\u003cli\u003eQualifying Clinical Trial Objectives Tool\u003c\/li\u003e\n\u003cli\u003eStaffing Model Development Tool\u003c\/li\u003e\n\u003cli\u003eStudy Close Out – Reconciliation Process Tool for Ensuring All Payments Received\u003c\/li\u003e\n\u003cli\u003eClinical Trial Activation Metrics Tracking Tool\u003c\/li\u003e\n\u003cli\u003eTemplates for Standardizing Study Notes\u003c\/li\u003e\n\u003cli\u003eTimeline Tool for Missed Patient Appointments and Schedule Adjustments\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eView the companion publication for this reference guide by clicking  \u003ca href=\"\/publications\/the-clinical-research-finance-roadmap-a-comprehensive-guide-to-the-financial-aspects-of-clinical-research\" title=\"here\"\u003ehere\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e \u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144022847853,"sku":"FINCOM19E","price":119.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2019_ClinicalResearchFinanceRoadmap_364x475_24d318b6-0810-4226-b1cc-56e7c039c400.jpg?v=1758092538"},{"product_id":"study-site-training-series-2018-volume-5-your-role-in-reporting-adverse-experiences","title":"Study Site Training Series (2018): Volume 5: Your Role in Reporting Adverse Experiences","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003eThis volume covers how to observe, manage, classify, record and report AEs during clinical studies. It is also intended to familiarize study team members with the many specific procedures required by regulatory agencies to ensure patient safety.\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144022913389,"sku":"SSSV18-5","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover5_364x473_46661752-3d21-47f3-a37b-48ff34fafe41.jpg?v=1758092507"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide-2024-2025-electronic","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2024\/2025 (Electronic)","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cdiv class=\"leftColumn\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/docs\/librariesprovider43\/default-document-library\/gcp-toc.pdf?sfvrsn=b5f4e482_1\"\u003eView the Table of Contents\u003c\/a\u003e\u003c\/p\u003e\n\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cp\u003e\u003cimg class=\"imageResize\" alt=\"Interview Spotlight\" src=\"https:\/\/stage.barnettinternational.com\/images\/librariesprovider43\/publications\/interview-spotlight.jpg?sfvrsn=2919dec1_1\"\u003e\u003c\/p\u003e\n\u003cp\u003eHear a conversation between \u003cb\u003eEditor-in-Chief, Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C. and Keith Dorricott\u003c\/b\u003e, as they discuss Risk-Based Quality Management and share insights from the Good Clinical Practice: A Question \u0026amp; Answer Reference Guide on this important topic.\u003c\/p\u003e\n\u003c!-- START VideoEmbed --\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-6\" style=\"width:auto; margin: 10px 0;\"\u003e\n\u003cdiv class=\"videoWrapper\"\u003e\u003ciframe title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/H540fRQ8ers?rel=0\" height=\"315\" width=\"560\"\u003e\u003c\/iframe\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!--END  VideoEmbed --\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eListen to an Interview with \u003cb\u003eRob DiCicco, VP Portfolio Management, Transcelerate Biopharma Inc. and Editor-in-Chief, Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.\u003c\/b\u003e, as she discusses what's new in this edition, including new chapters, integrated global content, and our expert editorial team.\u003c\/p\u003e\n\u003c!-- START VideoEmbed --\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-6\" style=\"width:auto; margin: 10px 0;\"\u003e\n\u003cdiv class=\"videoWrapper\"\u003e\u003ciframe title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/6J-l5DfPRX8?rel=0\" height=\"315\" width=\"560\"\u003e\u003c\/iframe\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!--END  VideoEmbed --\u003e\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cp style=\"text-align: left;\" class=\"Abstract pad-top\"\u003eIn the past several years we have seen the release of many new regulations and guidances throughout the world. We have come out of a pandemic which has changed how we conduct and manage clinical trials, and we are dealing with an unstable world where research subjects are living in war torn regions. The 2024\/2025 edition of Barnett’s Good Clinical Practice: A Question \u0026amp; Answer Reference Guide has been reorganized with added topics to address this new era of clinical research. Written by more than 20 subject matter experts in core clinical research areas, this industry-leading GCP reference guide answers over 1,500 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials.\u003cspan style=\"font-family: inherit;\"\u003e \u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003cp\u003e\u003cb style=\"background-color: transparent; color: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit;\"\u003eSome highlights of the completely updated and expanded guide include:\u003c\/b\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cdiv style=\"margin-left: 2em;\" class=\"Abstract\"\u003e\n\u003cul\u003e\n\u003cli\u003eAn all-new section on risk-based quality management (RBQM) and Quality by Design, which are receiving ever more emphasis from global regulators\u003c\/li\u003e\n\u003cli\u003eEmphasis on Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs) and approaches to outsourcing RBQM\u003c\/li\u003e\n\u003cli\u003eUpdates specific to ICH E6 and E8 including the ICH E6 (R3) Draft\u003c\/li\u003e\n\u003cli\u003ePublic comments from regulators and references to other industry guidance\/sources\u003c\/li\u003e\n\u003cli\u003eImpact of the new Clinical Trial Regulations in the EU and how Clinical Trial Information System (CTIS) are used for SUSAR reporting in Europe\u003c\/li\u003e\n\u003cli\u003eContent covering Decentralized Clinical Trials (DCTs) and what evidence regulators require for data quality\u003c\/li\u003e\n\u003cli\u003eQuestions and answers regarding the balancing of equity and equality in trials (including study design, patient recruitment, compensation structures)\u003c\/li\u003e\n\u003cli\u003eDetails around the use of real-time data monitoring and participant engagement technologies and their ethical implications\u003c\/li\u003e\n\u003cli\u003eA new section on conducting a clinical trial during a pandemic and\/or war including trial management, risk assessments, monitoring activities, investigational product management, informed consent, and site change considerations\u003c\/li\u003e\n\u003cli\u003eAnd much more…!\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144029663597,"sku":"GCP24E","price":129.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2026_GCP-Q_A_400x514_5928a301-f9e1-4d7b-a3db-6672e587490b.jpg?v=1758091757"},{"product_id":"the-form-fda-1572-a-reference-guide-for-clinical-researchers-sponsors-and-monitors","title":"The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp class=\"Abstract\"\u003e\u003cstrong\u003e\u003c\/strong\u003eThis year alone, well over 20,000 clinical investigators from around the globe will complete the mandatory Form FDA 1572-Statement of Investigator before participating in FDA-regulated clinical trials. And many of them may not truly appreciate the growing complexities involved in completing the mandatory form-and the implications for these researchers and study sponsors if they fail to complete the form appropriately.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThey should. Over the last year, the FDA has issued significantly more warning letters to clinical investigators. More importantly, the failure to complete the 1572 correctly has become an increasingly common citation in the very latest warning letters!\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eToday, the fact that even experienced clinical investigators continue to struggle with long-standing 1572-related questions is further complicated by the growing complexity of modern clinical trials. Multiple \"satellite sites,\" what the FDA calls the \"dispersing of study functions,\" and other emerging factors have made completing this otherwise mundane form a challenge. Add to this the reality that growing numbers of clinical investigators participating in FDA-regulated trials are located outside the United States--approximately 42% of all clinical investigators signing 1572s in 2007-and may not have any experience with the mandatory form.\u003c\/p\u003e\n\u003cp style=\"border:medium none;padding:0in;\"\u003e\u003cem\u003e\"A large percentage of the questions that we receive in the [FDA's Good Clinical Practice Program] pertain to the 1572 and how it should be completed.\"\u003c\/em\u003e\u003cstrong\u003eFDA's Good Clinical Practice Program, August 2008\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eWe've taken our own experiences, in-depth discussions and correspondence with the FDA, and the agency's latest regulations and guidance documents and created a state-of-the-art reference guide for the proper completion of the Statement of Investigator form. In doing so, we've addressed all the most often-asked--but never answered--questions and also explored emerging areas of uncertainty related to the growing complexity of today's clinical trials, including:\u003c\/p\u003e\n\u003cdiv class=\"Abstract\" style=\"margin-top:0in;margin-left:2em;\"\u003e\n\u003cul\u003e\n    \u003cli\u003eWhen must a non-US clinical investigator sign a 1572?\u003c\/li\u003e\n    \u003cli\u003eHow can a clinical investigator determine when a member of the site staff should be identified as a \"subinvestigator\"?\u003c\/li\u003e\n    \u003cli\u003eWhat are the legal\/regulatory implications of signing a 1572-is it a legal contract?\u003c\/li\u003e\n    \u003cli\u003eWhen can a sponsor consider a clinical investigator to meet the \"appropriate expert\" standard?\u003c\/li\u003e\n    \u003cli\u003eWhat do we do now that at least one foreign country has banned the use of the 1572 for it clinical investigators?\u003c\/li\u003e\n    \u003cli\u003eHow should \"co-investigators\" be handled in the 1572?\u003c\/li\u003e\n    \u003cli\u003eMust clinical investigators sign 1572s for \"satellite sites\"?\u003c\/li\u003e\n    \u003cli\u003eWhat must a study sponsor do beyond \"collecting the paper\" in the 1572 process?\u003c\/li\u003e\n\u003c\/ul\u003e\n \u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003eWho Should Read This Guide:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv class=\"Abstract\" style=\"margin-top:0in;margin-left:2em;\"\u003e\n\u003cul\u003e\n    \u003cli\u003eClinical trial monitors\u003c\/li\u003e\n    \u003cli\u003eClinical investigators and site staff\u003c\/li\u003e\n    \u003cli\u003eResearch center compliance managers\u003c\/li\u003e\n    \u003cli\u003eIRB managers\u003c\/li\u003e\n    \u003cli\u003eClinical study auditors\u003c\/li\u003e\n    \u003cli\u003eClinical regulatory affairs staff\u003c\/li\u003e\n\u003c\/ul\u003e\n \u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52170840408429,"sku":"INV08","price":45.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/BookStockImage_fcd154f8-c5e8-41de-842a-ba6ce7671cb0.jpg?v=1758092563"},{"product_id":"study-site-training-series-2018-volume-6-understanding-evaluating-and-implementing-clinical-protocols","title":"Study Site Training Series (2018): Volume 6: Understanding, Evaluating, and Implementing Clinical Protocols","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003eThis volume is designed to assist teams in protocol implementation. Included are the features of protocols, evaluation strategies, implementation assessment, as well as basic protocol design and writing.\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52170846732653,"sku":"SSSV18-6","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover6_364x473_1ed031d6-41c9-4565-8d4a-d171236e1f79.jpg?v=1758092515"},{"product_id":"study-site-training-series-2018-volume-3-irbs-iecs-and-informed-consent-protecting-the-rights-of-human-subjects","title":"Study Site Training Series (2018): Volume 3: IRBs\/IECs and Informed Consent: Protecting the Rights of Human Subjects","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003eThis volume includes what investigative site team members need to know regarding protection of the rights and safety of human subjects. In addition to presenting applicable regulations and practical implications, the roles of the IRB\/IEC and the study sponsor are also discussed.\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52170849911149,"sku":"SSSV18-3","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover3_364x473_2213eb64-65f9-4466-9e0d-7640f9e0764f.jpg?v=1758092483"},{"product_id":"cra-training-series-volume-1-an-overview-of-drug-development-2018","title":"CRA Training Series: Volume 1 - An Overview of Drug Development (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 1 - An Overview of Drug Development\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe first volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, An Overview of Drug Development is written to introduce new CRAs to the drug development process, while contextualizing it to the role of the CRA. Included are important terms and acronyms encountered by CRAs, as well as what happens before and after a clinical study. This highly engaging manual also includes exercises allowing the reader to apply their new knowledge to their real-world work environment.\u003c\/p\u003e\n\u003cp\u003eThis manual is both a stand-alone reference and an introduction to the full series. As a reference, An Overview of Drug Development provides an annotated bibliography as a reference for additional reading and educational materials. Each entry to the bibliography is annotated with critical summaries to help you decide which references to explore.\u003c\/p\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eCheck out the other volumes in the series:\u003c\/p\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52170856300909,"sku":"CRAV118","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover1_364x473_99d1625f-03b4-4f5f-bfbb-b39600bf3c9a.jpg?v=1758013428"},{"product_id":"study-site-training-series-2018-volume-1-the-clinical-study-site-team-roles-and-responsibilities","title":"Study Site Training Series (2018): Volume 1: The Clinical Study Site Team: Roles and Responsibilities","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003eThis volume is designed to provide readers with an understanding of the roles, responsibilities, and associated tasks of clinical research team members at investigative sites.\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52170859479405,"sku":"SSSV18-1","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover1_364x473_b8b74fc0-2fba-4ed4-8a6b-2b760a86a0a5.jpg?v=1758092215"},{"product_id":"study-site-training-series-2018-volume-2-fda-clinical-research-regulations-and-gcps-the-essentials","title":"Study Site Training Series (2018): Volume 2: FDA Clinical Research Regulations and GCPs: The Essentials","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003eThis volume describes the “rules” and “guidelines” developed by regulatory agencies designed to regulate the conduct of clinical research, emphasizing those requirements that most directly impact investigative site teams.\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195018899821,"sku":"SSSV18-2","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover2_364x473_165bba29-bdf9-4932-a11f-709cd8e1ff26.jpg?v=1758092235"},{"product_id":"cra-training-series-volume-3-conducting-the-prestudy-visit-2018","title":"CRA Training Series: Volume 3 - Conducting the Prestudy Visit (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 3 - Conducting the Prestudy Visit\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe third volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, Conducting the Prestudy Visit provides guidance on how to conduct the Prestudy visit. Prestudy visits (PSVs), which are also called Site Selection Visits (SSVs), are conducted at a potential study site to introduce the prospective investigator to the study protocol and to familiarize the staff with regulatory obligations and sponsor procedures. In addition, the visit provides an occasion for you to assess the investigator's interest in and ability to carry out the study. This includes determining whether the potential investigator has the time, facilities, equipment, access to subjects, and staff necessary to conduct the study. Specifically, the manual includes the following content:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eHow to schedule the meeting and how to prepare a meeting agenda \u003c\/li\u003e\n    \u003cli\u003eBudget negotiation techniques \u003c\/li\u003e\n    \u003cli\u003eNecessary discussions with site staff and the investigator — the drug, protocol, access to source    documents, case report forms (CRFs), and regulatory and sponsor obligations \u003c\/li\u003e\n    \u003cli\u003eSite assessment criteria\u003c\/li\u003e\n    \u003cli\u003eSelection recommendation procedures and documentation\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e\u003cbr\u003e\n\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003eCheck out the other volumes in the series:\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195019227501,"sku":"CRAV318","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover3_364x473_80ad186a-5a48-4ff1-a604-ad274e913d21.jpg?v=1758091461"},{"product_id":"cra-training-series-volume-2-identifying-and-screening-investigators-2018","title":"CRA Training Series: Volume 2 - Identifying and Screening Investigators (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 2 - Identifying and Screening Investigators\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe second volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, Identifying and Screening Investigators focuses on the characteristics of good clinical investigators and the process of finding investigators who meet the needs of the protocol, the formal plan for the study. Included are procedures for investigator identification and screening, first contact and investigator selection. This highly engaging manual also includes exercises allowing the reader to apply their new knowledge to their real-world work environment. Specifically, the manual includes the following content:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eBackground on the role of investigators in clinical research\u003c\/li\u003e\n    \u003cli\u003eProcedures for identifying potential study sites and investigators\u003c\/li\u003e\n    \u003cli\u003eProcedures for contacting potential investigators\u003c\/li\u003e\n    \u003cli\u003eElements of a site feasibility evaluation\u003c\/li\u003e\n    \u003cli\u003eCriteria for selecting investigators\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/div\u003e\n\u003cdiv\u003e \u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e \u003c\/div\u003e\n\u003cdiv\u003eCheck out the other volumes in the series:\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195023028589,"sku":"CRAV218","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover2_364x473_2a7b3bdf-862a-4f98-b092-14bf6d068cd4.jpg?v=1758091561"},{"product_id":"cra-training-series-volume-5-conducting-routine-monitoring-visits-2018","title":"CRA Training Series: Volume 5 - Conducting Routine Monitoring Visits (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 5 - Conducting Routine Monitoring Visits\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe fifth volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, focuses on Conducting Routine Monitoring Visits. Clinical Research Associates (CRAs) must act as both detectives and troubleshooters. As a CRA you need a broad range of skills to fulfill your many responsibilities. This volume will assist you in developing the skills to confidently and effectively monitor clinical studies. It details the tasks performed in three types of monitoring visits — the first visit after a subject is enrolled; routine visits throughout the study; and the closeout, or final visit to the site. This manual covers the activities that take place after protocol planning, investigator selection, necessary regulatory submissions, negotiation of the study budget, site evaluation, and site training have been completed. Other volumes in this series cover those specific activities in more depth. Upon completion of the manual, you will be able to:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eList the monitoring objectives of CRAs\u003c\/li\u003e\n    \u003cli\u003eDescribe the sources and types of information needed for effective performance as a CRA\u003c\/li\u003e\n    \u003cli\u003eDescribe in detail the tasks that must be performed during a monitoring visit\u003c\/li\u003e\n    \u003cli\u003eOutline the follow-up steps necessary after each monitoring visit and study closeout\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e\u003cbr\u003e\n\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003eCheck out the other volumes in the series:\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195023159661,"sku":"CRAV518","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover5_364x473_982863f4-f603-4dfa-9997-efa8a1cb2ecb.jpg?v=1758091501"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide-electronic","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2020\/2021 (Electronic)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eThis industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded guide includes:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eContinued updates focused on the impact of changes to ICH GCP E6 R2, enforcement of the revisions and its impact on clinical trial processes and systems, including Quality-by-Design and Risk-Based Quality Management (QM) expectations\u003c\/li\u003e\n    \u003cli\u003eChanges resulting from the implementation of the Common Rule including changes in informed consent requirements, the impact of Annex 13 on investigational product management\u003c\/li\u003e\n    \u003cli\u003eImpact of GDPR on eTMF management and common TMF regulatory findings\u003c\/li\u003e\n    \u003cli\u003eDozens of new Q\u0026amp;As including changes resulting from COVID-19\u003c\/li\u003e\n    \u003cli\u003eNew questions focused specifically on how Risk-based Quality Management (Section 5 of the Addendum) impacts monitoring activities\u003c\/li\u003e\n    \u003cli\u003eUpdates on the EU’s General Data Protection Regulation (GDPR) regulation and the MHRA 2018 Data Integrity Guidance\u003c\/li\u003e\n    \u003cli\u003eCoverage on updates to the “Common Rule” and NIH updates for clinical trials research\u003c\/li\u003e\n    \u003cli\u003eQuestions focused specifically on how Risk-Based Quality Management (Section 5 of the Addendum) impacts monitoring activities\u003c\/li\u003e\n    \u003cli\u003eUpdates to state- and country-specific regulations including the U.S., Brazil, Argentina, Peru, India and many others\u003c\/li\u003e\n    \u003cli\u003eOver 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, the Trial Master File, Data Management and many other core clinical research areas\u003c\/li\u003e\n    \u003cli\u003eExtensive graphs and charts on the latest inspection trends and findings! \u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195023356269,"sku":"GCP20E","price":69.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/BookStockImage.jpg?v=1758091733"},{"product_id":"study-site-training-series-2018-volume-4-sponsor-visits-and-regulatory-audits-what-you-need-to-know","title":"Study Site Training Series (2018): Volume 4: Sponsor Visits and Regulatory Audits: What You Need to Know","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003eHere, the several types of visits to study sites and when they each occur is described. Included are examples and learning exercises designed to prepare study site teams for sponsor visits, study closeout, audits and regulatory inspections.\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195023749485,"sku":"SSSV18-4","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover4_364x473_5326f671-5f89-4ef0-b68b-4f3c7d5ab3f5.jpg?v=1758092492"},{"product_id":"study-site-training-series-2018-a-6-volume-self-instructional-training-series-for-investigative-teams","title":"Study Site Training Series (2018): A 6-Volume Self-Instructional Training Series for Investigative Teams","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eDesigned to provide the essentials of roles and responsibilities of the clinical study team as well as the tasks involved, this 6-volume set provides the basics of conducting clinical research in today’s environment. Equipped with exercises and learning activities, each manual can be used as a stand-alone reference or as a complete self-instructional training series.\u003c\/p\u003e\n\u003cp\u003eThe following content is included (by volume): \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVolume 1: The Clinical Study Site Team: Roles and Responsibilities\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis volume is designed to provide readers with an understanding of the roles, responsibilities, and associated tasks of clinical research team members at investigative sites.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVolume 2: FDA Clinical Research Regulations and GCPs: The Essentials\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis volume describes the “rules” and “guidelines” developed by regulatory agencies designed to regulate the conduct of clinical research, emphasizing those requirements that most directly impact investigative site teams.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVolume 3: IRBs\/IECs and Informed Consent: Protecting the Rights of Human Subjects\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis volume includes what investigative site team members need to know regarding protection of the rights and safety of human subjects. In addition to presenting applicable regulations and practical implications, the roles of the IRB\/IEC and the study sponsor are also discussed.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVolume 4: Sponsor Visits and Regulatory Audits: What You Need to Know\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHere, the several types of visits to study sites and when they each occur is described. Included are examples and learning exercises designed to prepare study site teams for sponsor visits, study closeout, audits and regulatory inspections.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVolume 5: Your Role in Reporting Adverse Experiences\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis volume covers how to observe, manage, classify, record and report AEs during clinical studies. It is also intended to familiarize study team members with the many specific procedures required by regulatory agencies to ensure patient safety.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVolume 6: Understanding, Evaluating, and Implementing Clinical Protocols\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis volume is designed to assist teams in protocol implementation. Included are the features of protocols, evaluation strategies, implementation assessment, as well as basic protocol design and writing.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 6-book series can be purchased for $499. To purchase Barnett’s Self-Instructional Study Site Training Series Call: 1-800-856-2556 or Email: customer.service@barnettinternational.com\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eReader Testimonial:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e\"A common sense, practical introduction to the roles of the study coordinator and investigator. It is excellent preparation for anyone at a research site — or at a study sponsor or CRO — who wants to understand how studies are conducted at sites.\"\u003c\/em\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195024601453,"sku":"SSSV181-6","price":499.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_SSASeriesCover1_364x473_9287b77b-2eaf-4f73-ba47-1020685b6ce2.jpg?v=1758092203"},{"product_id":"cra-training-series-volume-4-conducting-the-study-initiation-visits-2018","title":"CRA Training Series: Volume 4 - Conducting the Study Initiation Visits (2018)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"text-decoration: underline;\"\u003eCRA Training Series: Volume 4 - Conducting the Study Initiation Visits\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe fourth volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, focuses on Conducting the Study Initiation Visits. The main purpose of  a study initiation visit is to train the investigator and supporting study staff on the objectives of, and planned methodology for, a clinical study. The study initiation visit is crucial to the clinical investigation of a new drug or device because it provides an opportunity to confirm the approaches to scientific issues and detailed procedural matters before subjects have been enrolled. It is an excellent opportunity to “walk” through all aspects of the study. This volume contains the guidelines for planning, conducting, and documenting a study initiation visit. Specifically, the manual includes the following content:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eObjectives of a study initiation visit and its role in the overall conduct of a clinical study\u003c\/li\u003e\n    \u003cli\u003eThe essential preparations for a successful study initiation visit\u003c\/li\u003e\n    \u003cli\u003eThe tasks that must be performed during the study initiation visit\u003c\/li\u003e\n    \u003cli\u003eExplanation of the necessary documentation and the follow-up steps that must be completed after a study initiation visit has been conducted\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEach volume can be purchased separately or the full 7-volume series can be purchased for $599.\u003c\/p\u003e\n\u003cp\u003ePublications in this set include:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 1: An Overview of Drug Development\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 2: Identifying and Screening Investigators\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 3: Conducting the Prestudy Visit\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 4: Conducting the Study Initiation Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 5: Conducting Routine Monitoring Visits\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 6: The CRA's Reference for Adverse Events\u003c\/strong\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003cstrong\u003eVolume 7: Test Your CRA Knowledge\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv\u003e\u003cem\u003e“Excellent preparation for a CRA career and also useful for study managers, investigators, and study coordinators who want to work more effectively with CRAs.\"\u003c\/em\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e- Norman M. Goldfarb, Managing Director, First Clinical Research LLC\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cstrong\u003e\u003cbr\u003e\n\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003eCheck out the other volumes in the series:\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_01.jpg\" alt=\"CRA Series 2018 Vol 1\" title=\"CRA Series 2018 Vol 1\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_02.jpg\" alt=\"CRA Series 2018 Vol 2\" title=\"CRA Series 2018 Vol 2\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_03.jpg\" alt=\"CRA Series 2018 Vol 3\" title=\"CRA Series 2018 Vol 3\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_04.jpg\" alt=\"CRA Series 2018 Vol 4\" title=\"CRA Series 2018 Vol 4\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_05.jpg\" alt=\"CRA Series 2018 Vol 5\" title=\"CRA Series 2018 Vol 5\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_06.jpg\" alt=\"CRA Series 2018 Vol 6\" title=\"CRA Series 2018 Vol 6\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"col-sm-3\"\u003e\u003cimg src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/Publications\/CRA-Series-Covers-2018_07.jpg\" alt=\"CRA Series 2018 Vol 7\" title=\"CRA Series 2018 Vol 7\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195025453421,"sku":"CRAV418","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2018_CRASeriesCover4_364x473_ce7d5592-2e5c-46b9-a0be-d713a15f311a.jpg?v=1758091468"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2020\/2021","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eThis industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded guide includes:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eContinued updates focused on the impact of changes to ICH GCP E6 R2, enforcement of the revisions and its impact on clinical trial processes and systems, including Quality-by-Design and Risk-Based Quality Management (QM) expectations\u003c\/li\u003e\n    \u003cli\u003eChanges resulting from the implementation of the Common Rule including changes in informed consent requirements, the impact of Annex 13 on investigational product management\u003c\/li\u003e\n    \u003cli\u003eImpact of GDPR on eTMF management and common TMF regulatory findings\u003c\/li\u003e\n    \u003cli\u003eDozens of new Q\u0026amp;As including changes resulting from COVID-19\u003c\/li\u003e\n    \u003cli\u003eNew questions focused specifically on how Risk-based Quality Management (Section 5 of the Addendum) impacts monitoring activities\u003c\/li\u003e\n    \u003cli\u003eUpdates on the EU’s General Data Protection Regulation (GDPR) regulation and the MHRA 2018 Data Integrity Guidance\u003c\/li\u003e\n    \u003cli\u003eCoverage on updates to the “Common Rule” and NIH updates for clinical trials research\u003c\/li\u003e\n    \u003cli\u003eQuestions focused specifically on how Risk-Based Quality Management (Section 5 of the Addendum) impacts monitoring activities\u003c\/li\u003e\n    \u003cli\u003eUpdates to state- and country-specific regulations including the U.S., Brazil, Argentina, Peru, India and many others\u003c\/li\u003e\n    \u003cli\u003eOver 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, the Trial Master File, Data Management and many other core clinical research areas\u003c\/li\u003e\n    \u003cli\u003eExtensive graphs and charts on the latest inspection trends and findings! \u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195025518957,"sku":"GCP20","price":79.95,"currency_code":"USD","in_stock":true}]},{"product_id":"good-clinical-practice-a-question-answer-reference-guide-2026-2027","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2026\/2027","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cdiv class=\"leftColumn\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/Barnett_GCP_Q_A_2026_TOC_1.pdf?v=1770058542\" title=\"Barnett's GCP Q\u0026amp;A Guide 2026\/2027 Table of Contents\"\u003eView the Table of Contents\u003c\/a\u003e\u003c\/p\u003e\n\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cmeta charset=\"utf-8\"\u003e\n\u003cdiv data-widget_type=\"heading.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"cc7e0ae\" class=\"elementor-element elementor-element-cc7e0ae elementor-widget elementor-widget-heading\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003ch4 class=\"elementor-heading-title elementor-size-default\"\u003eA comprehensive, practice-focused GCP reference used by clinical research professionals to interpret and apply global GCP standards in real-world trial environments.\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"d0ea8c5\" class=\"elementor-element elementor-element-d0ea8c5 elementor-widget elementor-widget-text-editor\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003cp data-end=\"1112\" data-start=\"756\"\u003eFor decades,\u003cspan\u003e \u003c\/span\u003e\u003cem data-end=\"830\" data-start=\"769\"\u003eGood Clinical Practice: A Question \u0026amp; Answer Reference Guide\u003c\/em\u003e\u003cspan\u003e \u003c\/span\u003ehas served as a trusted resource for navigating the practical application of GCP. Rather than restating regulations, the guide addresses the real questions that arise during trial execution, oversight, and inspection readiness — especially where guidance is open to interpretation.\u003c\/p\u003e\n\u003cp data-end=\"1252\" data-start=\"1114\"\u003eThe\u003cspan\u003e \u003c\/span\u003e\u003cstrong data-end=\"1139\" data-start=\"1118\"\u003e2026\/2027 edition\u003c\/strong\u003e\u003cspan\u003e \u003c\/span\u003ereflects how GCP expectations are being evaluated today, across increasingly complex and global clinical trials.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\nThe publication is shaped by experts with deep experience in clinical operations, quality, regulatory compliance, and inspection readiness across global trials.  Check out the editorial team and expert advisory panel listed below.   \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cdiv data-e-type=\"container\" data-element_type=\"container\" data-id=\"d07fc99\" class=\"elementor-element elementor-element-d07fc99 e-con-full e-grid e-con e-child\"\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"1684f3d\" class=\"elementor-element elementor-element-1684f3d elementor-widget elementor-widget-text-editor\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eEditor-in-Chief: Donna W. Dorozinsky, RN, MSN, CCRC, Founder \u0026amp; CEO, Just In Time GCP\u003c\/i\u003e\u003c\/b\u003e\u003cb\u003e\u003ci\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli class=\"p1\"\u003eCourtney Bryant, MBA, Vice President, Program Management, QurAlis\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eNikki Christison, BS, CCRA, IACR, Principal, Clinical Resolutions\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eKeith Dorricott, BSc, MBB, Director, Dorricott Metrics \u0026amp; Process Improvement Ltd.\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eDeborah A. Guattery, BSN, MJ, RN, GCP Quality Expert, Chase the Sky for Quality\u003c\/li\u003e\n\u003cli class=\"p2\"\u003eMichael R. Hamrell, PhD, RAC, FRAPS, CCRA, FRACP, RQAP-GCP, MORIAH Consultants (former Editor-in-Chief)\u003c\/li\u003e\n\u003cli class=\"p2\"\u003eJonathan Heinemann, Executive Director, Clinical Quality Assurance, INHIBRx, Inc.\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eJoseph G. Iacobucci RPh MBA, Principal, Integrated Clinical Supplies LLC\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eTrish Landry, MBA, RAC, CCRP, Sr. Vice President, Beaufort CRO\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eSusan M. Leister, MBA, PhD, CQA, CSSBB, Vice President, Quality \u0026amp; Compliance, TRI, Inc.\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eAvery Miles, Director, Privacy, Quest Diagnostics\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eHeather Murphy, RN, MBA, CQA, Founder and CEO, HMGlobal Pharmacovigilance Consulting, LLC\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eAnastassia Negrouk, Chief Operating Officer, MyData-Trust\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eElizabeth Ronk Nelson, MPH, President, Regulatory Risk Management\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eDawn Niccum, RN\/MSN, RQAP, CCRA, PMP, Executive Vice President, Q\u0026amp;A Compliance, InSeption\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eAlberto Pacheco, Independent Consultant\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eDenise G. Redkar-Brown, MT., Independent Consultant\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eSharon S. Reinhard, MS, Independent Quality Consultant\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eLeslie Sam, BA, CQIA, CSSBB, President, Leslie Sam and Associates, LLC\u003c\/li\u003e\n\u003cli class=\"p1\"\u003e\u003cem style=\"font-family: -apple-system, BlinkMacSystemFont, 'San Francisco', 'Segoe UI', Roboto, 'Helvetica Neue', sans-serif; font-size: 0.875rem;\"\u003eEditor Emeritus: Mark Mathieu, PAREXEL International Corporation\u003c\/em\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"ccfa170\" class=\"elementor-element elementor-element-ccfa170 elementor-widget elementor-widget-text-editor\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003cmeta charset=\"utf-8\"\u003e\n\u003cp\u003e\u003cb style=\"background-color: transparent; color: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit;\"\u003eSome highlights of the completely updated guide include:\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-end=\"1227\" data-start=\"1166\"\u003eAn authoritative Q\u0026amp;A reference for applying GCP in practice, addressing \u003cspan\u003ethe full scope of modern GCP expectations\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1288\" data-start=\"1230\"\u003eGrounded in real-world experience and expert perspectives\u003c\/li\u003e\n\u003cli data-end=\"1364\" data-start=\"1291\"\u003eDesigned to support oversight, accountability, and inspection readiness\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe publication is a working reference — not a training manual or checklist!  \u003cstrong\u003eOrder your copy today! The single copy price is $159. Please contact Barnett for bulk purchases at customer.service@barnettinternational.com.\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"GCP2627","offer_id":52999286784365,"sku":null,"price":159.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/GCP-Cover-2026_400-x-514_1.jpg?v=1770057663"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide-2026-2027-electronic-edition","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2026\/2027 (Electronic Edition)","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cdiv class=\"leftColumn\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/Barnett_GCP_Q_A_2026_TOC_1.pdf?v=1770058542\" title=\"Barnett's GCP Q\u0026amp;A Guide 2026\/2027 Table of Contents\"\u003eView the Table of Contents\u003c\/a\u003e\u003c\/p\u003e\n\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cmeta charset=\"utf-8\"\u003e\n\u003cdiv data-widget_type=\"heading.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"cc7e0ae\" class=\"elementor-element elementor-element-cc7e0ae elementor-widget elementor-widget-heading\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003ch4 class=\"elementor-heading-title elementor-size-default\"\u003eA comprehensive, practice-focused GCP reference used by clinical research professionals to interpret and apply global GCP standards in real-world trial environments.\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"d0ea8c5\" class=\"elementor-element elementor-element-d0ea8c5 elementor-widget elementor-widget-text-editor\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003cp data-end=\"1112\" data-start=\"756\"\u003eFor decades,\u003cspan\u003e \u003c\/span\u003e\u003cem data-end=\"830\" data-start=\"769\"\u003eGood Clinical Practice: A Question \u0026amp; Answer Reference Guide\u003c\/em\u003e\u003cspan\u003e \u003c\/span\u003ehas served as a trusted resource for navigating the practical application of GCP. Rather than restating regulations, the guide addresses the real questions that arise during trial execution, oversight, and inspection readiness — especially where guidance is open to interpretation.\u003c\/p\u003e\n\u003cp data-end=\"1252\" data-start=\"1114\"\u003eThe\u003cspan\u003e \u003c\/span\u003e\u003cstrong data-end=\"1139\" data-start=\"1118\"\u003e2026\/2027 edition\u003c\/strong\u003e\u003cspan\u003e \u003c\/span\u003ereflects how GCP expectations are being evaluated today, across increasingly complex and global clinical trials.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\nThe publication is shaped by experts with deep experience in clinical operations, quality, regulatory compliance, and inspection readiness across global trials.  Check out the editorial team and expert advisory panel listed below.   \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cdiv data-e-type=\"container\" data-element_type=\"container\" data-id=\"d07fc99\" class=\"elementor-element elementor-element-d07fc99 e-con-full e-grid e-con e-child\"\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"1684f3d\" class=\"elementor-element elementor-element-1684f3d elementor-widget elementor-widget-text-editor\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eEditor-in-Chief: Donna W. Dorozinsky, RN, MSN, CCRC, Founder \u0026amp; CEO, Just In Time GCP\u003c\/i\u003e\u003c\/b\u003e\u003cb\u003e\u003ci\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli class=\"p1\"\u003eCourtney Bryant, MBA, Vice President, Program Management, QurAlis\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eNikki Christison, BS, CCRA, IACR, Principal, Clinical Resolutions\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eKeith Dorricott, BSc, MBB, Director, Dorricott Metrics \u0026amp; Process Improvement Ltd.\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eDeborah A. Guattery, BSN, MJ, RN, GCP Quality Expert, Chase the Sky for Quality\u003c\/li\u003e\n\u003cli class=\"p2\"\u003eMichael R. Hamrell, PhD, RAC, FRAPS, CCRA, FRACP, RQAP-GCP, MORIAH Consultants (former Editor-in-Chief)\u003c\/li\u003e\n\u003cli class=\"p2\"\u003eJonathan Heinemann, Executive Director, Clinical Quality Assurance, INHIBRx, Inc.\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eJoseph G. Iacobucci RPh MBA, Principal, Integrated Clinical Supplies LLC\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eTrish Landry, MBA, RAC, CCRP, Sr. Vice President, Beaufort CRO\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eSusan M. Leister, MBA, PhD, CQA, CSSBB, Vice President, Quality \u0026amp; Compliance, TRI, Inc.\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eAvery Miles, Director, Privacy, Quest Diagnostics\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eHeather Murphy, RN, MBA, CQA, Founder and CEO, HMGlobal Pharmacovigilance Consulting, LLC\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eAnastassia Negrouk, Chief Operating Officer, MyData-Trust\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eElizabeth Ronk Nelson, MPH, President, Regulatory Risk Management\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eDawn Niccum, RN\/MSN, RQAP, CCRA, PMP, Executive Vice President, Q\u0026amp;A Compliance, InSeption\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eAlberto Pacheco, Independent Consultant\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eDenise G. Redkar-Brown, MT., Independent Consultant\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eSharon S. Reinhard, MS, Independent Quality Consultant\u003c\/li\u003e\n\u003cli class=\"p1\"\u003eLeslie Sam, BA, CQIA, CSSBB, President, Leslie Sam and Associates, LLC\u003c\/li\u003e\n\u003cli class=\"p1\"\u003e\u003cem style=\"font-family: -apple-system, BlinkMacSystemFont, 'San Francisco', 'Segoe UI', Roboto, 'Helvetica Neue', sans-serif; font-size: 0.875rem;\"\u003eEditor Emeritus: Mark Mathieu, PAREXEL International Corporation\u003c\/em\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"ccfa170\" class=\"elementor-element elementor-element-ccfa170 elementor-widget elementor-widget-text-editor\"\u003e\n\u003cdiv class=\"elementor-widget-container\"\u003e\n\u003cmeta charset=\"utf-8\"\u003e\n\u003cp\u003e\u003cb style=\"background-color: transparent; color: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit;\"\u003eSome highlights of the completely updated guide include:\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-end=\"1227\" data-start=\"1166\"\u003eAn authoritative Q\u0026amp;A reference for applying GCP in practice, addressing \u003cspan\u003ethe full scope of modern GCP expectations\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1288\" data-start=\"1230\"\u003eGrounded in real-world experience and expert perspectives\u003c\/li\u003e\n\u003cli data-end=\"1364\" data-start=\"1291\"\u003eDesigned to support oversight, accountability, and inspection readiness\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe publication is a working reference — not a training manual or checklist!  \u003cstrong\u003eOrder your copy today! The price for the electronic edition is $149. For team access, contact Barnett at customer.service@barnettinternational.com.\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"GCP2627E","offer_id":52999286423917,"sku":null,"price":149.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/GCP-Cover-2026_400-x-514_1.jpg?v=1770057663"}],"url":"https:\/\/www.barnettinternational.com\/collections\/regulatory-guides.oembed","provider":"Barnett International ","version":"1.0","type":"link"}