{"title":"Medical Device","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":"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":"medical-device-development-regulation-and-law-2020","title":"Medical Device Development: Regulation and Law (2020)","description":"\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eMedical Device Development: Regulation and Law, 2020 Edition\u003c\/b\u003e, is the must-have practical reference for regulatory affairs professionals. This authoritative text provides the most comprehensive and updated analysis of U.S. medical device and diagnostics development and approval requirements anywhere. The new edition offers analysis of new FDA device regulations, including all new significant guidance documents, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the United States.  \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eUpdate on the new medical device provisions of the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act of 2017.\u003c\/li\u003e\n\u003cli\u003eNew statutory provisions and guidance documents related to regulation of software as a medical device, digital health\/machine learning, cybersecurity, general wellness products, real-world evidence, use of benefit risk information for both premarket and post-market processes, and when post-clearance changes require submission of a new 510(k) notice.\u003c\/li\u003e\n\u003cli\u003eUpdate on the new TPLC organizational structure of CDRH.\u003c\/li\u003e\n\u003cli\u003eUpdates to the pre-submission process, including new MDUFA IV goals for meetings and feedback.\u003c\/li\u003e\n\u003cli\u003eUpdates to FDA’s “refusal to accept” and review policies relating to 510(k)s, PMAs, and pre-submissions.\u003c\/li\u003e\n\u003cli\u003eUpdate on the investigational device exemption process including new guidance documents and policies related to clinical trials, including IDE benefit-risk considerations, new Good Clinical Practices (GCPs) guidance and policy for use of foreign data, policies regarding ClinicalTrials.gov registration, as well as guidance documents on adaptive design, leveraging data for pediatric use, and demographic factors in clinical studies.\u003c\/li\u003e\n\u003cli\u003eChanges to the premarket approval application process including FDA guidance on distinguishing between 30-Day Notice PMA Supplements and Site Change PMA Supplements.\u003c\/li\u003e\n\u003cli\u003eNew policies and guidance documents concerning in vitro diagnostic products, including updates on research and investigational use and laboratory developed tests.\u003c\/li\u003e\n\u003cli\u003eUpdate on device compliance issues, including the 2016 medical device reporting guidance.\u003c\/li\u003e\n\u003cli\u003eNew guidance documents, statutory changes, and cases relating to combination products incorporating medical devices.\u003c\/li\u003e\n\u003cli\u003eNew changes to FDA’s review of requests for issuance of certificates to foreign governments.\u003c\/li\u003e\n\u003cli\u003eFDA policy regarding the regulation of third party reprocessors. \u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eApprox. 600 pages\u003cbr\u003eRegular Price $195\u003cbr\u003eStudent Price $95\u003cbr\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eReader Testimonial:\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003e\u003ci\u003e“I can safely say this is the most practical and comprehensive book on the subject of FDA regulation of medical devices. This edition includes a detailed but understandable review of all the key device regulatory issues faced by the device industry as well as an up-to-date device regulation such as the new Cures Act provisions relating to medical device software and the most recent developments in the regulation of combination products.”  \u003c\/i\u003e  \u003c\/p\u003e\u003cdiv\u003e\n\u003cb\u003e \u003c\/b\u003e\u003cb\u003eMary Monovoukas, \u003c\/b\u003e\u003cb\u003eVP, Chief Global Regulatory and Privacy \u003c\/b\u003e\u003cb\u003eCounsel, Boston Scientific Corporation\u003c\/b\u003e  \u003c\/div\u003e\u003cdiv\u003e \u003cb\u003eAbout the authors:\u003c\/b\u003e\n\u003c\/div\u003e\u003cp\u003eJonathan S. Kahan, Partner, Hogan Lovells US LLP is based in Washington, D.C. Jon is a co-director of the firm’s food, drug, medical device, and agriculture group, and has been practicing in FDA law for 40 years. Jon is also an Adjunct Professor at the George Washington University Law School teaching medical device law. His practice focuses primarily on assisting medical device companies in navigating the U.S. Food and Drug Administration (FDA) regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices, and biologics. In addition to the daily counseling of clients in FDA-related matters, he represents many clients in administrative hearings and trials, and in the federal courts. Jon has published numerous law review and other articles concerning FDA regulatory issues.\u003c\/p\u003e\u003cp\u003eMichael S. Heyl, Partner, Hogan Lovells US LLP served as a co-author and lead editor for this book. Mike helps medical device companies through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA's Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans. He represents large multinational corporations facing FDA and criminal enforcement, and helps small start-ups develop and implement post-market compliance programs. Because he understands FDA's requirements for importing and exporting medical devices, Mike is frequently called on to negotiate the release of detained goods being imported to the U.S. Mike also works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions and initial public offerings. He has been involved with numerous transactions ranging from multi-billion dollar acquisitions to the negotiation of supply and distribution agreements.\u003c\/p\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52142537703789,"sku":"MEDDEV20","price":195.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2019_MedicalDevices_364x522_33ccec70-90b0-4efe-9544-eabe02530a9b.jpg?v=1758091928"},{"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":"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":"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":"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"}],"url":"https:\/\/www.barnettinternational.com\/collections\/medical-device.oembed","provider":"Barnett International ","version":"1.0","type":"link"}