{"title":"Auditing Techniques for Clinical Research Professionals","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records\n    (EMR) and\/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations.  Significant\n    updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient \u0026amp; Effective QS processes that clinical site personnel can utilize\n    and how monitors and auditors can help them develop and implement them.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eApply auditing standards based in current law, regulations, and guidelines\u003c\/li\u003e\n\u003cli\u003eUtilize electronic systems to enhance your auditing techniques, allowing more efficiency in your daily monitoring or auditing activities\u003c\/li\u003e\n\u003cli\u003eUnderstand the role of quality systems in GCP, including techniques for detecting root causes of performance deficiencies and developing and implementing effective Corrective and Preventive Action (CAPA)\u003c\/li\u003e\n\u003cli\u003eSelect investigators and records for auditing or special monitoring emphasis\u003c\/li\u003e\n\u003cli\u003eConduct clinical investigator audits\u003c\/li\u003e\n\u003cli\u003eDetect, prove, and prevent scientific fraud and misconduct\u003c\/li\u003e\n\u003cli\u003eLearn techniques for writing audit plans and reports\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eClinical Quality Assurance Professionals who audit the quality of clinical trials\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates and Managers, Project Leaders, and Medical Monitors who want to enhance their effectiveness\n    \u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals responsible for GCP regulatory compliance\u003c\/li\u003e\n\u003cli\u003eInvestigators, Study Coordinators and Trial Center Managers who want to learn how to prepare for FDA and sponsor audits and to improve the quality of their research activities\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\n\u003c\/p\u003e\u003cp\u003eElizabeth Ronk Nelson, M.P.H.\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer\nbiographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eThe Standards: Important aspects of GCP-related\n     law and regulations:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eFood, Drug, and Cosmetic Act, Title 18 Criminal\n     Statutes, HIPAA, 21CFR 11, 50, 54, 56, 312, and 812; Corporate standards\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eTrial Center Auditing Methods:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eSelecting centers to audit, auditing and inspection procedures\n     and methodology, including special procedures for “e-trials”; differences between\n     auditing and monitoring; Defining and determining the adequacy of source documentation;\n     developing and implementing Simple, Effective, and Efficient Quality Systems\n     to improve clinical site performance\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eFraud and Misconduct:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eMotives; discovering, reporting, and preventing fraud and\n     misconduct, including special techniques for e-trials\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two\n\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eData Trend Analysis:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefinition and description of this special auditing\n     technique; multiple examples; how to practically use this technique;\n     Special subsection on detecting the signs and symptoms of impeding failure\n     at a trial center\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eAuditing Techniques Exercise:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePerform data trend analysis; audit to determine document\n     validity and data accuracy; perform root cause analysis; build a CAPA;\n     work individually and within a group of your peers\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eEssential Documents:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefine and prioritize; auditing the essential document\n     binder or files; the legal and regulatory basis behind the EDs\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eEnforcers and Enforcement:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eThe compliance organizations in CDER, CBER and CDRH; FDA\n     inspection results and consequences of adverse findings; how to manage a\n     regulatory authority inspection; FDA’s Application Integrity Policy\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003eSummary of Auditing and QS Processes:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eAudit Planning, Notifications, Conduct, Reporting; Root\n     Cause Analysis; developing and implementing CAPAs\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003ePerform Data Trend Analysis\u003c\/li\u003e\n\u003cli\u003eAccomplish an Audit of Source Documents and CRFs\u003c\/li\u003e\n\u003cli\u003eWork on an Audit Team to Discuss and Present Findings\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cdiv\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/div\u003e\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\u003cdiv\u003e\n\u003cp\u003eSpecial rates are available for multiple attendees from the same organization.  Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e\n\u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar\ncancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003c\/div\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including\n    the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-016-L99-P. Released: 3\/25. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003e \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[{"product_id":"auditing-techniques-for-clinical-research-professionals-2026-06-04","title":"Auditing Techniques for Clinical Research Professionals","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and\/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient \u0026amp; Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eApply auditing standards based in current law, regulations, and guidelines\u003c\/li\u003e \u003cli\u003eUtilize electronic systems to enhance your auditing techniques, allowing more efficiency in your daily monitoring or auditing activities\u003c\/li\u003e \u003cli\u003eUnderstand the role of quality systems in GCP, including techniques for detecting root causes of performance deficiencies and developing and implementing effective Corrective and Preventive Action (CAPA)\u003c\/li\u003e \u003cli\u003eSelect investigators and records for auditing or special monitoring emphasis\u003c\/li\u003e \u003cli\u003eConduct clinical investigator audits\u003c\/li\u003e \u003cli\u003eDetect, prove, and prevent scientific fraud and misconduct\u003c\/li\u003e \u003cli\u003eLearn techniques for writing audit plans and reports\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Quality Assurance Professionals who audit the quality of clinical trials\u003c\/li\u003e \u003cli\u003eClinical Research Associates and Managers, Project Leaders, and Medical Monitors who want to enhance their effectiveness \u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals responsible for GCP regulatory compliance\u003c\/li\u003e \u003cli\u003eInvestigators, Study Coordinators and Trial Center Managers who want to learn how to prepare for FDA and sponsor audits and to improve the quality of their research activities\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors: \u003c\/p\u003e\u003cp\u003eElizabeth Ronk Nelson, M.P.H.\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eThe Standards: Important aspects of GCP-related law and regulations:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eFood, Drug, and Cosmetic Act, Title 18 Criminal Statutes, HIPAA, 21CFR 11, 50, 54, 56, 312, and 812; Corporate standards\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eTrial Center Auditing Methods:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eSelecting centers to audit, auditing and inspection procedures and methodology, including special procedures for \"e-trials\"; differences between auditing and monitoring; Defining and determining the adequacy of source documentation; developing and implementing Simple, Effective, and Efficient Quality Systems to improve clinical site performance\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eFraud and Misconduct:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eMotives; discovering, reporting, and preventing fraud and misconduct, including special techniques for e-trials\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two \u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eData Trend Analysis:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefinition and description of this special auditing technique; multiple examples; how to practically use this technique; Special subsection on detecting the signs and symptoms of impeding failure at a trial center\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eAuditing Techniques Exercise:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePerform data trend analysis; audit to determine document validity and data accuracy; perform root cause analysis; build a CAPA; work individually and within a group of your peers\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eEssential Documents:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefine and prioritize; auditing the essential document binder or files; the legal and regulatory basis behind the EDs\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eEnforcers and Enforcement:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eThe compliance organizations in CDER, CBER and CDRH; FDA inspection results and consequences of adverse findings; how to manage a regulatory authority inspection; FDA's Application Integrity Policy\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eSummary of Auditing and QS Processes:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eAudit Planning, Notifications, Conduct, Reporting; Root Cause Analysis; developing and implementing CAPAs\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003ePerform Data Trend Analysis\u003c\/li\u003e \u003cli\u003eAccomplish an Audit of Source Documents and CRFs\u003c\/li\u003e \u003cli\u003eWork on an Audit Team to Discuss and Present Findings\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cdiv\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/div\u003e\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\u003cdiv\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e \u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e \u003c\/div\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-016-L99-P. Released: 3\/25. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003e \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":52823797563757,"sku":"SFCJ0626","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":52823797596525,"sku":"SFCJ0626-ACADEMIC","price":1495.0,"currency_code":"USD","in_stock":true}]}],"url":"https:\/\/www.barnettinternational.com\/collections\/auditing-techniques-for-clinical-research-professionals.oembed","provider":"Barnett International ","version":"1.0","type":"link"}