{"title":"Data Management: Key Regulations Impacting the Role of the Clinical Data Manager","description":"\u003cp\u003e\u003cimg title=\"Course Description\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIn conducting clinical research, there are some specific regulations that directly impact the discipline of Clinical Data Management (CDM). 21 CFR Part 11 includes mandatory regulations that govern clinical trials data. It requires a system in which electronic records and signatures are trustworthy, reliable, and secure; electronic signatures that are equivalent to paper records and handwritten signatures executed on paper; a system that discerns invalid or altered records; and signatures that are linked to an electronic record. The “Guidance for Industry—Computerized Systems Used in Clinical Trials,” builds on the importance of information inclusion when utilizing computerized systems. In addition, the recently finalized “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” specifically mentions the role that Clinical Data Management is expected to have in assisting in a risk-based monitoring approach. In this web seminar, we will explore the information in these regulations\/guidances that will further the understanding of their impact on our current way of working. \u003cbr\u003e\u003cbr\u003e\u003cimg title=\"Learning Objectives\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/LearningObjectives.jpg?n=4499\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDefine the 21 CFR Part 11 regulations as they impact Clinical Data Management\u003c\/li\u003e\n\u003cli\u003eDescribe what is meant by an electronic signature\u003c\/li\u003e\n\u003cli\u003eList components defining “computerized systems”\u003c\/li\u003e\n\u003cli\u003eIdentify the Clinical Data Manager’s role in risk-based monitoring\u003c\/li\u003e\n\u003cli\u003eExamine eSource Implementation from a CDM perspective\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eClinical Data Managers\u003c\/li\u003e\n\u003cli\u003eClinical Research Professionals\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/Instructor.jpg?n=9798\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDenise G. Redkar-Brown, MT\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cfont color=\"#800080\"\u003eClick here for complete trainer biographies\u003c\/font\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e$695\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIncludes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\" border=\"0\"\u003e\u003cbr\u003e\u003cbr\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 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#: 0778-0000-17-024-L01-P. Released: 5\/17. \u003c\/p\u003e\n\u003cp align=\"center\" class=\"Abstract\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at \u003c\/strong\u003e\u003c\/font\u003e\u003cspan style=\"text-align: left;\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003e+1 215.413.2471. \u003c\/strong\u003e\u003c\/font\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/data-management-key-regulations-impacting-the-role-of-the-clinical-data-manager.oembed","provider":"Barnett International ","version":"1.0","type":"link"}