{"title":"Introduction to Clinical Data Management","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseDescription.jpg?n=8101\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThis course provides an excellent introduction to clinical data management in the pharmaceutical industry. Its focus on processes and their rationale renders it ideal for the new data manager and to other individuals who wish to learn basic clinical data management skills and the function of clinical data management in the medical product development process.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eUnderstand the medical product and study development process and the regulations that govern the clinical research process\u003c\/li\u003e\n\u003cli\u003eIdentify the roles and responsibilities of the clinical research team\u003c\/li\u003e\n\u003cli\u003eDiscuss the protocol design and development process\u003c\/li\u003e\n\u003cli\u003eReview the CDM Start-up activities\/documentation\u003c\/li\u003e\n\u003cli\u003eAnalyze case report form design, data tracking and collection, data entry and capture\u003c\/li\u003e\n\u003cli\u003eDiscuss data review, validation, and queries\u003c\/li\u003e\n\u003cli\u003eComprehend the rationale of the MedDRA dictionary\u003c\/li\u003e\n\u003cli\u003eIdentify the role that CDISC and CDASH play in the standardization of data collection and reporting\u003c\/li\u003e\n\u003cli\u003eUnderstand quality control and quality assurance\u003c\/li\u003e\n\u003cli\u003eDiscuss database lock and release\u003c\/li\u003e\n\u003cli\u003eUnderstand adverse event reporting and reconciliation\u003c\/li\u003e\n\u003cli\u003eIdentify the changing CDM role towards project management and the issues associated with managing mega-trials and CROs\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eStaff of Pharmaceutical Companies, Contract or Independent Research Organizations whose function is to review, correct, enter, or manage data, with less than one year of experience in that function\u003c\/li\u003e\n\u003cli\u003eIndividuals who desire a basic understanding of the function of clinical data management in the medical product development process\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eDenise G. Redkar-Brown, MT\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?n=2216\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eIntroduction to Medical Product Development:\u003c\/b\u003e Good clinical practice – purpose and history; roles and responsibilities of the FDA\/ICH; phases of medical development research and development\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eOverview of Clinical Data Management:\u003c\/b\u003e Data management core processes and data flow; roles and responsibilities within clinical data  management; interfaces with other disciplines within clinical research and development\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eProtocol and Design:\u003c\/b\u003e Good clinical study; steps in protocol development; designing a clinical trial; protocol elements and modifications\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eStudy Start-Up – A Clinical Data Management Perspective:\u003c\/b\u003e Study documentation; data handling manual; annotated case report form and database design; remote data management\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eCase Report Form Design and Development:\u003c\/b\u003e Standard and study specific case report form modules; organization of a case report form; CRF design guidelines; data collection methods; CRF tracking; data capture, flow and entry; remote data capture\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 2: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eData Review and Validation:\u003c\/b\u003e Data errors; frequently encountered problems; identifying and developing data checks; data queries\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eCoding:\u003c\/b\u003e Purpose of coding; common coding dictionaries; computerized coding (autoencoding); coding philosophies\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eQuality Control and Quality Assurance:\u003c\/b\u003e Roles of quality control and quality assurance; audits and documentation\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eDatabase Release and Lock:\u003c\/b\u003e Study close-out and database release; lock and unlock\u003c\/li\u003e\n\u003cli\u003eAdverse Event (AE) Reporting: Definitions; describing and documenting AEs; collecting AE data\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eCore Definitions and Concepts\u003c\/li\u003e\n\u003cli\u003eTo “Split” or Not to Split\u003c\/li\u003e\n\u003cli\u003eIdentifying Data Checks\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\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# 0778-0000-13-034-L01-P. Released: 10\/13.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/introduction-to-clinical-data-management.oembed","provider":"Barnett International ","version":"1.0","type":"link"}