{"title":"Data Management in the Electronic Data Capture Arena","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 program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process. Although the basic data management principles remain the same, for example good CRF design and ensuring\u003cbr\u003e\nthe integrity of the data, the timelines and tasks surrounding today’s EDC are not interpreted exactly as the paper CRF process has previously dictated. The understanding of how the technology has changed the process will enable today’s Data Managers to move forward in the discipline and ensure their place as viable members of the clinical study team. As electronic data capture utilized as patient e-source or eCRF becomes more the routine, it is important that the CDM be fully aware of the capabilities of the EDC application\u003cbr\u003e\nin order to ensure a comprehensive data management component in the clinical trial conduct.\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 class=\"Abstract\"\u003e\n\u003cli\u003eAssess the impact of the regulations on Data Management \u003c\/li\u003e\n\u003cli\u003eDiscuss the rationale and enhancements regarding the utilization of EDC\u003c\/li\u003e\n\u003cli\u003eDiscuss in-depth the changing role of the Clinical Data Manager\u003c\/li\u003e\n\u003cli\u003eOutline the CDM focus on protocol review and CRF design\u003c\/li\u003e\n\u003cli\u003eEmploy “best practices” for eCRF design\u003c\/li\u003e\n\u003cli\u003eDescribe the Data Management documentation required in clinical trial conduct\u003c\/li\u003e\n\u003cli\u003eIdentify EDC system enhancements for the industry\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 class=\"Abstract\"\u003e\n\u003cli\u003eClinical Operations and Project Management Personnel who need to familiarize themselves with the process of EDC set-up requirements and the role that utilizing EDC plays in the conduct of clinical trials.\u003c\/li\u003e\n\u003cli\u003eClinical Data Managers (CDMs) who are involved in the transition of paper CRF process to EDC\u003c\/li\u003e\n\u003cli\u003eCDMs new to the EDC process\u003c\/li\u003e\n\u003cli\u003eEDC developers who require a better understanding of the CDM process and role\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 class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eThe Regulatory Environment for the Utilization\/Consideration of EDC:\u003c\/b\u003e Overall review of the 21 CFR Part 11 regulations; e-signature requirements for FDA, EU, and Japan\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eTransitioning from Paper CRF to EDC:\u003c\/b\u003e Examine the considerations surrounding the adoption of EDC while still working in a paper environment\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eThe Changing Role of the CDM:\u003c\/b\u003e The CDM was process driven, whereas the EDC environment has moved the focus from process to Project Management\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eStudy Start-up, Protocol Synopsis Review, eCRF Development:\u003c\/b\u003e Examine the activities associated with the study start-up in an EDC environment;discuss eCRF development and also the impact that CDISC\/CDASH may have on future CDM endeavors\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eBest Practices in eCRF Development:\u003c\/b\u003e Review the best practices as they relate to EDC activities and the issues surrounding eCRF creation\/testing\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 class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eUser Acceptance Testing (UAT):\u003c\/b\u003e How does the application work? How do we test it or try to “break” it?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eCreating the Data Management Plan:\u003c\/b\u003e The documentation required for a robust DMP when utilizing an EDC application; reviewing the components of the DMP as described by the Society of Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP)\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eAncillary Documentation for EDC:\u003c\/b\u003e What do we need for training the users in the application? Navigation documentation, query resolution hints, report generation\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eExternal Electronic Data:\u003c\/b\u003e Lab data, ECG data – can the application accept data uploads?\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eOutsourcing EDC DM Issues:\u003c\/b\u003e Vendor outsourcing, discussion surrounding evaluation of vendors for total CDM projects or vendor development of eCRFs\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 class=\"Abstract\"\u003e\n\u003cli\u003eReview a simple protocol synopsis and plan to design a simple eCRF\u003c\/li\u003e\n\u003cli\u003eUtilize a “training” database in an EDC application to review navigation and discuss site training issues\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# 0778-0000-15-044-L01-P. Released: 10\/15.\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\/data-management-in-the-electronic-data-capture-arena.oembed","provider":"Barnett International ","version":"1.0","type":"link"}