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Selecting and Implementing Electronic Data Capture (EDC1) 2021

Selecting and Implementing Electronic Data Capture (EDC1) March 8 - April 3, 2021 https://www.pathlms.com/scdm/courses/... Overview: The course will address evaluation of systems, user requirements, and process change and implementation of systems, as well as training. A sample protocol will provide application of learning to real world situations. Over four weeks, this course will address general principles, best practice and issues to consider for choosing and implementing an EDC platform. The focus will be on the choices required to meet the business needs of an organization, whether using EDC as a sponsor directly with an EDC vendor or a sponsor partnered with a CRO. Topics will include designing the application to interface with other data components such as ePRO, IVRS and Central Labs. Participants will gain insightful examples of how to perform and document UAT; set up EDC users, roles and permissions; and to comply with regulations that affect data collection in an electronic format. Collaboration and communication with appropriate team members during all phases of clinical trials will be highlighted. What You’ll Learn: Participants completing the training should be able to accomplish the following objectives: Identify business needs related to implementing an EDC system for a study and/or program Create (or give guidance for implementing) necessary features of an EDC system Understand data specifications unique to EDC Discuss the impact of EDC on existing DM processes and data collection tools Associate the information for full system implementation and documentation This course addresses competencies tested in the CCDM® exam under the EDC domain. Who Should Attend: All CDMs that are investigating the identification, availability and attributes of selecting an EDC system for their company. Participants should be experienced data managers who have in-depth knowledge of the majority of data management and related processes. The course will focus on the foundational components of evaluating and developing the requirements, vendor selection and implementation of EDC systems for clinical trials databases. Once enrolled, participants will need a computer with access to the Internet and the ability to print out course materials. Recommended time commitment is 8-10 hours per week to complete each module. Four modules will be offered; one module per week with discussions, activities and assignments required for each module.