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Managing Clinical Trials Utilizing Electronic Data Capture EDC2 2021

Managing Clinical Trials Utilizing Electronic Data Capture (EDC2) NEW DATE: June 14 - July 10, 2021 https://www.pathlms.com/scdm/courses/... Overview The course will address study conduct utilizing Electronic Data Captures (EDC) systems, whether managed directly by a sponsor, with an EDC vendor, or through a Contract Research Organization (CRO). Concepts related to the EDC system, the EDC study application, user roles, responsibilities and training as well as regulatory requirements for change management will be addressed. A sample protocol will provide application of learning to real world situations. Over four weeks, the course will address general principles, best practice and issues that will allow a Data Manager to work collaboratively and communicate effectively with appropriate team members during study conduct. Topics will include user management, training compliance and regulatory considerations for working in an electronic environment. Participants will gain an understanding of necessary Software Development Life Cycle (SDLC) documentation for EDC system updates, as well as mid-study updates for the EDC study application. Considerations for 'faster to lock" will be introduced to take advantage of EDC process. What You'll Learn Participants completing the training should be able to accomplish the following objectives: Define EDC workflow, change management, and documentation unique to EDC Describe best practice for proactively validating data to achieve faster DB Lock Author test scripts needed for Validation and change control Compare criteria for EDC system management verses EDC study management This course addresses competencies tested in the CCDM® exam under the EDC domain. Intended Audience CDMs and others involved in study conduct that will be or are currently responsible for conducting clinical trials utilizing EDC. 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 managing clinical trials utilizing EDC. 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 (1 module = 1 week)