Clinical trial management is the process of planning, overseeing, and executing clinical trials. It’s important to ensure that trials are conducted safely and result in findings that advance medical research.
Curriculum
- 5 Sections
- 22 Lessons
- 12 Weeks
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- Module 1: Introduction to Clinical Trials (Week 1-2)4
- Module 2: Ethical & Regulatory Aspects (Week 3-6)4
- Module 3: Clinical Trial Protocol & Study Design (Week 7-10)4
- Module 4: Project Management (Week 11-14)- 8 hours5
- 4.1Project Initiation, Planning and Execution
- 4.2Monitoring, closing and focusing on communication
- 4.3Role of Project Management Specialists and Clinical Research Associates (CRAs)
- 4.4Stakeholders approach for successful adoption of projects.
- 4.5Hands-on: To Manage the projects from start to end and CTMS skills.
- Module 5: Records Information Management-Electronic Trial Master File (eTMF) (Week 15-18)- 9 hours5
- 5.1Essential Documents (E6 Guidelines) in Clinical Research
- 5.2Documents Workflow process and databases used to manage eTMF.
- 5.3Documents Identification, collection and quality parameters (ALCOA).
- 5.4DIA eTMF reference Model, Milestones, Inspection readiness for the clinical Trial studies.
- 5.5Hands-on: Applying and managing metadata to the clinical trial documents using TMF Index in different eTMF databases.
