Clinical trials take time and consume a lot of resources, hence, they must be conducted after adequate consideration of the whole process. Structures must be put in place to ensure the consistency of conditions as much as possible since this will greatly reduce errors and make the research findings reliable. This course exposes the basics of clinical trial and data management outlining the goals, tools, and processes involved. If the data obtained from a clinical research exercise is deemed unreliable the purpose is defeated and the resources wasted. You will also learn about the CDISC which is an organization that regulates clinical trial operations to ensure compliance with international standards.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Overview of Good Clinical Practice
Lesson 2: What is Clinical Research and Clinical Trial?
Lesson 3: Types and Phases of Clinical Trials
Lesson 4: Clinical Trial Data Management and Professionals
Lesson 5: What is Clinical Data Management?
Lesson 6: The Roles and Responsibilities in Clinical Data Management
Lesson 7: Clinical Trial Data Validation Plan
Lesson 8: Quality Management in Clinical Trials