Introduction to Clinical Trial Protocols

Clinical trial protocols

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Clinical trials take time and consume a lot of resources, hence, they must be conducted after adequate consideration of the whole process. We must put structures 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 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


  • 13 Principles of GCP


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


  • What is Clinical Trial Management?
  • What is a Clinical Trial Management System (CTMS)?
  • How to Compare Clinical Data Management Systems


Lesson 5: What is Clinical Data Management?


  • Model for Data Management in Clinical Trials
  • Clinical Research Data Areas of Responsibility


Lesson 6: The Roles and Responsibilities in Clinical Data Management


  • What is Clinical Trial Data Management (CDM)?
  • Clinical Data Management Plans


Lesson 7: Clinical Trial Data Validation Plan


  • Data Management Workflow
  • Clinical Trial Data Audits


Lesson 8: Quality Management in Clinical Trials


  • Regulations, Guidelines, and Standards in Clinical Data Management
  • Case Report Forms in Data Management
  • Introduction to Electronic Clinical Trial Management Systems
  • The Business Need for CTMSs
  • Basic Structure, Contents, and Functioning of CTMS
  • Electronic System Requirements
  • Outputs






Ellena Jefferson
Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.


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