Introduction to Clinical Trial Protocol & Design

It is crucial to examine and critically assess the study's results using a well-written clinical trial protocol and a well-defined clinical trial design in which the entire clinical trial process is succinctly summarized. A series of protocols or actions that must be taken in order to complete the clinical study are outlined in this module. The significance of comprehending the procedures involved in creating a clinical research/clinical trial protocol is highlighted in this session as a means of conducting a suitable study and producing accurate findings.

Course Description

A well written protocol and a well-defined trial design are essential to review and critically evaluates the outcome of the trial. It gives a concise overview of the project. The Advanced Concepts in Clinical Research Level 4 module defines a set of procedures or steps to be followed for the accomplishment of the clinical study. This module brings forth the importance of understanding the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results.

Who should apply?

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
  • Graduate or equivalent degree in Nursing/Allied Health.
  • Students in their final year of graduation for the above courses may also apply.

What you will learn in this course

This program will help the life science and health science graduates to learn about the required set of procedures for a clinical study, significance of maintaining a clinical research protocol and learn how a protocol contributes to the concise overview of any project.

Structure of Course Delivery

Clinical research courses will be made available online. It consists of several in-depth lectures delivered by a subject matter expert, appropriately supported by slides, images, and interactive materials where necessary. The delivery has a tremendous degree of versatility. A class may be paused to allow you to take notes and refer to your textbooks (not provided). If you already know a certain part of the lecture, you can rewind it to hear it again or skip a slide or two. You are free to go back over a section at a later time if you need to review it before your assessment. You are free to take the topics in this course in whatever order you choose, even though our curriculum may prescribe otherwise. Clinical data management course, clinical research training, medical research courses, etc are few popular courses by True Lessons.


Many of our students felt that the way the clinical trial courses are taught has made it easier for them to keep up with the intense lectures in real class— it's like having a TV remote in class to self-pace your teacher.

Visuals in the presentations aid in better comprehension by making topics easier to learn... and more difficult to forget!


team images
Ms Amrutha Babu
Academic Mentor

Ms. Amrutha is an accomplished academic expert in the field of Food and Nutrition. She has a Master’s degree from Mahatma Gandhi University, Kottayam where she graduated with a gold medal. After undergoing training in Christian Medical College, Vellore started her career as a freelance diet counselor in 2009. She was also associated with Lybrate - an online platform for diet management and counseling.

After a remarkable experience in the field of dietetics, she received a post-graduate diploma in Clinical Research. Currently, she is associated with TrueLessons as an academic mentor. Her core strengths are providing excellent teaching and guidance to her students. Amrutha has more than 7 years of teaching experience in the field of clinical research. She has in-depth knowledge about Drug Discovery Process, Drug Approval process, Trial documents, Trial Design, Regulatory Affairs, Query writing, ICSR, and so on.

This program will provide the students with an opportunity to work with various MNCs.

Students can get engaged in different profiles like

  • Clinical Research Coordinator
  • Clinical Research Associate
  • Scientific Document Reviewer
  • Quality Control
  • Quality Analyst
  • Regulatory Associate
  • Regulatory Specialist
  • Investigators and Sub-investigators


  • Duration 5 hours
  • Chapters 5
  • Skill Level Beginner
  • Language English
  • Instructor Dr Divya Sunil
  • Instructor Ms Amrutha Babu
  • Instructor Dr Smitha Seshagiri