Randomization & Blinding in Clinical Research Trials

randomization clinical trial

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through ourย certificate online checker. They can also be shared on Linkedin.


Clinical trials are literal information factories and the data obtained from them must be accurate, reproducible, and generalizable to the population being studied. Hence, researchers know to exclude bias as much as possible. Randomization and Blinding are two tools that help to make a study more credible. Randomization puts subjects into test groups randomly and Blinding prevents a set of participants in the study from identifying which subjects are on which treatments.

This course introduces participants to these concepts and walks them through the types and how to use them. You will also learn about unblinding, which is the opposite of blinding and is used to provide insight into the clinical efficacy of an investigational drug.


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: Randomization โ€“ Definition and Importance


  • What is Randomization?
  • Why is it Necessary?
  • Is It Ethical?
  • Randomization Techniques


Lesson 2: Randomization Techniques: Simple Randomization & Unequal Allocation


  • Simple Randomization
  • Unequal Allocation


Lesson 3: Randomization Techniques: Block & Stratification


  • Block Randomization
  • Stratified Randomization


Lesson 4: Adaptive Randomization Technique


  • What is Adaptive Randomization?
  • Minimization
  • Response-adaptive Randomization


Lesson 5: Blinding


  • What is Blinding?
  • Why is it Necessary?
  • Types of Blinding


Lesson 6: Unblinding

  • What is Unblinding?
  • Unblinding for Analysis
  • Documentation








patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards.


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