GXP2390 Randomization Process and Unblinding for Analysis

GXP2390 Randomization Process and Unblinding for Analysis

Description:

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.

 

 

Curriculum

 

Introduction

 

Lesson 1: Randomization – 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

 

Glossary

 

Conclusion

 

Quiz

Author:

GXP2390 Randomization Process and Unblinding for Analysis
Swati Pund
Swati Pund holds a Doctorate in Pharmaceutical Sciences with post-doctoral research experience in nanomedicine at IIT-Bombay, India. She has more than 20 years of experience in the academic, pharma industry, and pharmaceutical research laboratories. Her expertise includes Conventional and nano-delivery systems of drugs and nutraceuticals,Targeted drug delivery systems, Optimization of formulation and process using QbD, Biopharmaceutics and pharmacokinetic analysis, and Mammalian cell culture techniques. Animal model development Swati is a Co-Founder of Biobay (www.biobaysolutions.com), and her main activity is Pharmaceutical Consultancy and Scientific Communications.

General info:

Duration:

1 hour

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

Very helpful introduction to randomization and unblinding. The team now has a better understanding of how bias is excluded in clinical trials.

Alex S.

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Chief Operations Officer

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GXP2390 Randomization Process and Unblinding for Analysis

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