Randomization & Blinding in Clinical Research Trials

5/5
47
randomization clinical trial

Duration :

2

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

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.

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 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

 

Glossary

 

Conclusion

 

Quiz

Author:

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.

Reviews:

5/5
47
USD: United States (US) dollar ($) ^

$60

Buy now

More than 25 learners ? Request a quote !

This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

[finale_countdown_timer campaign_id="40465" skip_rules= "yes"]

$60.00

$60.00

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course