International Psoriasis Council

Chapters

Opening
Introduction
Chapter 1
The Evolution of the Clinical Trials Process - A Brief History Lesson
Chapter 2
It Takes a Village to Conduct a Clinical Trial
Chapter 3
Not All Clinical Trials are Created Equal - Understanding the Different Phases
Chapter 4
There's No Going Outside the Lines - Ethical Considerations in the Conduct of Clinical Trials
Chapter 5
What You Need to Know to Live in Harmony with Your Institutional Review Board and Research Ethics Committee

Chapter 6
Be Informed About Informed Consent
Chapter 7
Practical Advice for Following Good Clinical Practice
Chapter 8
Living in a Material World - What is Needed to Run a Successful Clinical Trial
Chapter 9
Clinical Trial Coordinators - A Vital Sign of a Good Clinical Trial
Chapter 10
The Subject of Recruitment and Retention
Chapter 11
The Investigational Compound - Like Handling Kryptonite
Chapter 12
Budgets and Contracts - Show Me the Money
Chapter 13
Everything You Write Can Be Used Against You in a Court of Law - Understanding Proper Documentation
Chapter 14
Audits/Inspections - Be Prepared for Anything
Chapter 15
Conducting Clinical Trials Without Ending Up on Trial

IRB

Complete the post-test online at www.cmeuniversity.com. On the navigation menu, click on "Find Post-tests by Course" and search by project ID 4962. Upon registering and successfully completing the post-test with a score of 70% or better and the evaluation, your certificate will be made available immediately. At this time, you will also have the opportunity to download a pdf of the post-test answer rationales.

Quiz

You are interested in participating in a research study and want to understand the process at your IRB, but you are not sure what IRB stands for because you can’t find it in your hospital directory. Which of the following is what IRB abbreviates?

a) Internal Review Board

b) International Review Board

c) Institutional Review Board

d) None of the above

You’ve recently moved from the United Kingdom to Sweden. Is the ethics review process of the Swedish REC the same as you experienced with the REC you worked with in the United Kingdom?

a) Yes

b) No

You are preparing a submission package for a study of a new breast cancer drug for review by your IRB. It is taking you longer than you expected to write the protocol because the research is complicated. You think about just submitting it as it is but decide to spend more time explaining the research because of which of the following?

a) It is important for the IRB to understand the rationale of the study, not just how the subjects will be processed

b) The IRB consists of cardiologists and not oncologists

c) The IRB has a lay person member

d) All of the above

You are submitting for approval a follow-up study to one that was completed 2 years ago. You ask your REC if they still have the materials for the original study because you want to base the new submission on the previous one. The ICH GCP Guidelines state that IRB/RECs should retain all relevant records for at least how many years after the completion of the trial?

a) 1 year

b) 3 years

c) 5 years

d) 7 years

A pharmaceutical company has approached you about participating in a new study. Who should contact the IRB/REC?

a) You

b) Study sponsor