The Process & Phases
What is the first step in starting a clinical trial?
Designing the research protocol
What is the purpose of an informed consent form?
To ensure participants understand the study and agree voluntarily
What is the "research question"?
The specific question the study is trying to answer
How many main phases are there in a drug clinical trial?
Four
Who reviews studies to ensure they are ehical before they start?
The IRB or Ethics Committee
What does "eligibility criteria" mean?
The rules for who can or cannot join the study
What is the main goal of a Phase 1 trial?
To assess safety and dosage
True or False: Participants can withdraw from a study at any time without penalty
True
Name an example of an intervention in a clinical trial
Answers may vary (a drug, therapy, medical device, etc)
What happens in Phase 3 of a clinical trial?
Testing effectiveness on large groups, monitoring side effects
What are five things that in an informed consent form?
Answers may vary
What is the purpose of a data collection plan?
To explain how and when study data will be gathered and recorded
Name the steps in the clinical research process in order (get most of them)
Research question -> Protocol design -> Ethics approval -> Recruitment -> Consent -> Intervention -> Data collection -> Analysis -> Publication
A participant doesn't speak the local language. What shold you do to ensure valid consent?
Use a translated consent form and/or qualified interpreter
List 5 elements that should be included in a full research protocol
background, objectives, risks, intervention, eligibility, informed consent, procedures, data collection, references
(any three)