Who is considered “vulnerable”? – Answer- 1. prisoners
- med/nursing students
- military
- people in nursing homes
- impoverished/unemployed/homeless
- minors
- ethnic minorities
- people with incurable/terminal illnesses
A participant develops colon cancer (unrelated to study) and is asymptomatic. This is
considered an SAE because colon cancer is life-threatening. True or False? – AnswerFALSE
Who is responsible for designing the protocol?
a) PI
b) Sponsor
c) Institution
d) IRB/IEC – Answer- b) Sponsor
You’re a study manager & one of your monitors reports significant non-compliance at a
site. Which is your first course of action?
a) 2nd opinion monitor visit
b) study report
c) root cause analysis
d) suspension of trial – Answer- c) root cause analysis
If attempts to secure compliance at a site have failed, should sponsor…
a) terminate the site
b) re-train the site & develop a corrective plan – Answer- a) terminate the site
What is “Phase IV” also known as? – Answer- Therapeutic Use
What are ways to minimize the amount of blood drawn and/or number of venipunctures
from pediatric patients? – Answer- -use sensitive assays (to reduce the amt of blood
req.)
-use labs that are used to handling small volumes of blood to perform analyses
-collect routine bloodwork at the same time as PK whenever possible
-indwelling catheters
-sparse sampling
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-modeling adult data for pharmacokinetics
Pharmacokinetic Phase I studies in children are generally conducted in healthy pediatric
subjects. True or False? – Answer- FALSE
What is the name of the assessment used to stage a youth’s pubertal development? –
Answer- Tanner Staging
When is an AE considered an ADR? – Answer- In pre-approved clinical settings - Either a new med product OR existing med product with new usages
- Must be causal relationship
In post-marketed products - noxious & unintended response to a drug that occurs at normal doses
What is an unexpected ADR? – Answer- ADR that is not consistent in nature and/or
severity with IB
What situations require expedited reporting to IRB? – Answer- 1. Any UNEXPECTED
SERIOUS ADR - Increased rate of occurrence of EXPECTED SERIOUS ADR
- Significant hazard to patient population (e.g. lack of efficacy of IP treating a lifethreatening disease)
- Major safety finding from new animal study
Expedited Reporting
When should you report fatal/life-threatening UNEXPECTED ADRs? – Answer- ASAP
(no later than 7 calendar days)
Complete full report no later than 8 days after that
Expedited Reporting
When should you report non-fatal/life-threatening UNEXPECTED ADRs? – AnswerASAP (no later than 15 calendar days)
What data should be included in an expedited report? – Answer- 1. patient info (study #,
DOB, sex, etc.) - suspected med. products (brand, batch #, dosage form, indication, route of admin,
etc.)