Who is considered "vulnerable"? - Answer- 1. prisoners
2. med/nursing students
3. military
4. people in nursing homes
5. impoverished/unemployed/homeless
6. minors
7. ethnic minorities
8. people with incurable/terminal illnesses
A participant develops colon cancer (unrelated to study) and...
ACRP CCRA EXAM QUESTIONS AND ANSWERS
Who is considered "vulnerable"? - Answer- 1. prisoners
2. med/nursing students
3. military
4. people in nursing homes
5. impoverished/unemployed/homeless
6. minors
7. ethnic minorities
8. 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? - Answer- FALSE
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 -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
1. Either a new med product OR existing med product with new usages
2. Must be causal relationship
In post-marketed products
1. 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
2. Increased rate of occurrence of EXPECTED SERIOUS ADR
3. Significant hazard to patient population (e.g. lack of efficacy of IP treating a life-
threatening disease)
4. 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? - Answer- ASAP (no later than 15 calendar days)
What data should be included in an expedited report? - Answer- 1. patient info (study #, DOB, sex, etc.)
2. suspected med. products (brand, batch #, dosage form, indication, route of admin, etc.)
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