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? - 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

 1 / 2

-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 lifethreatening 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? - AnswerASAP (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.)