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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions:

1. Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?

A) 400 mg/m²
B) 444 mg/m²
C) 492 mg/m²
D) 420 mg/m²

2. According to ICH GCP, sponsor-specific essential documents must be retained until:

A) 2 years after last approval and no pending applications
B) 25 years after last approval
C) 5 years after last approval
D) 3 years after last approval

3. An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?

A) Research pharmacist
B) OHRP
C) FDA
D) Sponsor

4. Which of the following identifies content that should be included in a clinical research protocol?

A) Criteria for the selection of an investigator
B) A summary of findings of nonclinical studies that potentially have clinical significance
C) Standard operating procedures for data collection
D) IRB/IEC approval and meeting minutes

5. In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

A) Written information to be provided to the subjects
B) IRB/IEC requirements for reporting to the regulatory authority
C) Requirements for storage of the investigational product
D) Sponsor's SOPs

Solutions: