RAC Clinical Trials and GCP 5

Question 1

Which ICH guideline specifically addresses the statistical principles for clinical trials, including randomization and blinding?

Accepted Answer

ICH E9

Answer

ICH E9 provides guidance on statistical principles for clinical trials, covering randomization, blinding, analysis populations, and handling of missing data.

Question 2

A sponsor-monitor identifies during a routine visit that the investigator has been enrolling subjects who do not meet the age inclusion criterion. The monitor's FIRST step should be:

Accepted Answer

Document the finding and discuss with the investigator to implement corrective action

Answer

The monitor should document the eligibility deviation and work with the investigator to implement a corrective and preventive action (CAPA) plan.

Question 3

Under 21 CFR 56.114, multi-site studies may use a single IRB (sIRB) arrangement. This became mandatory for domestic cooperative research under:

Accepted Answer

NIH Policy effective January 25, 2018

Answer

The revised NIH Policy on the Use of a Single Institutional Review Board mandated sIRB review for NIH-funded multi-site domestic studies effective January 25, 2018.

Question 4

What is the purpose of a 'washout period' in a crossover clinical trial design?

Accepted Answer

To eliminate residual effects of the first treatment before administering the second

Answer

A washout period is included between treatment periods in crossover designs to eliminate carryover effects from the preceding treatment.

Question 5

Under GCP, a Certificate of Analysis (CoA) for an investigational drug product must be retained by the:

Accepted Answer

Investigator at the site as part of the investigator site file

Answer

The CoA for investigational product must be maintained in the investigator site file (Trial Master File) per ICH E6 essential documents requirements.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Clinical Trials and GCP 5