CTA Good Clinical Practice & ICH Guidelines 3

Question 1

ICH E6(R2) requires that informed consent be obtained before which of the following?

Accepted Answer

Before any trial-specific procedures are performed

Answer

GCP mandates that informed consent must be obtained prior to any trial-specific screening or treatment procedures being conducted.

Question 2

Which ICH guideline provides guidance on statistical principles for clinical trials, including randomization and blinding?

Accepted Answer

ICH E9

Answer

ICH E9 — 'Statistical Principles for Clinical Trials' — covers randomization, blinding, analysis populations, and handling of missing data.

Question 3

In the context of ICH E6(R2), 'source data' is defined as:

Accepted Answer

All information in original records and certified copies of original records

Answer

Source data includes all original records (paper or electronic) and certified copies that contain clinical trial information.

Question 4

Under GCP, what action must an investigator take when a protocol deviation that may affect subject safety occurs?

Accepted Answer

Report it promptly to the sponsor, IRB/IEC, and regulatory authority as required

Answer

Protocol deviations affecting subject safety must be promptly reported to the sponsor, IRB/IEC, and regulatory authorities according to applicable requirements.

Question 5

Which ICH guideline establishes the general considerations for clinical development planning, including dose-finding and early phase studies?

Accepted Answer

ICH E8

Answer

ICH E8 — 'General Considerations for Clinical Trials' — outlines the overall development framework including early phase, dose-finding, and confirmatory trials.

(CTA) Clinical Trial Associate Certification Practice Test

(CTA) Clinical Trial Associate Certification Practice Test

CTA Good Clinical Practice & ICH Guidelines 3