CCRA Certified Clinical Research Associate 5

Question 1

Under the ALCOA principles for data integrity in clinical trials, what does the 'A' stand for and why is it critical?

Accepted Answer

Accurate — data must reflect the true value measured, ensuring trial results are reliable

Answer

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate; 'Accurate' ensures recorded data reflects the true measurement, which is foundational to valid trial results.

Question 2

A sponsor wishes to implement a protocol amendment that changes the primary endpoint. Which regulatory body must approve this amendment before it can be implemented at US sites?

Accepted Answer

Both the FDA (via IND amendment) and the IRB

Answer

Significant protocol changes must be submitted to the FDA as an IND amendment and approved by the site's IRB before implementation.

Question 3

During a pre-study site evaluation visit, the CRA assesses several factors. Which finding would most likely lead the sponsor to REJECT a site?

Accepted Answer

The site lacks sufficient staff and patient population to meet enrollment targets

Answer

Insufficient patient population or staffing capacity directly threatens the feasibility of completing the trial and is grounds for not selecting a site.

Question 4

What is the definition of 'source data' according to ICH E6(R2)?

Accepted Answer

Original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial

Answer

Source data includes all original records (e.g., hospital records, lab printouts, diaries) and certified copies that document clinical trial activities.

Question 5

An investigator at a US site is found to have a significant financial interest in the sponsor company. According to 21 CFR Part 54, the sponsor must:

Accepted Answer

Disclose the financial interest to the FDA in the marketing application

Answer

21 CFR Part 54 requires sponsors to disclose investigators' significant financial interests to the FDA as part of the marketing application so regulators can assess potential bias.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Certified Clinical Research Associate 5