Certified Clinical Research Associate Flashcards

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

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

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

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?

Answer: Both the FDA (via IND amendment) and the IRB

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

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

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

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

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

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

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

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:

Answer: Disclose the financial interest to the FDA in the marketing application

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.

A CRA performs a remote/centralized monitoring review and notices an unusual clustering of perfect protocol adherence at one site compared to all others. What should this trigger?

Answer: A data integrity investigation and possible for-cause monitoring visit to rule out data fabrication

Statistically improbable patterns such as perfect adherence are a red flag for potential data fabrication and warrant a targeted for-cause visit and data integrity investigation.

Which of the following best describes the sponsor's obligation under GCP if a clinical trial is prematurely terminated?

Answer: The sponsor must promptly notify investigators and regulatory authorities, ensure subject safety follow-up, and retain all records per applicable requirements

Upon premature termination, the sponsor must notify all investigators and relevant regulatory authorities, arrange for subject safety follow-up, and ensure proper record retention.