CCRA Certified Clinical Research Associate 5 — Questions and Answers
Question 1: Under the ALCOA principles for data integrity in clinical trials, what does the 'A' stand for and why is it critical?
- Accurate — data must reflect the true value measured, ensuring trial results are reliable (Correct answer)
- Anonymous — subject identifiers must be removed from all records
- Automated — electronic systems must generate all entries
- Audited — every record must be independently verified by the CRA
Correct 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.
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?
- The FDA only
- The IRB only
- Both the FDA (via IND amendment) and the IRB (Correct answer)
- The DSMB and the sponsor's medical monitor
Correct 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.
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?
- The site has conducted only two prior clinical trials
- The investigator's delegation log is not yet prepared
- The site lacks sufficient staff and patient population to meet enrollment targets (Correct answer)
- The site's pharmacy stores investigational product in a separate area
Correct 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.
Question 4: What is the definition of 'source data' according to ICH E6(R2)?
- Data entered directly into the electronic CRF by the site coordinator
- Original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial (Correct answer)
- Data that has been verified and approved by the sponsor's data management team
- Randomization codes held by the unblinded statistician
Correct 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.
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:
- Immediately remove the investigator from the trial
- Disclose the financial interest to the FDA in the marketing application (Correct answer)
- Obtain IRB approval to allow the investigator to continue
- Require the investigator to divest all financial interests before enrollment begins
Correct 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.
Question 6: 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?
- Recognition of the site as a top performer and reduction of monitoring visits
- A data integrity investigation and possible for-cause monitoring visit to rule out data fabrication (Correct answer)
- Immediate database lock for that site's data
- Notification to the IRB that the site can enroll additional subjects
Correct 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.
Question 7: Which of the following best describes the sponsor's obligation under GCP if a clinical trial is prematurely terminated?
- The sponsor may archive all records immediately and close all sites within 30 days
- The sponsor must promptly notify investigators and regulatory authorities, ensure subject safety follow-up, and retain all records per applicable requirements (Correct answer)
- The sponsor only needs to notify the FDA; investigator notification is optional
- Premature termination requires no special action if fewer than 50 subjects were enrolled
Correct 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.
CCRA Certified Clinical Research Associate 5
Under the ALCOA principles for data integrity in clinical trials, what does the 'A' stand for and why is it critical?