CCRA Introduction to Certified Clinical Research Associate 2 — Questions and Answers
Question 1: Which organization administers the CCRA certification examination in the United States?
- The Association of Clinical Research Professionals (ACRP) (Correct answer)
- The Society of Clinical Research Associates (SoCRA)
- The FDA Office of Clinical Research
- The National Institutes of Health (NIH)
Correct answer: The Association of Clinical Research Professionals (ACRP)
ACRP (Association of Clinical Research Professionals) administers the CCRA certification exam and sets the competency standards for clinical research associates.
Question 2: A CRA notices that a site has been enrolling subjects without obtaining updated ICF signatures after a protocol amendment. What is the CRA's immediate obligation?
- Document the finding as a protocol deviation and report it to the sponsor (Correct answer)
- Halt the trial immediately without notifying anyone
- Re-consent all affected subjects personally without sponsor notification
- Ignore it if no serious adverse events have occurred
Correct answer: Document the finding as a protocol deviation and report it to the sponsor
Failure to obtain updated consent after an amendment is a protocol deviation that must be documented and reported to the sponsor per GCP guidelines.
Question 3: What does the term 'source document verification (SDV)' refer to in clinical monitoring?
- Comparing CRF data to original source documents to confirm accuracy (Correct answer)
- Creating electronic copies of paper records
- Verifying the identity of the investigator at the site
- Checking that the protocol has been approved by the IRB
Correct answer: Comparing CRF data to original source documents to confirm accuracy
SDV is the process of comparing data recorded in the CRF against original source documents to ensure data accuracy and integrity.
Question 4: Under 21 CFR Part 312, an Investigational New Drug (IND) application must be submitted to the FDA before:
- Initiating a clinical investigation of a new drug in humans (Correct answer)
- Publishing preclinical study results
- Applying for NDA approval
- Conducting Phase IV post-marketing studies
Correct answer: Initiating a clinical investigation of a new drug in humans
An IND must be in effect before a sponsor ships an investigational drug across state lines or begins clinical studies in humans.
Question 5: Which ICH E6(R2) principle states that clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification?
- Data integrity (Correct answer)
- Subject confidentiality
- Investigator qualification
- Risk-based monitoring
Correct answer: Data integrity
ICH E6(R2) emphasizes that all clinical trial data must be handled and stored to allow accurate reporting, interpretation, and verification.
Question 6: What is the primary purpose of a Clinical Study Report (CSR)?
- To provide a comprehensive integrated summary of the methods and results of a clinical trial (Correct answer)
- To inform site staff about protocol changes
- To request IRB approval for a new trial
- To document adverse events as they occur during the trial
Correct answer: To provide a comprehensive integrated summary of the methods and results of a clinical trial
A CSR is a comprehensive document integrating clinical and statistical descriptions and analyses of results, required for regulatory submissions.
Question 7: In risk-based monitoring (RBM), which factor is typically used to prioritize monitoring resources?
- The criticality of data and processes to subject safety and data integrity (Correct answer)
- The geographic location of clinical sites
- The number of publications the principal investigator has authored
- The sponsor's quarterly revenue targets
Correct answer: The criticality of data and processes to subject safety and data integrity
RBM prioritizes monitoring efforts based on the risk to subject safety and data integrity, focusing resources where they will have the greatest impact.
CCRA Introduction to Certified Clinical Research Associate 2
Which organization administers the CCRA certification examination in the United States?