CCRA Certified Clinical Research Study 2 — Questions and Answers
Question 1: Which document serves as the primary agreement between a sponsor and an investigator outlining responsibilities and financial terms for a clinical trial?
- Clinical Trial Agreement (CTA) (Correct answer)
- Informed Consent Form (ICF)
- Investigator Brochure (IB)
- Protocol Amendment
Correct answer: Clinical Trial Agreement (CTA)
The Clinical Trial Agreement (CTA) is the legally binding contract between the sponsor and investigator/institution covering obligations, liabilities, and financial terms.
Question 2: When a CRA discovers that an investigator site has been enrolling subjects before IRB approval was obtained, what is the FIRST action to take?
- Place the site on clinical hold immediately
- Document the finding and notify the sponsor promptly (Correct answer)
- Terminate the site's participation in the trial
- Retrain the site staff on GCP requirements
Correct answer: Document the finding and notify the sponsor promptly
The CRA must document the protocol deviation and notify the sponsor promptly so that corrective actions can be evaluated and regulatory obligations met.
Question 3: A source document verification (SDV) check reveals that a subject's weight recorded in the eCRF differs from the medical chart. What should the CRA do?
- Correct the eCRF entry directly
- Request the investigator or designee issue a data query to reconcile the discrepancy (Correct answer)
- Accept the eCRF value as the official record
- Notify the IRB of the data discrepancy
Correct answer: Request the investigator or designee issue a data query to reconcile the discrepancy
The CRA should raise a data query so that authorized site personnel can review source documents and correct the eCRF with appropriate audit trail documentation.
Question 4: Under ICH E6(R2), what is the minimum content required in a monitoring visit report?
- Enrollment numbers only
- Date of visit, site visited, CRA name, findings, deviations, and follow-up actions (Correct answer)
- Protocol version and IRB approval number
- List of all subjects enrolled and their randomization codes
Correct answer: Date of visit, site visited, CRA name, findings, deviations, and follow-up actions
ICH E6(R2) requires monitoring reports to capture the visit date, site, monitor identity, findings, deviations, and any required follow-up actions.
Question 5: Which regulatory requirement mandates that clinical trial records must be retained for a minimum of 2 years after the last approval of a marketing application, or 2 years after the investigation is discontinued?
- 21 CFR Part 312.62 (Correct answer)
- 21 CFR Part 50.25
- 21 CFR Part 56.115
- 21 CFR Part 11.10
Correct answer: 21 CFR Part 312.62
21 CFR 312.62 specifies investigator record retention requirements for IND studies, including the 2-year minimum retention period.
Question 6: A subject experiences a Serious Adverse Event (SAE) on a Monday. Within what timeframe must the investigator report an unexpected, fatal SAE to the sponsor under ICH E6(R2)?
- Within 7 calendar days (Correct answer)
- Within 15 business days
- Within 24 hours
- Within 30 calendar days
Correct answer: Within 7 calendar days
ICH E6(R2) requires investigators to report fatal or life-threatening unexpected SAEs to the sponsor within 7 calendar days of first awareness.
Question 7: What is the purpose of an Investigator Brochure (IB) in a clinical trial?
- To obtain regulatory approval to conduct the trial
- To provide investigators with clinical and nonclinical data about the investigational product (Correct answer)
- To document the subject's consent to participate
- To outline the statistical analysis plan for the study
Correct answer: To provide investigators with clinical and nonclinical data about the investigational product
The IB compiles relevant preclinical and clinical information about an investigational product to guide investigators in safely conducting the trial.
CCRA Certified Clinical Research Study 2
Which document serves as the primary agreement between a sponsor and an investigator outlining responsibilities and financial terms for a clinical trial?