CCRA Certified Clinical Research Study 2

Question 1

Which document serves as the primary agreement between a sponsor and an investigator outlining responsibilities and financial terms for a clinical trial?

Accepted Answer

Clinical Trial Agreement (CTA)

Answer

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?

Accepted Answer

Document the finding and notify the sponsor promptly

Answer

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?

Accepted Answer

Request the investigator or designee issue a data query to reconcile the discrepancy

Answer

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?

Accepted Answer

Date of visit, site visited, CRA name, findings, deviations, and follow-up actions

Answer

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?

Accepted Answer

21 CFR Part 312.62

Answer

21 CFR 312.62 specifies investigator record retention requirements for IND studies, including the 2-year minimum retention period.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Certified Clinical Research Study 2