Certified Clinical Research Study Flashcards

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

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.

When a CRA discovers that an investigator site has been enrolling subjects before IRB approval was obtained, what is the FIRST action to take?

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.

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?

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.

Under ICH E6(R2), what is the minimum content required in a monitoring visit report?

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.

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?

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.

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)?

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.

What is the purpose of an Investigator Brochure (IB) in a clinical trial?

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.