Certified Clinical Research Associate Flashcards

What is the key difference between an adverse event (AE) and an adverse drug reaction (ADR) in clinical trial terminology?

Answer: An ADR implies a causal relationship to the investigational product, whereas an AE does not require causality

An ADR requires at least a reasonable possibility of a causal relationship to the study drug, while an AE is any untoward medical occurrence regardless of causality.

During source data verification (SDV), the CRA finds that a lab value in the CRF was changed without documentation. What does this indicate?

Answer: A potential data integrity issue that must be queried and documented

Undocumented CRF changes violate ALCOA+ data integrity principles and must be investigated, queried, and documented in the monitoring report.

Which regulatory document grants the FDA authority to inspect clinical investigators conducting trials under an IND?

Answer: 21 CFR Part 312 — IND Regulations

21 CFR Part 312 establishes IND requirements and grants FDA the authority to inspect clinical investigators and their records.

A site coordinator asks a CRA if she can enter data into the CRF on behalf of the investigator to save time. What should the CRA advise?

Answer: Site staff may enter data if authorized and trained, but the investigator must review and sign off on all entries per protocol

Sub-investigators and coordinators may enter CRF data if authorized by the investigator and documented on the site's delegation log, with the investigator retaining oversight responsibility.

What is the primary purpose of the Investigator's Brochure (IB)?

Answer: To compile and summarize clinical and nonclinical data relevant to the investigational product for investigators

The IB compiles all relevant preclinical and clinical information about the investigational product to inform investigators about risks, properties, and safe use.

A subject reports a new, unexpected, drug-related serious adverse event. According to ICH E6, within what timeframe must the investigator report this to the sponsor?

Answer: Within 24 hours of becoming aware

ICH E6(R2) requires investigators to report all serious adverse events to the sponsor immediately, and no later than 24 hours of their becoming aware of the event.

What is the role of a Central IRB (cIRB) in a multi-site clinical trial?

Answer: To provide a single ethics review that can cover multiple sites, streamlining oversight

A central IRB conducts a single ethics review applicable to multiple participating sites, reducing duplication and streamlining the approval process.