Clinical Trials and GCP Flashcards

Under 21 CFR Part 312, what is the maximum period an IND may remain on clinical hold before the FDA must provide written explanation?

Answer: 30 days

FDA must notify the sponsor in writing of a clinical hold within 30 days of receiving the IND or amendment.

Which GCP principle requires that the benefit-to-risk ratio be favorable before a clinical trial begins?

Answer: Beneficence and non-maleficence

Beneficence (do good) and non-maleficence (avoid harm) together require a favorable benefit-risk assessment prior to trial initiation.

A sponsor receives an SAE report from an investigator on a Saturday. Under 21 CFR 312.32, fatal unexpected SUSARs must be reported to FDA within:

Answer: 7 calendar days

Fatal or life-threatening unexpected serious adverse drug reactions must be reported to the FDA within 7 calendar days.

What term describes the process by which an IRB reviews a study where the only involvement is a minimal-risk survey of adults?

Answer: Exempt determination

Research involving minimal risk with anonymous surveys of adults may qualify as exempt from IRB oversight under 45 CFR 46.104.

Which document establishes the formal agreement between a sponsor and a CRO, transferring specific IND obligations?

Answer: Written transfer agreement per 21 CFR 312.52

21 CFR 312.52 requires a written agreement specifying which IND obligations have been transferred from sponsor to CRO.

In GCP, source documents are BEST described as:

Answer: Original records or certified copies from which CRF data are derived

Source documents are original records (e.g., hospital charts, lab reports) or certified copies that serve as the basis for CRF entries.

When a protocol deviation occurs at a site, the investigator's PRIMARY obligation is to:

Answer: Document and report the deviation per protocol and IRB requirements

Investigators must document protocol deviations and report them according to the protocol requirements and IRB policies.