Regulatory Compliance and GCP Flashcards

In the context of 21 CFR Part 11, what is a 'closed system'?

Answer: An environment where access is controlled by persons responsible for the electronic records

A closed system under 21 CFR Part 11 is one where system access is controlled by the organization responsible for the electronic records stored within it.

What is a 'serious adverse event' (SAE) as defined under ICH E2A?

Answer: Any event resulting in death, hospitalization, disability, congenital anomaly, or life-threatening situation

ICH E2A defines an SAE as any adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or results in congenital anomaly.

Which GCP principle states that clinical trial records must be retained for a defined period after trial completion?

Answer: Essential document archiving requirements under ICH E6

ICH E6 requires that essential documents be archived for a minimum defined period (typically 2 years after the last marketing approval or 2 years after discontinuation) to support regulatory review.

What is the primary goal of source data verification (SDV) in clinical trial monitoring?

Answer: To confirm that CRF data accurately reflects source documents at the investigational site

SDV involves a monitor comparing CRF entries directly to source documents at the site to verify data accuracy, completeness, and consistency with the protocol.

Under HIPAA, what is a 'limited data set' in the context of clinical research?

Answer: Protected health information with certain direct identifiers removed but still including dates and geographic data

A HIPAA limited data set has direct identifiers removed but may retain indirect identifiers like dates and geographic subdivisions, and requires a data use agreement.

What is the significance of a 'certificate of compliance' issued after a regulatory inspection of a clinical trial site?

Answer: It indicates the inspector found no objectionable conditions at the site

A certificate of compliance (Form FDA 483 with no findings or a subsequent EIR with no action indicated) means the inspection found the site in compliance with applicable regulations.