SCDM Regulatory Compliance and GCP 3

Question 1

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

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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

Accepted Answer

Essential document archiving requirements under ICH E6

Answer

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.

Question 4

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

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

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

Answer

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.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Regulatory Compliance and GCP 3