SOCRA CCRP Data Management

Question 1

What does 21 CFR Part 11 govern in clinical research?

Accepted Answer

Electronic records and electronic signatures

Answer

IRB review procedures

Answer

Investigational drug labeling

Answer

Adverse event reporting timelines

Question 2

What is the 'audit trail' requirement under 21 CFR Part 11?

Accepted Answer

A computer-generated, time-stamped record of who created, modified, or deleted electronic data

Answer

A financial record of trial expenses

Answer

A log of all adverse events

Answer

A record of all subject visits

Question 3

In clinical data management, what does 'source data' refer to?

Accepted Answer

Original information in original records and certified copies used as the basis of a clinical trial

Answer

Data entered into the sponsor's database

Answer

Data generated by the CRO

Answer

Summarized data in the final study report

Question 4

What is a 'data query' in clinical trial data management?

Accepted Answer

A question raised to resolve a discrepancy or missing data in the case report form

Answer

A request to enroll additional subjects

Answer

A sponsor's request for interim analysis

Answer

A regulatory agency inquiry about the study

Question 5

Which principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?

Accepted Answer

ALCOA principle

Answer

SMART principle

Answer

CDISC standard

Answer

GLP principle

Question 6

What is an eCRF in clinical research?

Accepted Answer

An electronic case report form used to collect study data

Answer

An electronic clinical research file

Answer

An electronic conflict-of-interest reporting form

Answer

An electronic compliance review form