SOCRA CCRP Data Management 3

Question 1

What is the purpose of a trial master file (TMF)?

Accepted Answer

To maintain the essential documents that allow reconstruction and evaluation of the trial conduct

Answer

To store patient medical histories

Answer

To file FDA submission documents only

Answer

To track site budget and payments

Question 2

What does 'data reconciliation' involve in clinical trials?

Accepted Answer

Resolving discrepancies between different databases such as CRF data and safety databases

Answer

Reconciling the trial budget with actual expenses

Answer

Matching subject consent forms to enrollment logs

Answer

Comparing site-level data to national averages

Question 3

Which CDISC standard is used for formatting clinical trial data for FDA regulatory submission?

Accepted Answer

SDTM

Answer

CDASH

Answer

ADaM

Answer

CDISC ODM

Question 4

In clinical data management, what is an 'edit check'?

Accepted Answer

A programmatic rule that automatically identifies inconsistent or out-of-range data entries

Answer

A manual review of CRFs by a monitor

Answer

A final review before database lock

Answer

An IRB audit of study data

Question 5

What is the significance of maintaining an 'audit trail' for GCP compliance?

Accepted Answer

It allows reconstruction of study events and demonstrates data integrity to regulators

Answer

It satisfies financial reporting requirements

Answer

It tracks staff training completion

Answer

It documents IRB meeting minutes

Question 6

What is a 'data management plan' (DMP) in clinical research?

Accepted Answer

A document describing how study data will be collected, managed, validated, and archived

Answer

The sponsor's plan for drug distribution

Answer

The IRB's plan for reviewing data safety reports

Answer

A site's schedule for data entry