CCDM Clinical Data Collection & Management 3

Question 1

During database lock preparation, a discrepancy is found between the randomization code list and the study database. What should the data manager do first?

Accepted Answer

Place the database on hold and investigate the discrepancy before locking

Answer

The database must not be locked until all discrepancies between source randomization data and the database are resolved to ensure data integrity and regulatory compliance.

Question 2

Which type of data validation check would catch a subject age recorded as 250 years?

Accepted Answer

Range check

Answer

A range check flags values outside predefined minimum and maximum limits, such as an impossible age of 250 years.

Question 3

A sponsor decides to transition from paper CRFs to an EDC system mid-study. What is the most critical data management consideration?

Accepted Answer

Ensuring a validated migration plan that maintains data integrity and provides a clear audit trail

Answer

A validated migration plan is essential to ensure that existing data is accurately transferred to the EDC system and that the audit trail remains intact.

Question 4

What is the primary function of a 'data monitoring committee' (DMC) in a clinical trial?

Accepted Answer

To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination

Answer

A DMC independently monitors unblinded interim data to protect participant safety and study integrity, with authority to recommend changes to the trial conduct.

Question 5

Under 21 CFR Part 11, which of the following is required for electronic signatures used in clinical research?

Accepted Answer

A unique combination of identification code and password with binding documentation linking the signature to the record

Answer

21 CFR Part 11 requires electronic signatures to be uniquely linked to the signer via credentials, and the organization must have documentation binding the electronic signature to the individual.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Clinical Data Collection & Management 3