ACRP Source Documentation and Data Integrity 3

Question 1

Which of the following best describes the clinical research coordinator's (CRC) primary responsibility regarding source documentation?

Accepted Answer

Ensuring all protocol-required clinical activities are accurately and contemporaneously documented in source records

Answer

The CRC is primarily responsible for ensuring that every protocol-required clinical activity is documented accurately and in a timely manner in the appropriate source records.

Question 2

In the context of ALCOA documentation principles, 'contemporaneous' means:

Accepted Answer

Documentation recorded at the time of the clinical event or immediately thereafter

Answer

Contemporaneous means that records are made at the time the event occurs or immediately after, minimizing reliance on memory and reducing the risk of documentation errors.

Question 3

A database lock in a clinical trial signifies that:

Accepted Answer

All data queries have been resolved and the database is frozen to prevent further changes prior to statistical analysis

Answer

Database lock indicates that all data cleaning is complete, all queries are resolved, and the database is closed for modifications so that statistical analysis can begin on a finalized dataset.

Question 4

Data cleaning in clinical trials primarily involves:

Accepted Answer

Identifying, querying, and resolving data discrepancies to ensure accuracy and completeness prior to database lock

Answer

Data cleaning involves systematically identifying discrepancies in CRF data, issuing queries to investigative sites for clarification, and verifying resolution to ensure the database is accurate and complete.

Question 5

In clinical research, a data query is issued when:

Accepted Answer

There is a discrepancy, missing data entry, or unclear CRF field that requires clarification or correction by the site

Answer

Data queries are generated by monitors or data managers when CRF entries are missing, inconsistent, out of range, or unclear, prompting the investigative site to review and respond.

ACRP - Association of Clinical Research Professionals Practice Test

ACRP - Association of Clinical Research Professionals Practice Test

ACRP Source Documentation and Data Integrity 3