RA Data Collection & Analysis 5

Question 1

What must usually happen before a clinical trial database is locked?

Accepted Answer

All outstanding data queries must be resolved and data cleaning completed

Answer

Database lock happens only after cleaning is finished and queries are closed, so the data are final for analysis.

Question 2

An EDC system flags an entered age of 250 years right away. What kind of feature is this?

Accepted Answer

Range (edit) check

Answer

Range checks are automated edit checks that flag values outside plausible limits when they are entered.

Question 3

During analysis, an RA notices an extreme outlier weight value. What is the appropriate first action?

Accepted Answer

Verify the value against the source document

Answer

Outliers should be checked against the source first, because they may be real data or transcription errors, and any exclusion must follow the prespecified plan.

Question 4

Which standardized dictionary is commonly used to code adverse events in clinical trials?

Accepted Answer

MedDRA

Answer

MedDRA is the standard medical terminology for coding adverse events for regulatory reporting.

Question 5

Which document defines each variable's name, format, allowed values, and coding (for example, 1 = Male, 2 = Female)?

Accepted Answer

Data dictionary (codebook)

Answer

A data dictionary records variable definitions and coding so data are entered and interpreted consistently.

RA - Certified Research Assistant Practice Test

RA - Certified Research Assistant Practice Test

RA Data Collection & Analysis 5