SOCRA Source Documentation and Data 2

Question 1

Which ALCOA principle requires that data be recorded at the time the observation is made?

Accepted Answer

Contemporaneous

Answer

Contemporaneous means data must be recorded at the time the observation occurs, not reconstructed later from memory.

Question 2

When correcting an error in a paper source document, what is the correct procedure?

Accepted Answer

Draw a single line through the error, write the correct value, and initial/date the correction

Answer

A single line through the error preserves the original entry while clearly indicating the correction, with initials and date for accountability.

Question 3

What does 'source data' refer to under ICH E6(R2) GCP guidelines?

Accepted Answer

All information in original records and certified copies of findings, observations, or other activities

Answer

ICH E6(R2) defines source data as all information in original records and certified copies used to reconstruct and evaluate a clinical trial.

Question 4

Which scenario represents a violation of the 'Attributable' ALCOA principle?

Accepted Answer

A data entry clerk enters data under another staff member's login credentials

Answer

Using another person's login credentials violates attributability because the data cannot be traced to the person who actually performed or recorded it.

Question 5

A certified copy of a source document is best described as:

Accepted Answer

A verified copy that preserves the content and meaning of the original, often with a certification statement

Answer

A certified copy is one that has been verified to be an exact and complete copy of the original, preserving all data and attributes.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Source Documentation and Data 2