SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 2

Question 1

What are the ALCOA principles for source documentation?

Accepted Answer

Attributable, Legible, Contemporaneous, Original, and Accurate

Answer

ALCOA requires data to be Attributable, Legible, Contemporaneous, Original, and Accurate.

Question 2

What qualifies as a source document?

Accepted Answer

Original documents including medical charts, lab reports, pharmacy logs, ECG tracings, and participant diaries

Answer

Source documents are all original records where clinical data are first recorded.

Question 3

What is SDV's role in data quality?

Accepted Answer

Comparing CRF data against source documents to confirm accuracy, completeness, and consistency

Answer

SDV involves monitors comparing CRF entries against original source documents.

Question 4

How should electronic source data be managed?

Accepted Answer

In validated systems with audit trails, access controls, backups, and 21 CFR Part 11 compliance

Answer

Electronic source data must comply with 21 CFR Part 11 including validation, audit trails, and access controls.

Question 5

What is a data query?

Accepted Answer

A formal question about unclear or erroneous data requiring site investigation and resolution

Answer

A query is a formal request for clarification or correction of unclear, inconsistent, or erroneous data.

(SOCRA) Society of Clinical Research Associates Practice Test