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

A filing system

Answer

An AE classification

Answer

A budgeting method

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

Only the CRF

Answer

Only electronic records

Answer

Only sponsor documents

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

Optional and rarely performed

Answer

Only checks demographics

Answer

Only at trial end

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

No special requirements

Answer

Only paper is valid

Answer

Can be freely modified

Question 5

What is a data query?

Accepted Answer

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

Answer

Request for medication

Answer

Only generated by IRB

Answer

Resolved without documentation

Question 6

What is a certified copy?

Accepted Answer

A verified exact, complete, and unaltered reproduction of the original

Answer

Any photocopy

Answer

Never acceptable

Answer

Only FDA can create them