ACRP Source Documentation and Data Integrity

Question 1

In clinical trials, 'source data' is best defined as:

Accepted Answer

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

Answer

Data entered directly into the case report form by site staff

Answer

Electronic data only as captured by validated EDC systems

Answer

Data reviewed and approved by the sponsor's data management team

Question 2

Source Data Verification (SDV) is the process of:

Accepted Answer

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

Answer

Entering participant data into the electronic case report form

Answer

Reviewing and approving protocol amendments submitted by the investigator

Answer

Auditing the sponsor's internal data management systems

Question 3

Which of the following is considered a primary source document in a clinical trial?

Accepted Answer

The original hospital medical record containing participant clinical data

Answer

The completed case report form submitted to the sponsor

Answer

The sponsor's clinical database after data entry

Answer

The final clinical study report submitted to the FDA

Question 4

The acronym ALCOA, which defines the principles of good documentation practice in clinical research, stands for:

Accepted Answer

Attributable, Legible, Contemporaneous, Original, Accurate

Answer

Accurate, Legible, Contemporaneous, Original, Attributable

Answer

Accurate, Linked, Certified, Organized, Attributable

Answer

Attributable, Logical, Complete, Organized, Accurate

Question 5

When correcting an error in a paper source document, the accepted regulatory procedure is to:

Accepted Answer

Draw a single line through the error keeping it legible, then write the correction with a date and initials

Answer

Apply correction fluid over the error and write the correct information above it

Answer

Completely cross out the erroneous entry so it is no longer readable

Answer

Remove the page containing the error and replace it with a corrected version

Question 6

The primary purpose of an audit trail in an EDC system is to:

Accepted Answer

Track all changes made to data entries, including who made the change and when

Answer

Speed up data entry by auto-populating common fields

Answer

Prevent unauthorized users from accessing the system entirely

Answer

Automatically generate queries for any missing or inconsistent data

Question 7

Which ICH guideline specifically addresses good clinical practice standards and source documentation requirements for clinical trials?

Accepted Answer

ICH E6(R2) — Guideline for Good Clinical Practice

Answer

ICH E3 — Structure and Content of Clinical Study Reports

Answer

ICH E9 — Statistical Principles for Clinical Trials

Answer

ICH E8 — General Considerations for Clinical Trials