ACRP Source Documentation and Data Integrity 1 — Questions and Answers
Question 1: In clinical trials, 'source data' is best defined as:
- Data entered directly into the case report form by site staff
- All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial (Correct answer)
- Electronic data only as captured by validated EDC systems
- Data reviewed and approved by the sponsor's data management team
Correct answer: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial
Per ICH E6(R2), source data includes all information in original records and certified copies of original records of clinical findings, observations, or activities in a clinical trial.
Question 2: Source Data Verification (SDV) is the process of:
- Entering participant data into the electronic case report form
- Comparing CRF data against source documents to confirm accuracy, completeness, and consistency (Correct answer)
- Reviewing and approving protocol amendments submitted by the investigator
- Auditing the sponsor's internal data management systems
Correct answer: Comparing CRF data against source documents to confirm accuracy, completeness, and consistency
SDV involves comparing data recorded in CRFs against source documents to verify that the transferred data is accurate, complete, and consistent with the original records.
Question 3: Which of the following is considered a primary source document in a clinical trial?
- The completed case report form submitted to the sponsor
- The sponsor's clinical database after data entry
- The original hospital medical record containing participant clinical data (Correct answer)
- The final clinical study report submitted to the FDA
Correct answer: The original hospital medical record containing participant clinical data
Original hospital medical records are primary source documents because they contain clinical data in its original form before any transcription to CRFs or other records.
Question 4: The acronym ALCOA, which defines the principles of good documentation practice in clinical research, stands for:
- Accurate, Legible, Contemporaneous, Original, Attributable
- Attributable, Legible, Contemporaneous, Original, Accurate (Correct answer)
- Accurate, Linked, Certified, Organized, Attributable
- Attributable, Logical, Complete, Organized, Accurate
Correct answer: Attributable, Legible, Contemporaneous, Original, Accurate
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — the five foundational principles of good documentation practice in clinical trials.
Question 5: When correcting an error in a paper source document, the accepted regulatory procedure is to:
- Apply correction fluid over the error and write the correct information above it
- Completely cross out the erroneous entry so it is no longer readable
- Draw a single line through the error keeping it legible, then write the correction with a date and initials (Correct answer)
- Remove the page containing the error and replace it with a corrected version
Correct answer: Draw a single line through the error keeping it legible, then write the correction with a date and initials
The accepted procedure is to draw a single line through the error (preserving legibility), then write the correct information alongside with the date and initials of the person making the correction.
Question 6: The primary purpose of an audit trail in an EDC system is to:
- Speed up data entry by auto-populating common fields
- Track all changes made to data entries, including who made the change and when (Correct answer)
- Prevent unauthorized users from accessing the system entirely
- Automatically generate queries for any missing or inconsistent data
Correct answer: Track all changes made to data entries, including who made the change and when
An audit trail records every action performed on data entries — including modifications and deletions — along with the identity of the user and timestamp, ensuring data integrity and traceability.
Question 7: Which ICH guideline specifically addresses good clinical practice standards and source documentation requirements for clinical trials?
- ICH E3 — Structure and Content of Clinical Study Reports
- ICH E6(R2) — Guideline for Good Clinical Practice (Correct answer)
- ICH E9 — Statistical Principles for Clinical Trials
- ICH E8 — General Considerations for Clinical Trials
Correct answer: ICH E6(R2) — Guideline for Good Clinical Practice
ICH E6(R2) is the GCP guideline that defines source data, source documents, and the standards for documentation that sponsors and investigators must follow in clinical trials.
ACRP Source Documentation and Data Integrity 1
In clinical trials, 'source data' is best defined as: