Source Documentation and Data Integrity Flashcards

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

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.

Source Data Verification (SDV) is the process of:

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.

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

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.

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

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.

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

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.

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

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.

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

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.