Source Documentation and Data Flashcards

What is the purpose of Source Data Verification (SDV) performed by a clinical monitor?

Answer: To confirm that data transcribed into the CRF accurately matches the original source documents

SDV ensures the integrity of trial data by comparing CRF entries against source documents to identify and resolve discrepancies.

Risk-based monitoring (RBM) approaches may use targeted SDV instead of 100% SDV. What does targeted SDV prioritize?

Answer: Focusing verification efforts on critical data fields and higher-risk sites based on data signals and risk assessment

Targeted SDV concentrates monitoring resources on the most critical data elements and higher-risk areas identified through ongoing risk assessment.

During a monitoring visit, a CRA discovers that source documents for three subjects cannot be located. What is the most appropriate immediate action?

Answer: Document the finding in the monitoring report and work with the site to investigate and resolve the missing records

The monitor must document the missing records, report to the site team, and follow up to determine if records can be located or if a protocol deviation must be reported.

A source document location log is used at a clinical trial site primarily to:

Answer: Identify where source data for each data point can be found across multiple source document types

A source document location log maps each data element or field to its specific source document, enabling efficient SDV and audit trail reconstruction.

Which GCP principle underlies the requirement that investigators retain source documents?

Answer: Regulatory authorities must be able to reconstruct and evaluate the trial's conduct and data integrity through retained records

GCP requires document retention to allow regulatory authorities to audit and verify that the trial was conducted properly and that data are reliable.

If a subject's primary source data exists in hospital records held by an institution, what is the investigator's responsibility?

Answer: The investigator must ensure the sponsor's monitor can access those records for SDV, as permitted by applicable regulations

The investigator is responsible for ensuring monitors can access source data needed for verification, within the constraints of privacy and confidentiality agreements.

Which of the following represents a source data discrepancy that would require immediate escalation beyond routine query resolution?

Answer: Evidence that source documents were backdated to conceal a protocol deviation affecting subject safety

Backdating or falsification of records to conceal safety-relevant deviations constitutes potential research misconduct requiring escalation per sponsor and regulatory SOPs.