What is source data verification?
Source data verification (SDV), a verification of the conformity of the data presented in case report forms with source data, is conducted to ensure that the data collected are reliable and allow reconstruction and evaluation of the trial and therefore seemingly fulfil ICH E6’s requirements of accuracy, completeness …
What is the difference between SDV and SDR?
SDR, according to the consortium, “is not a comparison of source data against CRF (case report form) data,” but rather, “a review of source documentation to check quality of source, review protocol compliance and ensure critical processes and source documentation are adequate.” SDV, on the other hand, is defined as “ …
What is source document verification in clinical trials?
Source document verification (SDV)—the comparison of reported trial data with information from primary health records of trial subjects—is an important component of trial monitoring intended to ensure the integrity of trial data.
Why is SDV important?
Its primary purpose is indeed to verify that the information transcribed into the eCRF is complete and consistent with source records, but also that eCRF and source together meet various protocol and clinical expectations.
How is source data verification used in clinical trials?
Source data verification in clinical trials involves considerable resources and limited evidence for benefit is available. Historically, up to 100% source data verification have been used. Authorities have recently presented guidelines that promote risk-based monitoring.
What does SDV stand for in clinical trials?
A significant portion of the growing costs of clinical trials, and hence drug development, relates to source data verification (SDV), a
How is source data capture used in clinical research?
Page 5 / 50 EXECUTIVE SUMMARY Accessing research data directly from Electronic Health Records (EHRs), known as electronic source data capture (eSource), can create efficiencies in the clinical research process while improving data quality, reducing cost, maintaining integrity and preserving audit trails.
What to do if data verification is no longer feasible?
If on-site is no longer feasible, alternative methods to be considered: postpone SDV and SDR, phone and video visits, centralized monitoring and centralized review of data.