Source Data Verification (SDV) is an evaluation of the conformity of the data presented in case report form (CRF) with source data (original records or certified copies), is conducted to ensure that the data collected are reliable and allow reconstruction and evaluation of the study.
Special attention is paid to key data in SDV of the clinical trial such as:
• A record that the patient has entered a clinical study and the date of informed consent;
• Primary efficacy data;
• Inclusion/Exclusion criteria;
• Medical and medication history;
• Adverse events;
• Concomitant medication;
• Administration of Investigational Product.
SDV performed by our CRA is needed in order to confirm that the information collected during a clinical trial is complete, accurate, reliable and verifiable, so as to give confidence to the client in the data being used to support a marketing application, publications and scientific conferences.