Source Data Verification [SDV] is an evaluation of the conformity of the data presented in case report the conformity of the data presented in case report formation reported by an investigator is compared with the original records to ensure that it is complete, accurate and valid. The aim of SDV is to ensure that accurate and valid. The aim of SDV is to ensure that tion and evaluation of the study. Strictly speaking, every item of data that appears in a CRF should be documented somewhere else to allow verification, audit and reconstruction.
The main objective of SDV is to confirm that the information collected during a clinical study is complete, accurate, reliable and verifiable so as to give the regulatory authorities in the data being used to confidence to both the Sponsor Company as well as support a marketing application. SDV is also required to provide confidence in any data reported, for example, in published manuscripts and at scientific conferences. Without SDV, no scientist can have confidence in the data presented and the conclusions derived.