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Year : 2000  |  Volume : 32  |  Issue : 3  |  Page : 180-186

Efficient source data verification

Correspondence Address:
R Khosla

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Source of Support: None, Conflict of Interest: None

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The ICH harmonised tripartite guidelines for good clinical practice, the WHO guidelines for good clinical practice for trials on pharmaceutical products and the FDA's Code of Federal Regulations require that source data verification must be undertaken for all clinical trials in phases I-IV. SDV, which is an evaluation of the conformity of the data presented in case report form with source data, is conducted to ensure that the data collected are reliable and allow reconstruction and evaluation of the study. The responsibilities of the principal investigator, sub-investigator, study coordinator, monitor, quality assurance auditor and the clinical trial manager in SDV must be made clear at the outset of the clinical trial and adequate training should be provided to the personnel involved. Special emphasis should be placed on direct access to data and confidentiality, so that there are no misunderstandings and errors when SDV is undertaken. Meticulous recording of what was done and found, including an evaluation of the findings, must be made to arrive at an indication whether the errors are random or systematic errors and are arising due to carelessness or deliberate actions. All personnel involved must realize that SDV adds to the scientific and ethical integrity of the clinical trial. This review highlights the various aspects governing the conduct, extent, difficulties and stream lining of the process of SDV and gives some suggestions for fast and effective SDV avoiding the common pitfalls observed by the clinical trial monitors.


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