| Source Data Verification (SDV) | Quelldatenabgleich |
| Among other important tasks, during a monitoring visit the clinical research associate will perform source data verification, meaning a review of all source data. Depending on the provisions set out in the monitoring manual, this may be partial or complete (100% SDV) verification. The CRA will then verify the data collected in the CRF against the source data available at the investigational site. The corresponding source data in the patient’s file must be available for each CRF entry and stored according to the site’s applicable retention period.
In accordance with ICH GCP, source data are “any information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.” This applies among others to medical records, patient index, laboratory records, medical reports, diaries of subjects or self-assessment scales, records concerning dispensing of medicinal products, x-ray images, etc. |
Deutsche Erklärung |
