Data from three periods were analyzed to compare success rates in reducing errors in source document and case report form documentation. .
Results: Internal monitoring SDV reports were performed by four monitors during three periods from March to August 2012, September to December 2012 and January to April 2013 for 26 protocols, 486 cases and 1069 visits. There were 5,594 findings. There were significantly fewer findings in all three periods. Improvements were observed in fewer missing information in source documents, protocol deviations/violation and incomplete informed consent forms. However, improper documentation (using white-out/pencil to record in source documents) was increased likely due to involvement of new staff. .
Limitation: Even though four monitors have received the same training to monitor clinical trials. However, there is no standardization between four monitors in this study. This may cause some affect to findings of the study.
Conclusion: Real-time source document data verification resulted in significant improvement in reducing missing information in source document and protocol violation/deviation. However, the analysis identified areas that did not improve which will guide targeted interventions in improving the overall quality of clinical trials data. .
Keywords: Source data verification, monitoring, monitoring findings and clinical trials.
Introduction .
Source data verification (SDV) is an important component of trial monitoring that is intended to ensure the integrity of trial data. 1 This is done by checking recorded data in the case report forms (CRF) against the primary source data such as the study volunteers' medical records.2 This task is generally delegated by the sponsors and principal investigators to trial monitors. In the International Conference on Harmonization Good Clinical Practice (ICH-GCP) Guideline, a key role of the monitor is to verify that the data required by the protocol are reported accurately on the CRF and are consistent with the source documents (SD).
