Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations

Conclusions: TransCelerate recommends the creation of an integrated, multifaceted approach to proactively detect data quality issues. Detection methods should include a strategy tailored to the characteristics of the study. Some sponsors are taking advantage of more advanced methods and integrated processes and systems to proactively detect and address issues, relying on advances in technology to more efficiently review data in real time. Further research is underway to assess statistical data quality detection methodology in clinical trials.

http://dij.sagepub.com/cgi/content/abstract/50/1/15?rss=1

Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Knepper, D., Fenske, C., Nadolny, P., Bedding, A., Gribkova, E., Polzer, J., Neumann, J., Wilson, B., Benedict, J., Lawton, A. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research