Japan Health Authorities Mull Five-Year Clinical Research Retention Rule
This article was originally published in PharmAsia News
Executive Summary
Clinical researchers in Japan would be required to retain research data for at least five years so investigators would be able to track suspicious research conclusions, according to a proposal floating in the health ministry.
Clinical researchers in Japan would be required to retain research data for at least five years so investigators would be able to track suspicious research conclusions, according to a proposal floating in the health ministry. The intention is to make it easier to trace data used to show the efficacy of a drug in trials such as the one involving the Novartis Pharma KK drug Diovan (valsartan) for treating high blood pressure. The health and Science and Technology Ministries are compiling a set of proposals to present at an Aug. 22 ethical-guidelines meeting. (Click here for more - a subscription may be required)
"Government To Require Drug-Research Data To Be Kept Up To Five Years" - Nikkei (Japan) (8/8/2013)