FDA Rules For Safety Of Clinical Trial Data

Safety information about the clinical trial data in FDA reporting embeds new information from now. The changed rules of FDA insist in inclusion of some crucial information in clinical trial data reporting.

• Information regarding significant risks that affect the study participants should be disclosed in the clinical trial data reporting.
• Higher rate of adverse reactions than the expected should be notified in the clinical trial
• The information regarding the bioavailability studies that determine the amount of drug absorbed by the blood should be notified.
•  Any small reason that believed to be caused by the drug in the clinical trial has to be notified.

FDA also brings the revisions in the reporting standards to help ensure harmonized reporting of globally conducted clinical trials.