The goal of FDAs Bioresearch Monitoring Branch is to protect the safety, health and rights of human subjects that are participating in a clinical trial study. This group typically will conduct pre-license and pre-approval data verification inspections, investigate complaints, answer questions about Good Clinical Practice (GCP) and help evaluate concerns about data integrity. In order to do all these tasks quickly and consistently, the submission of your clinical trial study data needs to be standardized to help the FDA streamline the review process and enable consistent use of analysis tools throughout all trials.
Providing the DIA with high quality and well-structured data will prevent potential delays in data extraction, site selection, and data management process thus helping you drive your product to market faster.
Here are some of the more common pitfalls that we see when submitting study data
Site ID variability or was not included
Dataset submitted did not include standardized data variables
Protocol deviations submitted as pdf listings and not in a searchable format
Subjects were not listed using standardized ID variables
Definition files were not user friendly and the definition of dataset variables were not available
Critical endpoint data (rows of data) are missing that were possibly due to inadequate data validation by sponsor
The normal review process can take up to 60 days (Figure 1). If the data is not standardized, it’s very difficult to go through all the data in this length of time. The best way to ensure you submit good quality data to the FDA is to have advance discussions with your sponsor and the FDA on your study data standardization plan (SDSP). Topics will include information about e-source data collection and/or data extraction from electronic data capture (EDC) systems and data integration.
The FDA has numerous references on clinical trial standardization best practices but probably the most concise is the FDA Study Data Standards fact sheet.
For more information on the background and helpful tips please listen to the 20-minute webinar of Dr. Bhanu Kanna of the FDA Center for Biologics Evaluation and Research.
Do you have any additional references to share for best practices of clinical trial data standardization? Please comment below.