Abstract

The Data Integrity Journey in Clinical Trials from Sponsor Perspective

Diego Herrera, Head, Almirall S A

There is not absence of errors in human activities, but we can reduce that error possibility by preventing the actions and controls, to make data integrity journey happens in clinical trials.

Protocols must be conducted to high scientific and ethical international standards to protect the trial participants and guarantee results are credible.  However, due to the systematic findings from inspections, and the potential impact on the reliability of the trial data, agencies are considering data management findings as “Critical” for Data Integrity.

Clinical personal, but any other professional involved, should be aware about the importance of managing confidential study information, taking preventive actions to protect personal records and sensible data to best fit the purpose of the protocol, and support market applications.

Therefore, sponsors in collaboration with CROs should prospectively identify critical data and map the process to determine data collection, checks, access, transfers, storage and standards from the beginning of the programs. Additionally, sponsor must proactively organise study databases and clinical information reports, to respond upon request for public scrutiny of the results.

The presentation will show our journey to mitigate data integrity risks in clinical trials,  exploring  common issues, and  looking into preventive actions to minimize the impact  of the current complexity,  from the data source to  final clinical study report.