CLINI INDIA students got an opportunity to meet and Interact with Industry Professionals during a SDE, Hosted by SCDM, India (Society for Clinical Data Management, India). The event was hosted on Saturday, 16th June 2019, Where is professionals from leading Pharma, IT and CROs participated.
Understanding the Fundamentals of Data Integrity in Collecting Clinical Data
In the Academic Workshop, experts from Novartis and Parexel took the participants on the fundamentals of Data Integrity in collecting Clinical Data. Participants were guided for Clinical Trials background and it’s lifecycle and the importance of Data Integrity in Data Management. All the participants got and insights on Regulatory perspectives on Data Integrity including ALCOA, FDA’s Data Integrity Focus, during the workshop. An insightful learning was fulfilled for the participants as they brainstormed and discussed in groups on potential Data Integrity issues during data collection and data review and cleaning phases. There were 2 groups were formed during the event, which helped them to understand the case study in effective manner.
Date: June 15, 2019
Location: Radisson Hyderabad Hitec City
Gachibowli, Next The Platina Building,
On the way of Gachibowli to Kondpur Road,
Hyderabad, Telangana, 500032, India.
Data Integrity is one of the most important areas of consideration for clinical development these days where use of technology support is being increasingly adopted. FDA investigators continue to cite a significant number of data integrity observations during inspection. There has been an increase in regulators taking action against data fraud or false information. They are keeping pressure on those with data integrity shortcomings, issuing a growing number of warning letters and FDA-483s every year for the last few years. The analysis below shows that the data integrity findings (largely cGMP) from FDA has increased from just 4 instances in 2004 to 56 in 2017 which is around 37% of the total number of data integrity findings in 10 years across the globe.
(*)Courtesy: Barbara Unger, Unger Consulting Inc.