For those of us that conduct clinical trials, we know success or failure rests with our data. Whether it is efficacy, accuracy, security, or all the above, it is the data we collect that will drive promising new therapies or result in wasted time and money. Most importantly, patients treated in clinical trials rely on the integrity of our data to ensure their safety. As such, global health authorities are increasingly paying attention to data, and taking action against those who do a poor job of maintaining compliance with regulations.
In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” which outlined the agency’s thinking on data integrity best practices. In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations. This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop. In addition, you will examine several best practices for data collection and ensuring that data is correct and secure.
This interactive, 90-minute session, will cover the following key topics:
- Identification and mitigation of data integrity issues
- Identification of the four significant factors impacting data integrity
- Best practices to support data integrity
- Regulations and expectations from the regulatory authorities
- Leveraging technology to enhance data integrity
- Review of case studies (adapted from the FDA/MHRA GCP Data Integrity Workshop)