Data Management and Informatics
Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.
- Describe the role that biostatistics and informatics serve in biomedical and public health research
- Describe the typical flow of data throughout a clinical trial
- Summarize the process of electronic data capture and the importance of information technology in data collection, capture, and management
- Describe the ICH GCP requirements for data correction and queries
- Describe the significance of data quality assurance systems and how standard operating procedures are used to guide these processes