Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials
- 348 Downloads
Data capture, data management, and quality control processes are instrumental to the conduct of clinical trials. Obtaining quality data requires numerous considerations throughout the life cycle of the trial. Case report form design and data capture methodology are crucial components that ensure data are collected in a streamlined and accurate manner. Robust data quality and validation strategies must be employed early on in data collection to identify potential systemic errors. Data management guidance documents provide an opportunity to set clear expectations for stakeholders and establish communication pathways. These tools need to be supplemented with adequate training and ongoing support of trial staff. Trials may be conducted in a single or multicenter setting, which has implications for data management. Risk-based monitoring is one approach that can help data managers target quality issues in a multicenter setting. Evolving technologies such as electronic medical record and electronic data capture system integration, artificial intelligence, and big data analytics are changing the landscape of data capture and management.
KeywordsData management Data collection Data quality Multicenter trial Case report form (CRF) Risk-based monitoring (RBM) Data review Electronic medical record (EMR) Electronic data capture (EDC)
- Food and Drug Administration (2013) FDA guidance oversight of clinical investigations – a risk-based approach to monitoring. https://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf
- Food and Drug Administration (2018) FDA guidance clinical trial endpoints for the approval of cancer drugs and biologics: guidance for industry. https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf
- International Conference on Harmonisation (2018) Guideline for good clinical practice E6(R2) good clinical practice: integrated addendum to ICH E6(R1) guidance for industry. https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf
- McFadden E (2007) Management of data in clinical trials, 2nd edn. Hoboken, NJ: Wiley-Interscience.Google Scholar