Managing eCOA Data: Principles & Best Practices For Data Managers

With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study lifecycle, data managers will deal with data from many sources such as MRI scans, ECG, lab data, as well as eCOA – all of which are equally important. Ultimately, data managers want to collect clean data from all of these sources, smoothly integrate and deliver it in the correct format to the statisticians, and lock their study database(s) as quickly as possible in order to generate the highest quality data possible to ensure regulatory approval. Procedures to do this include Case Report Form (CRF) designing, CRF annotation, database designing, data entry, data validation, discrepancy management, medical coding, data extraction, and database locking.