AI Article Synopsis
- Investigators and sponsors are shifting from traditional paper case report forms (pCRFs) to electronic case report forms (eCRFs) in clinical research for efficiency.* -
- A comparison of 14 phase III studies (8 using pCRF, 6 using eCRF) indicates that electronic data capture (EDC) offers benefits like improved data quality and quicker clinical decisions.* -
- Effective use of EDC hinges on proper data management processes and the reallocation of resources to support the transition from paper to electronic forms.*
Article Abstract
Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
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