The eSDI document is the product of the CDISC eSDI Initiative, the purpose of which was "to investigate the use of electronic technology in the context of existing regulations for the collection of eSource data (including that from eDiaries, EHR, EDC) in clinical trials for regulatory submission by leveraging the power of the CDISC standards, in particular the Operational Data Model (ODM)".
The overarching goals are to make it easier for physicians to conduct clinical research, collecting data only once in an industry standard format for multiple downstream uses, and thereby to improve data quality and patient safety.
The eSDI Document includes:
- An extensive review and analysis of the relevant existing regulations
- Twelve requirements for conducting regulated clinical research using eSource data collection in the context of existing regulations
- Five potential scenarios, three of which include the use of electronic health record systems (EHR), and associated benefits of standards
- An Appendix on Responsibilities of each of the various functional groups conducting clinical research
- A Template for evaluating an eSource data collection process against the requirements
- A Good Practices Checklist for Investigators
eSDI Document (pdf)