Twelve user requirements for source data developed by CDISC form the basis of the European Union's expectations for the handling of electronic data in clinical trials. The principles embodied in the 12 requirements, detailed in the CDISC Standards and Electronic Source Data within Clinical Trials, 20 November 2006, "provide a good basis for the acceptability of source data," according to the EU's reflection paper, and therefore represent good clinical practice.
The EU GCP Inspectors Working Group has sorted the 12 tenets into five topics: system creation and modification; data creation, modification and transfer; source document control; copying; and storage. The document represents the current expectations of GCP inspectors: "Any departure would need to be justified."
Ultimately, "integrity of data must be confirmable," the document says. To protect patient safety, all data must be available to the investigator. Data held by the sponsor should be verifiable by a copy held elsewhere.
- see the paper