Electronic Data Capture Systems

With the range of technologies available today, a variety of systems exists for the remote electronic data capture of trial data into the sponsor's central database, and the workflow from EDC systems can be fairly uncomplicated. Site personnel enter study data directly into the EDC system instead of first transcribing the information onto paper CRFs. To reduce data queries, logic checks can be built into systems so that inconsistent or out-of-range values can be flagged at the time they are entered. This allows erroneous data to be corrected before it is committed to the trial database, and it prompts for additional explanatory information that may assist in interpretation of the data submitted.

Alternatively, the data may be entered into a locally stored database and then transmitted to the sponsor's database, where it is edited. At some point during the entry process, the system should provide for site review and certification that the information being submitted is consistent with the source documentation (e.g., patient records). For information derived from source documentation at the site, monitoring will still be necessary to verify that the submitted information matches the source database and to reconcile any discrepancies—the same as in paper-based systems.

EDC systems for clinical studies can be categorized as offline or online, differentiated by whether or not an active connection to the study's central database is required. Each type of EDC system is discussed below.

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