USE OF COMPUTERISED SYSTEMS AT THE CLINICAL TRIAL CENTRE Sample Clauses

USE OF COMPUTERISED SYSTEMS AT THE CLINICAL TRIAL CENTRE. When clinical observations are entered directly into an investigational site’s computerised medical record system (i.e. in lieu of original hardcopy records), the electronic record can serve as the source document if the system has been validated in accordance with health authority requirements pertaining to computerised systems used in clinical research. An acceptable computerised data collection system allows preservation of the original entry of data. If original data are modified, the system should maintain a viewable audit trail that shows the original data as well as the reason for the change, name of the person making the change, and date of the change. The system must allow the clinical research associate, auditors or inspectors to verify source data without infringing privacy rights of other patients, e.g. access must be restricted to records pertaining to the study patients and access to other patients must not be possible.
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