On-site monitoring

For when an investigator/institution takes responsibility for on-site monitoring of a clinical trial



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While monitoring is usually a sponsor’s responsibility, there may be circumstances where the PI takes on the monitoring. Monitoring may also be on-site (i.e. where someone physically visits the trial site) or off-site (where monitoring is done remotely to the site). This procedure describes the process and documentation required for the on-site monitoring of a clinical trial by a PI’s team.

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