Key-person risk in clinical research

Clinical trials run across many sites, and a lot of the coordination still sits with individual monitors and study managers. When one of them is away, queries wait, sites wait and timelines slip.

Where does dependency concentrate in clinical research?

• Site activation. Contracts, approvals and training move forward because one study manager chases them.
• Data queries. Answers from sites wait for the monitor who knows the site.
• Monitoring. Source-data verification needs a monitor at the site.
• Protocol deviations. Patterns are noticed by experienced people instead of by the system.
• Data changes. Data points are corrected after entry because the first entry relied on memory or paper.

Which KPIs does the screening use for clinical research?

• On-site SDV share: share of source-data verification work that needs a monitor at the site.
• Query resolution time: median calendar days from a data query being raised to the site's answer being accepted.
• Patients with protocol deviations: share of enrolled patients with at least one protocol deviation.
• Site activation time: days from site selection to site activation.
• eCRF data changed after entry: share of eCRF data points changed after first entry.

If you do not have a figure, the screening uses the industry median.

What does the audit look at in clinical research?

The workshop follows one study from site selection to database lock and asks who keeps each step moving. The risk-based approach of ICH E6(R3) asks sponsors and CROs to focus on what matters to patient safety and data reliability; HDI shows where that focus depends on individuals.

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