Category Archives: Clinical Research

Traceability Starts at the Source

Doctor doing research on scrubs and mask.

Micki Duerre (Principal Clinical Research Associate) Traceability Starts at the Source: Part 1, Navigating eCRFs, Worksheets, and eSource Why Missing Source Matters In my experience as a monitor, the fastest way to uncover hidden risks in a clinical trial is to start with the source. Source documentation tells the story the case report forms (CRFs) […]

Monitoring the Informed Consent Process in Clinical Research: Beyond the Signature

Clinical Research doctor

By Micki Duerre (Principal Clinical Research Associate) In clinical research, informed consent is far more than a signature on a form – it is the foundational process that supports ethical participation and regulatory compliance. As clinical trial professionals, we understand that the consent process is not just an ethical obligation; it is a legal requirement, […]