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DCP Consortia for Early Phase Trials

Step 3: Monitoring a Cancer Prevention Clinical Trial

These documents are intended for the use of the DCP Consortia staff conducting cancer chemoprevention studies under contract with the NCI/DCP.

SOP #5 Preparing for Annual/Interim Monitoring Visits and Quality Assurance Audit Visits at Consortium Lead Organizations

Responsibilities (SOP) (doc, 69kb)
Lists the Consortia responsibilities during annual/interim monitoring visits and QA audit visits at CLOs.

Checklists/Documents

Site Visit Report Timeline (doc, 62kb)
Use to identify standard timeframes for distribution of site visit reports (initiation, annual/interim or close-out).