Conducting Close-Out Visits at Participating Organizations

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DCP Consortia for Early Phase Trials

Step 4: Closing Out a Cancer Prevention Clinical Trial

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

SOP #1: Conducting Close-out Visits at Participating Organizations

Responsibilities (SOP) (doc, 46kb)
Lists the Consortia responsibilities in the conduct of the close-out site visit at the participating organizations.

Checklists/Documents

Clinical Site Annual (Interim) Monitoring Report (doc, 130kb)
Use in addition to the Clinical Site Close-out Visit Report if chart reviews were performed in addition to the close-out visit.

Clinical Site Close-Out Visit Report (doc, 58kb)
Use to document findings from the clinical site close-out visits. It can also be used as a preparation worksheet for monitoring tasks during the close-out visit.

Site Monitoring Visit Log (doc, 46kb)
Use to document monitor and site staff attendance during the site visit.

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