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 #2 Conducting Study Initiation Visits
Responsibilities (SOP) (doc, 71kb)
Lists the Consortia responsibilities during the conducting of study initiation visits.
Checklists/Documents
Attendance Sheet (doc, 36kb)
Use as a tool to document attendance of each participant, either in-person or remote, in the study initiation visit.
Site Monitoring Visit Log (doc, 46kb)
Use to document monitor and site staff attendance during the site visit.
Clinical Study Initiation Visit Report (doc, 169kb)
Use to document findings of study initiation visits. It can also be used as a preparation worksheet for initiation visit tasks.
Site Visit Report Timeline (doc, 62kb)
Use to identify standard timeframes for distribution of site visit reports (initiation, annual/interim or close-out).
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