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DCP Consortia for Early Phase Trials

Step 2: Conducting 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 Collection and Submission of Regulatory Documents

Responsibilities (SOP) (doc, 64kb)
Lists the Consortia responsibilities during collection and submission of regulatory documents.

Checklists/Documents

Checklist for Initial Submission of Regulatory Documents (doc, 194kb)
Use as a tool for planning and tracking collection and submission of regulatory documents.

DCP Document Transmittal Form (doc, 41kb)
Use to track document submissions between Participating Organizations and CLO.

Checklist for Subsequent Submission of Regulatory Documents (doc, 79kb)
Use as a tool for planning and tracking collection and submission of regulatory documents required throughout the course of study.