Reporting and Tracking SAEs

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.

Responsibilities (SOP) (doc, 69kb)
Lists the Consortia responsibilities during reporting and tracking of SAEs.

DCP Serious Adverse Event Form (doc, 80kb)
Use to report and track Serious Adverse Events (SAEs).

Serious Adverse Event Form Instructions for Completion (doc, 135kb)
Use as a reference to complete the DCP Serious Adverse Event Form.

Summary of Reporting Responsibility for Serious Adverse Events (SAEs) (doc, 41kb)
Use as a reference to review SAE reporting responsibilities for CLO and Participating Organization staff.