2012 Consortia for Early Phase Prevention Trials

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

Standard Operation Procedures (SOPs) for the 2012 Consortia are being finalized. These links are to important documents used in the SOPs. Additional materials will be added as they are completed.

Study Status and Amendments
- Study Status Update Form (doc, 28kb)
Adverse Events and Protocol Deviation
- DCP Serious Adverse Events Reporting Form (doc, 80kb)
- Serious Adverse Event Form Instructions for Completion (doc, 135kb)
- DCP Consortia Protocol Deviation Form (doc, 92kb)
Agents/Drugs
- DCP Policy and Guidelines for Investigational Agent Distribution (doc, 32kb)
- DCP Guidelines for Submitting Clinical Drug Requests (doc, 27kb)
- DCP Return Agent Form (doc, 65kb)
- DCP Guidelines for Submitting Study Site Inventory (doc, 26kb)
- DCP Form for Submitting Study Site Inventory (doc, 67kb)
- DCP Drug Request Form (doc, 49kb)
Investigator Registration
- FDA Form 1572 (pdf, 330kb)
- DCP Financial Disclosure Form (pdf, 89kb)
- DCP Delegation of Tasks Form (doc, 64kb)
Recording and Reporting Protocol Deviations
- DCP Consortia Protocol Deviation Form (doc, 80kb)
  Use to record and report protocol deviations.

Standard Operation Procedures (SOPs) for the 2012 Consortia are being finalized. These links are to important documents used in the SOPs. Additional materials will be added as they are completed.

Monitoring
- DCP Multicenter Guidelines for Chemoprevention Trials (doc, 30kb)
Reports
- Minimum Data Set Instructions (pending)
- Quarterly Reports (pending)
- Annual Report (pending)

Clinical Trials Resource Step-by-Step
Instructions for Consortia Members