Cancer Prevention Network

CPN's clinical trial Study Coordinators or Clinical Research Assistants have a critically important role. They are the individuals on the front line of patient care who make it possible for the Physician investigators to do cancer prevention research. Study Coordinators take responsibility for educating patients, keeping accurate and complete files and records, and insuring compliance with all regulations regarding patient safety and confidentiality.
On behalf of CPN, thank you.

The following documents are available for Study Coordinators:

For all CPN studies:

• CPN Roster and Regulatory Forms Packet, April 2008
• FDA Financial Disclosure Form
• CTEP Financial Disclosure Form
• CTEP Supplemental Investigator Data Form and Instructions
• CPN Site Signature Sheet and Delegation of Duties Log
• CPN Site Monitoring Visit Appointment Log
• CPN Patient Recruitment Log
• Drug Accountability and Record Form
• Pharmacy Audit Form
• DCP's Drug Return Form
• DCP's Serious Adverse Event Form
• DCP's Deviation Notification Form and Policy

Colon cancer prevention study, MAY03-1-03. The next Study Coordinator's Teleconference will be in July.
Minutes of previous teleconferences are available within the Members Only section of the website, on the CPN Directories and Committees page.

• MAY03-1-03 CRF Fax Cover Sheet for faxing CRFs to QCS
• MAY03-1-03 Media Tracking Form
• MAY03-1-03 Chromoendoscopy Central Review Form
• MAY03-1-03 Screening Log Fax cover sheet
• MAY03-1-03 Participant Screening Log
• Colon Study Agent Order Form
• MCLCT Colon Study Kit Order Form

Lung cancer prevention study, MAY03-1-02. The next Study Coordinator's Teleconference will be July 1, 2008 at 1:00 p.m. Central time.
Minutes of previous teleconferences are available within the Members Only section of the website, on the CPN Directories and Committees page.

• Cover sheet for faxing CRFs to QCS
• Agent Order and Reorder Forms
• Revised MCLCT Study Kit Order Form
• Bronchial Tree Diagram
• MAY03-1-02 Participant Screening Log
• MAY03-1-02 Screening Log Fax cover sheet

The Barrett's Esophagus study, MAY04-4-01. The next Study Coordinator's Teleconference will be in late July when we will discuss forms completion and participant recruitment.
Minutes of previous teleconferences are available within the Members Only section of the website, on the CPN Directories and Committees page.

• Fax Cover Sheet for Submission of all CRFs to CPN QCS
• Fax Cover Sheet for Submission of CRF 7 to Crystal Holtz
• Fax Cover Sheet for Submission of CRF 8 to Cassie DeMars
• Esomeprazole Order Form
• MCLCT Study Kit Order Form
• Aspirin/Placebo Order Form
• MAY04-4-01 Participant Screening Log
• MAY04-4-01 Screening Log Fax cover sheet
• Barrett's Esophagus Definitions
• Sample Processing Diagram for Short Segment Barrett's Esophagus
• Sample Processing Diagram for Long Segment Barrett's Esophagus

Common Terminology Criteria for Adverse Events (CTC) V3.0 is available free-of-charge from NCI. There may charge for shipping and handling depending upon how many copies are requested. Call 1-800-4CANCER or go to the following website: https://cissecure.nci.nih.gov/ncipubs/details.asp?pid=1171

You can also access CTCAE v3 MedDRA 9 and 10 codes by clicking here.

CTCAE v3 Map to MedDRA 6 codes (pdf)

If there are any other documents or forms needed, please contact the CPN Operations Office.
Thank you and good luck.