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Research Groups
Foundations of Prevention:
Basic Prevention Science
Biometry
Cancer Biomarkers
Chemopreventive Agent Development
Community Oncology and Prevention Trials
Early Detection
Funding Opportunities
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Publications and Presentations
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Organ Systems:
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Lung and Upper Aerodigestive Cancer
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Major Programs
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PLCO Cancer Screening Trial
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Key Programs
LSS Manual of Operations and Procedures
Entire Manual
(zip, 8.64mb)
Table of Contents
Introduction
(pdf, 129kb)
Related Appendices
Lung Screening Study Protocol
(pdf, 167kb)
List of Principal Investigators
(pdf, 65kb)
Recruitment, Eligibility Determination, Informed Consent and Randomization
(pdf, 338kb)
Related Appendices
Sample Introductory Letter
(pdf, 156kb)
Fact Sheet
(pdf, 112kb)
Reply Card
(pdf, 99kb)
Answers to Potential Participant Questions
(pdf, 129kb)
Eligibility Screener
(pdf, 131kb)
Specifications for Completion of the Eligibility Screener
(pdf, 176kb)
Prototype Consent Form
(pdf, 115kb)
Sample Informed Consent Cover Letter
(pdf, 113kb)
Eligibility Verification Form
(pdf, 108kb)
Specifications for Completion of the Eligibility Verification Form (EVF)
(pdf, 130kb)
Sample Potential Participant Tracking Log
(pdf, 109kb)
SC Cumulative Recruitment Summary Form
(pdf, 99kb)
Specifications for Completion of the SC Cumulative Recruitment Summary Form
(pdf, 116kb)
Scheduling and Conducting the Screening Visit
(pdf, 103kb)
Related Appendices
Participant Contact Form
(pdf, 110kb)
Specifications for Completion of the Participant Contact Form (PCF)
(pdf, 118kb)
Medical Record Release Authorization Form
(pdf, 87kb)
Spiral Ct Screening Examination
(pdf, 153kb)
Related Appendices
Spiral CT Screening Examination Form (SCT)
(pdf, 130kb)
Specifications for Completion of the Spiral CT Examination Form (SCT)
(pdf, 158kb)
Spiral CT Screening Examination Quality Assurance Form (SCQ)
(pdf, 103kb)
Specifications for Completion of the Spiral CT Quality Assurance Examination Form (SCQ)
(pdf, 132kb)
Chest X-ray Screening Examination
(pdf, 166kb)
Related Appendices
Specifications for Completion of the Chest X-ray Screening Examination Form (XRY2)
(pdf, 165kb)
Specifications for Completion of the Chest X-ray Screening Examination Quality Assurance Form (XRQ2)
(pdf, 158kb)
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Reporting Results of Screening Tests
(pdf, 147kb)
Related Appendices
Result Letter to Participant’s Physician - Positive Screen
(pdf, 94kb)
Result Letter to Participant’s Physician - Negative Screen with Significant Abnormality
(pdf, 85kb)
Result Letter to Participant - Negative Screen with Minor Abnormality
(pdf, 84kb)
Result Letter to Participant - Negative Screen with Smooth
(pdf, 85kb)
Result Letter to Participant - Negative Screen
(pdf, 83kb)
Result Letter to Participant - Inadequate
(pdf, 109kb)
Result Letter to Participant’s Physician - Positive Screen
(pdf, 109kb)
Result Letter to Participant’s Physician - Negative Screen with Significant Abnormality
(pdf, 100kb)
Result Letter to Participant’s Physician - Negative Screen with Minor Abnormality
(pdf, 100kb)
Result Letter to Participant’s Physician
(pdf, 104kb)
Result Letter to Participant’s Physician - Negative Screen
(pdf, 99kb)
Result Letter to Participant’s Physician - Inadequate
(pdf, 100kb)
Weekly Log of Mailed Result Letters
(pdf, 84kb)
Specifications for Completion of the Weekly Log of Mailed Result Letters
(pdf, 117kb)
Follow-Up of Positive Screens Log
(pdf, 83kb)
Specifications for Completion of the Follow-Up Log
(pdf, 113kb)
Follow-up of a Positive Screen
(pdf, 142kb)
Related Appendices
Sample Cover Letter to Request Medical Records
(pdf, 107kb)
Diagnostic Evaluation Form
(pdf, 135kb)
Specifications for Completion of the Medical Record Abstract Form: Diagnostic Evaluation
(pdf, 246kb)
Medical Records Abstraction Quality Assurance Plan
(pdf, 104kb)
Procedures to Assess Contamination
(pdf, 126kb)
Related Appendices
Health Assessment Questionnaire
(pdf, 150kb)
Specifications for Completion of the Health Assessment Questionnaire (HAQ)
(pdf, 146kb)
Sample Cover Letter (Health Assessment Questionnaire)
(pdf, 89kb)
Call Record for the Health Assessment Questionnaire
(pdf, 89kb)
Administrative
(pdf, 140kb)
Related Appendices
Record of Experience, Credentials And Training (ECT)
(pdf, 125kb)
Specifications for Completion of the Record of Experience, Credentials and Training (ECT)
(pdf, 118kb)
Missing Data Form (MDF)
(pdf, 93kb)
Specifications for Completion of the Missing Data Form (MDF)
(pdf, 109kb)
Administrative Tracking Form (ATF)
(pdf, 101kb)
Specifications for Completion of the Administrative Tracking Form (ATF)
(pdf, 98kb)
Protocol Voilation Form (PVF)
(pdf, 122kb)
Specifications for Completion of the Protocol Violation Form (PVF)
(pdf, 120kb)
Report of Adverse Events for NIH-Sponsored Clinical Trials (RAE)
(pdf, 101kb)
Specifications for Completion of the Adverse Events for NIH-Sponsored Clinical Trials (RAE)
(pdf, 121kb)
Comments Continuation Form (CCF)
(pdf, 90kb)
Specifications for Completion of the Comments Continuation Form (CCF)
(pdf, 94kb)
SC Edit Form
(pdf, 110kb)
Specifications for Completion of the SC Edit Form
(pdf, 93kb)
Forms Transmittal Log
(pdf, 104kb)
Specifications for Completion of the Forms Transmittal Log
(pdf, 81kb)
Coordinating Center Edit Form
(pdf, 97kb)
Screening Exam Results Report by SC
(pdf, 86kb)
Expected Forms Report by SC
(pdf, 80kb)
Protocol Discrepancy Report by SC
(pdf, 82kb)
Cumulative Recruitment Summary
(pdf, 82kb)
Exam Results Sent - Summary Report
(pdf, 86kb)
Summary Data Receipt Report
(pdf, 91kb)
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