Early Detection Research Group (EDRG)

Key Programs

LSS Manual of Operations and Procedures

Entire Manual (zip, 8.64mb)

Table of Contents

1. Introduction (pdf, 129kb)
   Related Appendices
   • Lung Screening Study Protocol (pdf, 167kb)
   • List of Principal Investigators (pdf, 65kb)
2. 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)
3. 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)
4. 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)
5. 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)
6. 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)
7. 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)
8. 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)
9. 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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