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MOP): Clinical and Data Management for Using Biomarkers to Predict TB Treatment Duration (Predict TB Trial

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MOP): Clinical and Data Management for Using Biomarkers to Predict TB Treatment Duration (Predict TB Trial Predict TB Trial MOP Version 2.0; 17 September 2017 Manual of Operating Procedures (MOP): Clinical and Data Management for Using Biomarkers to Predict TB Treatment Duration (Predict TB Trial) NIAID Protocol #16-I-N133 Version Number 2.0 Summary of Changes: Number Date Affected Sections Summary of Revisions Made Page 1 of 118 Predict TB Trial MOP Version 2.0; 17 September 2017 Contents 1 Administration ................................................................................................................ 5 Administrative and Institutional Review Board (IRB)/Ethics Committee (EC) Requirements 5 Protocol Amendments ............................................................................................................ 5 Regulatory Requirements and Site Maintained Binders ........................................................ 6 Predict Protocol Team and Key Personnel ............................................................................. 7 2 Training Plan ................................................................................................................. 15 3 Communications Plan ................................................................................................... 16 4 Recruitment and Retention Plan ................................................................................... 16 5 Drug Management and Adherence Monitoring ............................................................. 17 Drug Management ................................................................................................................ 17 Overall Study ......................................................................................................................... 17 Individual Participants .......................................................................................................... 17 Drug Regimen and Dosage .................................................................................................... 17 Completion of Treatment ..................................................................................................... 18 Adherence Monitoring .......................................................................................................... 19 Dose Counting ....................................................................................................................... 19 Medication Event Reminder-Monitor (MERM) Device ......................................................... 20 6 Study Implementation and Data Collection ................................................................... 22 Study Design ......................................................................................................................... 22 Informed Consent Process .................................................................................................... 22 Eligibility Criteria ................................................................................................................... 24 Screening .............................................................................................................................. 25 Enrollment ............................................................................................................................ 27 Scheduling ............................................................................................................................. 27 Day 0/Baseline Visit .............................................................................................................. 27 Study Visits and Randomization ........................................................................................... 29 Management of Participants Who Are Non-Adherent to Medications ................................ 38 Management of Participants With Poor Treatment Response ............................................ 38 Contraindicated and Concomitant Medications ................................................................... 38 Logs, Flows, and Worksheets ................................................................................................ 40 SCREENING VISIT FLOW ........................................................................................................ 40 ENROLLMENT/BASELINE/DAY 0 VISIT FLOW ........................................................................ 41 WEEK 1 VISIT FLOW (+/- 3 day window) ............................................................................... 42 WEEK 2 VISIT (+/- 3 day window) ......................................................................................... 43 WEEK 4 VISIT FLOW (+/- 7 day window) ............................................................................... 44 WEEK 8 VISIT FLOW (+/- 7 day window) ............................................................................... 45 WEEK 12 VISIT FLOW (+/- 7 day window) ............................................................................. 46 WEEK 16 VISIT FLOW (+/- 7 day window) ............................................................................. 47 WEEK 20 VISIT FLOW (+/- 7 day window) ............................................................................. 48 WEEK 24 VISIT FLOW (+/- 7 day window) ............................................................................. 49 WEEK 36 VISIT FLOW (+/- 30 day window) ........................................................................... 50 WEEK 48 VISIT FLOW (+/- 30 day window) ........................................................................... 51 WEEK 60 VISIT FLOW (+/- 30 day window) ........................................................................... 52 WEEK 72 VISIT FLOW (+/- 30 day window) ........................................................................... 53 Recurrence ............................................................................................................................ 54 Page 2 of 118 Predict TB Trial MOP Version 2.0; 17 September 2017 PET/CT VISIT FLOW ............................................................................................................... 55 7 Study Events ................................................................................................................. 56 Criteria for Being Randomized at Week 16 (Protocol Table 6, sec 3.1) ................................ 56 Criteria for Achieving a Study Endpoint ................................................................................ 56 Criteria for Stopping the Study ............................................................................................. 57 Adverse Events (AE), Unanticipated Problems (UP), Deviations, and Non-compliance ....... 58 Definitions ............................................................................................................................. 58 Grading AEs for Severity ....................................................................................................... 59 Assessing Adverse Events for Relationship to Study ............................................................ 60 Recording .............................................................................................................................. 61 Reporting Guidelines ............................................................................................................ 61 Communications Flow for Events ......................................................................................... 64 Medically Accountable Investigator ..................................................................................... 67 Data and Safety Monitoring Board (DSMB) .......................................................................... 67 8 Pharmacokinetic Substudy for Sub-Breakpoint Minimum Inhibitory Concentrations (MIC) Comparison ......................................................................................................................... 68 Substudy Design .................................................................................................................... 68 Eligibility Criteria and Identification of Participants ............................................................. 68 Main Substudy Participants .................................................................................................. 68 Control Participants .............................................................................................................. 69 Substudy Study Visits and Implementation .......................................................................... 69 Procedure for Collection of Substudy Blood Samples .......................................................... 70 Schedule of PK Sample Collection ........................................................................................ 70 9 Data Collection and Correction ...................................................................................... 72 Data Collection Process ........................................................................................................ 72 Source Documentation ......................................................................................................... 72 Research Chart ...................................................................................................................... 73 CRFs ....................................................................................................................................... 73 Database: DataFax ..............................................................................................................
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