endTB Trials: Medical

Introduction for medical standard documents 

These medical standard documents are prepared by the Sponsor medical specialists. They describe how the various medical procedures are performed such as mental health assessment, visual acuity testing, colour-blindness testing, etc... You may adapt them to your specific needs. Medical management SOPs, such as management of adverse events, comorbidities, etc., should only be considered updated to the date of final approval (e.g., optical management may have evolved and should be re-assessed). Please note that the Sponsor does not bear responsibility for their use. 

Clicking on a medical standard document will direct you to a page that includes the procedure and any relevant appendices. You can download any document by simply clicking on it. To return to the of medical standard documents, use the link titled: endTB Trials: Medical. 

SP-002-ET Brief Peripheral Neuropathy Screening

SP-003-ET Visual Acuity Screening

SP-004-ET Color Blindness Screening

SP-005-ET Measuring and Recording Vital Signs

SP-006-ET Eastern Cooperative Oncology Group Performance Status

SP-007-ET Audiometry Screening

SP-008-CT Electrocardiogram Reading

SP-009-ET Chest X-ray Reading

SP-010-CT Medical History Collection

SP-011-CT Physical Examination

SP-012-CT Mental Health Assessment

SP-013-CT Eligibility Evaluation

SP-015-CT Regimen Design for endTB

SP-017-CT Treatment and Study Adherence Counseling and Support including Directly Observed Treament & Handling of Missed Doses

SP-018-CT Management of Specific Adverse Event

SP-019-CT Concomitant Medications

SP-021-CT Chest X-ray Reporting

SP-022-CT Subject Tracing

SP-024-CT Communication with Clinical Advisory Committee

SP-025-CT Management of Comorbidities

SP-026-CT Treatment Outcome

SP-028-CT Management of Early Termination

SP-031-CT Event Validation

SP-032-CT Evaluating Bacteriological, Radiographic & Clinical Evolution for Outcome Classification

SP-033-CT Management of Hepatitis C

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