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-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-018-CT_Management of Specific Adverse Events_V3.2_20Jun2023.docx (105.57 KB)
- SP-018-CT_A1_Adjustments of Anti-TB Drugs in Renal Insufficiency_V1.0_23Sep2018.docx (61.82 KB)
- SP-018-CT_A2_Clinical Manifestation, Prevention, and Diagnosis of Deep Venous Thrombosis Pulmonary Embolism_V1.0_23Sep2019.docx (51.42 KB)
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-024-CT_Modus Operandi and Communication with Clinical Advisory Committee_V2.0_02Sep2019.docx (74.63 KB)
- SP-024-CT_A1_Clinical Advisory Committee Contact List_V1.0_02Sep2019.docx (49.18 KB)
- SP-024-CT_endTB_A2_Clinical Advisory Committee Request Form_02Sep2019.docx (70.33 KB)
- SP-024-CT_endTB-Q_A2_Clinical Advisory Committee Request Form_V1.0_02Sep2019.docx (72.52 KB)
SP-025-CT Management of Comorbidities
SP-026-CT Treatment Outcome
SP-028-CT Management of Early Termination
SP-031-CT Event Validation
- SP-031-CT_Event Validation_V2.0_22Feb2022.docx (85.66 KB)
- SP-031-CT_A1_Treatment Outcome Validation Process - Flowchart_V2.0 22Feb2022.docx (97.7 KB)
- SP-031-CT_A2 Event validation Document W39_04Nov2020.pdf (821.82 KB)
- SP-031-CT_A2 Event validation Document W73_04Nov2020.pdf (859.2 KB)
- SP-031-CT_A2 Event validation Document W104_04Nov2020.pdf (858.08 KB)