2 General laboratory 3 Molecular biology laboratory 4 Pharmacy or medical store If no pharmacy or medical available, describe handling and storage of medicines: 5 Office space for data management 6 Is transportation available for patient follow-up? Public transportation Private car Other (specify): 4. DOCUMENTS Are the following essential study documents available at – Yes No N/A the study site? 1 Approved protocol and amendments, if any 2 Approved informed consent and assent 3 Approved translation of informed consent and assent 4 Letters of approval from ethical committees Screening forms/screening logbook 5 6 Case report forms/enrolment logbook 7 Serious adverse event forms 8 Laboratory register 9 Drug inventory log/registry/form 10 (specify): 5. RESOURCES, MATERIAL AND SUPPLIES (CLINICAL) Are facilities, – material and supplies for clinical assessments available and in good Yes No N/A working order? 1 Clinical examination room (space, cleanliness) 2 Stethoscopes 3 Scale for children (calibrated) 4 for adults (calibrated) 5 Thermometers (mercury or digital) and battery if electronic thermometer (calibrated) 6 Medicines for the study including rescue treatment (see 6. Drug inventory) 7 Syringes 2 ml, 5 ml and needles 8 Sphygmomanometer (blood pressure monitor) 9 Other (specify): 6. Drug inventory Adequate Storage Formulation Expiry date quantity <30°C
2 General laboratory 3 Molecular biology laboratory 4 Pharmacy or medical store If no pharmacy or medical available, describe handling and storage of medicines: 5 Office space for data management 6 Is transportation available for patient follow-up? Public transportation Private car Other (specify): 4. DOCUMENTS – Are the following essential study documents available at the study site? Yes No N/A 1 Approved protocol and amendments, if any 2 Approved informed consent and assent 3 Approved translation of informed consent and assent 4 Letters of approval from ethical committees 5 Screening forms/screening logbook 6 Case report forms/enrolment logbook 7 Serious adverse event forms 8 Laboratory register 9 Drug inventory log/registry/form 10 (specify): 5. RESOURCES, MATERIAL AND SUPPLIES (CLINICAL) – Are facilities, material and supplies for clinical assessments available and in good working order? Yes No N/A 1 Clinical examination room (space, cleanliness) 2 Stethoscopes 3 Scale for children (calibrated) 4 for adults (calibrated) 5 Thermometers (mercury or digital) and battery if electronic thermometer (calibrated) 6 Medicines for the study including rescue treatment (see 6. Drug inventory) 7 Syringes 2 ml, 5 ml and needles 8 Sphygmomanometer (blood pressure monitor) 9 Other (specify): 6. Drug inventory Formulation Expiry date Adequate quantity Storage <30°C
tes-monitoring-checklist-interim-visit.docx