WHO TES monitoring checklist: study interim visit



A. GENERAL STUDY INFORMATIONStudy title: ___________________Protocol and version number: ___________________Principal Investigator: ___________________Country of study: ___________________Target sample size: ___ (P. falciparum) ___ (P. vivax)Ethical approval: ? Yes ? No ? InitiatedIf Yes, provide ethical approval ID number: ________________Clinical trial registry: ? Yes ? No ? InitiatedIf Yes, provide clinical trial registry ID number: ________________Study dates: mmm-yyyy to mmm-yyyySponsor: Ministry of Health, ________________Site Monitor name: ___________________ ? Internal ? ExternalIf Site Monitor is External: ? Sponsor staff member/consultant or ? WHO staff member/consultant Please provide affiliation: ___________________STUDY SITESSite NameDrugHospitalCommunity-basedHealth centre_________________________________???_________________________________???_________________________________???_________________________________???_________________________________???_________________________________???_________________________________???_________________________________???Comments (if needed): ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________B. SITE SPECIFIC INFORMATIONSite name: ___________________ Was the site visited? ? Yes ? NoIf Yes, indicate date of visit: dd-mmm-yyyyName of site focal person: ___________________1. SITE STAFFNameQualificationsRole______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________2. TRAINING - Indicate whether the staff have received training on:YesNoN/A1Protocol requirements: target population and sample size, inclusion and exclusion criteria, definition of severe malaria, follow-up procedure, classification of outcome???2Ethical requirements and confidentiality???3Clinical assessment: physical examination, temperature, weight, height???4Test medicine and rescue medicines: dosage and administration???5Test medicine and rescue medicines: handling and storage???6List of medications that should not be used during the study period ???7Completing the screening form, case report forms, logbooks???8Microscopy procedures???9Other laboratory procedures (specify): ___________________???10Collection, handling and storage of blood slides???11Collection, handling and storage of biological samples???12Data entry procedures and analysis???13Other (specify): ___________________3. SITE FACILITIES – Indicate whether or not the following facilities exist at the site:YesNoN/A1Clinical examination room???2General laboratory???3Molecular biology laboratory???4Pharmacy or medical store ???If no pharmacy or medical store available, describe handling and storage of medicines: ____________________________________________________________________________________________________________________________________________5Office space for data management???6Is transportation available for patient follow-up?????Public transportation?Private car?Other (specify): ___________________4. STUDY DOCUMENTS – Are the following essential study documents available at the study site?YesNoN/A1Approved protocol and amendments, if any???2Approved informed consent and assent forms???3Approved translation of informed consent and assent forms???4Letters of approval from ethical committees???5Screening forms/screening logbook???6Case report forms/enrolment logbook???7Serious adverse event forms???8Laboratory register???9Drug inventory log/registry/form???10Other (specify): ___________________5. RESOURCES, MATERIAL AND SUPPLIES (CLINICAL) – Are facilities, material and supplies for clinical assessments available and in good working order?YesNoN/A1Clinical examination room (space, cleanliness)???2Stethoscopes???3Scale for children (calibrated)???4Scale for adults (calibrated)???5Thermometers (mercury or digital) and battery if electronic thermometer (calibrated)???6Medicines for the study including rescue treatment (see 6. Drug inventory)???7Syringes 2 ml, 5 ml and needles???8Sphygmomanometer (blood pressure monitor)???9Other (specify): ___________________6. Drug inventoryFormulationExpiry dateAdequate quantityStorage<30°CAntimalarialsYesNoYesNo1______________________________________mmm-yy????2______________________________________mmm-yy????3______________________________________mmm-yy????Antipyretics4______________________________________mmm-yy????5______________________________________mmm-yy????6______________________________________mmm-yy????Rescue treatment7______________________________________mmm-yy????8______________________________________mmm-yy????Other medications9______________________________________mmm-yy????10______________________________________mmm-yy????7. Resources, material and supplies (laboratory) – Are facilities, material and supplies for laboratory assessments available and in good working order?YesNoN/A1Laboratory facility room (electrical power, sink and running water)???2Work bench and stool/chair???3Microscopes and eye pieces???4Spare microscope light bulbs???5Slides???6Permanent glass pen or pencils for frosted-edge slides???7Slide storage boxes (vertical or horizontal)???8Immersion oil ???9Lancets???10Laboratory timer???11Consumables (alcohol, swabs, cotton wool)???12Biosafety (rubber gloves, protective clothes, sharp disposal box)???13Hand tally counters (at least 2)???14Giemsa???15Distilled water and buffer solution/tablets???16pH meter???17Methanol???18Drying rack???19Measuring cylinders 10 ml and 500 ml???20Funnel???21Staining jar Coplin or horizontal???22Pipettes and pipettes fillers???23Bottles and bottle screw-caps 500 ml???24Forceps???25Dropping bottle???26Glass rod???27Filter paper for PCR???28Plastic bags, desiccant and labels???29Absorbent tissue to clean the slides???30Other (specify): ___________________C. STUDY SPECIFIC INFORMATION8. ETHICSYesNoN/A1Were there any changes to the protocol????2If yes, have the changes been approved by the Institutional Review Board????3Is informed consent always obtained prior to enrolment? ???4Is the informed consent form always signed or thumb-printed, and dated by each subject????5Is the informed assent form, used for minor participants over 12 years of age, always signed or thumb-printed, and dated, where applicable????6Is the informed consent form for illiterate subjects always signed or thumb-printed, and dated, by an impartial witness????7Is consent obtained for pregnancy testing, when applicable????9. PATIENT RECRUITMENT AND FOLLOW-UPDate of recruitment of the first patient: dd-mmm-yyyyP. falciparumP. vivax (if applicable)1Number of patients screened (total)______2Number of patients enrolled (treated)______3Number of patients that completed last scheduled visit______4Number of patients lost to follow-up______5Number of patients withdrawn (other than lost to follow-up)______6Target sample size______7Is it likely that the target sample size will be achieved?? Yes ? No? Yes ? No8Was the screening log checked to review the reasons for non-inclusion?? Yes ? No? Yes ? No10. PROTOCOL COMPLIANCE AND CASE RECORD FORM (CRF) YesNoN/A1Are all CRFs complete and available????2Are the CRFs checked against source documents (screening log book, enrolment log book, laboratory register)????3Are the patients’ ID numbers and the visit dates correctly recorded????4Are there any protocol violations (i.e. erroneous inclusion, use of drug with antimalarial activity, missed visits, infection with another species)????5If yes, specify: ___________________6Is the date of birth (or age) always recorded????7Are the parasite densities at enrolment within the range of the inclusion criteria set in the protocol????8Are pregnancy tests performed at enrolment (where applicable)????9Do the study visit dates occur in accordance with the visit calendar????10Are the values for body temperature within the appropriate range (>36°C and <42°C)? ???11Is the temperature value recorded to one decimal point????12Are the study drug doses administered according to the dosing chart????13Are all doses administered under supervision????14Are blood smears and blood spots for filter papers collected according to protocol? ???15Are all blood smears and filter paper samples correctly labelled????16Do the dates in the CRFs match the corresponding dates on the blood smears and filter papers? ???17Are adverse events captured and recorded????18Is the use of concomitant medications captured and recorded????19Were there any severe adverse events (SAE)????20If yes, was the SAE form completed (Appendix 8)????21If yes, was the sponsor/WHO/pharmaceutical company notified????22Are the outcome classifications adequate clinical and parasitological response, early treatment failure, late clinical failure and late parasitological failure) accurate for each patient????23In case of treatment failure, is the correct rescue medication (and appropriate dose) given according to protocol????24Are patients withdrawn according to protocol????25Are the reasons for withdrawal provided in the CRF????26Is the drug dispensing log/registry, or any other form of drug inventory record, up to date and accurate????27How many CRFs were checked during this visit? ____ 28What percentage of the total patients enrolled does this represent? ____%29Was this a random sample????30Are all of the errors in the CRFs identified, recorded and corrected????31Other (specify): ___________________11. LABORATORY AND MICROSCOPYYesNoN/A1Is Giemsa solution correctly prepared daily????2Is the quality of blood smear staining acceptable????3Are slides kept in a slide box and stored properly????4Are any blood smears missing for any patient????5Are parasites counted as per protocol????6Is there a separate microscopy logbook for microscopist 1 and 2????7Are the final parasite counts an average of the 1st and 2nd reading????8Are blood smears read and quality controlled in accordance with the protocol (1st and 2nd readings and 3rd if needed)????9Do the parasite counts from the log/registry match the values in the CRF????10Is there an adequate supply of high quality filter-paper????11Are filter-papers properly stored, protected from light, humidity and extreme temperatures????12Are biosafety procedures followed for blood sampling????13Is the site performing any optional assessments (haematology, urine screen, G6PD, drug blood concentration sampling)????14If yes, specify: ___________________15Other (specify): ___________________12. DATA ENTRYYesNoN/A1Is the WHO data entry excel sheet for TES being used????2Is the CRF data entered by two different individuals? ???3Are data entry errors identified????D. CONCLUSIONS13. COMMENTS – In particular please comment on items from shaded or “N/A” check boxes. Please include the item number.ItemComment____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________14. ACTION ITEMSItemAction requiredPerson responsibleDue date______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy15. FOLLOW-UP ITEMS FROM LAST VISIT (IF APPLICABLE) Date of last visit: dd-mmm-yyyyItemAction requiredPerson responsibleDue date______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy______________________________________________________________________dd-mmm-yyyy dd-mmm-yyName of monitorSignatureDate ................
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