Category Legend

Study Type(s)

Topic Area(s)

Document Type(s)

Study Method(s)

Document Method(s)

TRAX: Parent or Legal Guardian Informed Consent Form (1260)

Parent or legal guardian informed consent form for children participating in TRAX study.

TRAX: Adolescent Assent Form (1259)

TRAX study participants 7 years or older assent form.

TRAX: Adult Informed Consent Form (1258)

TRAX study adult participant informed consent form.

TRAX: Protocol (1257)

Post-exposure protocol for TRAX study staff.

TRAX: Needle Stick Injury and HIV Post Exposure SOP (1256)

Post exposure protocol for TRAX study staff.

TRAX: Source Documentation SOP (1255)

Source documentation protocol for TRAX study staff.

TRAX: Temperature Monitoring, Maintenance and Servicing SOP (1254)

Specimen freezer temperature monitoring protocol for TRAX study.

TRAX: Patient Location Determination SOP (1253)

Post-enrollment TRAX study participants location determination.

TRAX: Communication Plan SOP (1252)

TRAX staff protocol for clear communication during study period.

TRAX: Temperature Monitoring and Evaluation SOP (1251)

Refrigerator temperature monitoring protocol for TRAX study staff.

TRAX: Participant Reimbursement Version 1 Dec 2011 SOP (1250)

Reimbursement protocol for TRAX study staff.

TRAX: Obtaining Informed Consent (Adult and Child) SOP (1249)

Protocol to obtain consent from adults or children in TRAX study.

TRAX: JNB Preparation of Isolates and Storage SOP (1248)

TRAX study laboratory method reference in mycobacterial isolate storage and transfer.

TRAX: Serious Adverse and Adverse Events SOP (1247)

Documentation procedure of serious adverse events and adverse events of TRAX study participants.

TRAX: Collecting GPS Coordinates SOP (1246)

Protocol to find TRAX study participants using GPS device.

TRAX: HIV Counseling, Testing and Reporting of Results SOP (1245)

TRAX study participant counseling pre and post HIV Rapid testing.

TRAX: Archiving Study Documents SOP (1244)

Post-TRAX study document archiving protocol.

TRAX: Infection Control SOP (1243)

Prevention of XDR TB spread to TRAX staff.

TRAX: Assigning Study Enrollment ID SOP (1242)

TRAX study staff study participants ID assignment protocol.

TRAX: Patient Interview SOP (1241)

TRAX study staff participant interview administration standardization protocol.

TRAX: Isolate Retrieval and Packaging SOP (1240)

Facility transfer procedure for identified XDR TB isolates for TRAX staff.

TRAX: Medical Records Review SOP (1239)

Medical records extraction protocol for TRAX study staff.

TRAX: Blood Sample Collection & Transportation SOP (1238)

Procedure for protocol deviations of TRAX study.

TRAX: Protocol Deviations SOP (1237)

Procedure for protocol deviations of TRAX study.

TRAX: Receiving Mtb Isolates at PHRI from South Africa SOP (1236)

TRAX study PHRI procedure for receiving Mtb isolates from South Africa.

TRAX: IALCH Lab Technician Daily Report SOP (1235)

Local hospital lab verification protocol for TRAX study participants.

TRAX: Participant Reimbursement Version 2 July 2014 SOP (1234)

Participant reimbursement protocol for TRAX study.

TRAX: Site Visits & Monitoring SOP (1233)

Monitoring site visits procedure for Emory RSPH staff in TRAX study.

TRAX: Sputum Collection & Transportation SOP (1232)

Sputum collection and transportation TRAX study staff protocol.

TRAX: Data Quality & Management Plan SOP (1231)

Data collection and management TRAX staff protocol.

TRAX: Culture of Mtb & Waste Management SOP (1230)

Mycobacteria tuberculosis storage and waste management protocol for TRAX staff.

TRAX: Blood Storage SOP (1229)

TRAX staff protocol for blood and sputum storage including; safety precautions, specimen handling, and equipment needed.

TRAX: Social Network Questionnaire CRF (1228)

Prior eligibility screening potential TRAX participants including; XDR TB lab results, current XDR TB treatment, located in past three attempts.

TRAX: PreScreening CRF (1227)

Prior eligibility screening potential TRAX participants including XDR TB lab results, current XDR TB treatment, located in past three attempts.

TRAX: Patient Interview Form (1226)

TRAX study staff form for interviewing participants on; sociodemographic information, substance use, alcohol use, smoking history, TB symptoms in the past six months, past medical history, HIV diagnosis, HIV testing and specimen collection.

TRAX: Patient Locator CRF (1225)

Participant’s current address with emergency contact, employment and treatment supervisor for TRAX.

TRAX: Chart Abstraction CRF (1224)

TRAX staff medical records form including; admissions, hospital name, chest x-ray results, HIV diagnosis and results, TB hospital admission history, TB drug resistance history and current status, diabetes, TB history, medication history prior to diagnostic collection, viral load and CD4 count.

TRAX: Alternate CD4 Viral Load Lab Results CRF (1223)

TRAX participant lab results including: CD4 count and viral load.

TRAX: Screening CRF (1222)

Participant initial TRAX screening form including; exclusion and inclusion criteria.

TRAX: Home Visit CRF (1221)

TRAX participant primary residence home visit form.

TRAX: Diagnostic TB Culture DST Results CRF (1220)

Participant TB culture and DST results including: sputum collection, smear results, culture results, drug susceptibility testing (DST) results, interpretation for TRAX records.

TRAX: Baseline Auramine Results CRF (1218)

Participant stain results including: date of sputum collection and auramine stain results for TRAX.

TRAX: Study Activities Checklist CRF (1217)

Participant activity tracking log for TRAX including; screening, enrollment via a patient visit, enrollment after the patient visit.

TRAX: Social Network Questionnaire Tables CRF (1216)

Participant’s location questionnaire table; places of residence, location and contacts at places of work, locations at hospitals, other congregate locations and contacts for TRAX.

TRAX: Specimen Transfer CRF (1215)

Specimen transfer form to be completed by dispatch, transport, and laboratory staff for TRAX.