TRAX: Parent or Legal Guardian Informed Consent Form (1260)
Parent or legal guardian informed consent form for children participating in TRAX study.
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Study Type(s)
Topic Area(s)
Document Type(s)
Study Method(s)
Document Method(s)
Parent or legal guardian informed consent form for children participating in TRAX study.
TRAX study participants 7 years or older assent form.
TRAX study adult participant informed consent form.
Post-exposure protocol for TRAX study staff.
Post exposure protocol for TRAX study staff.
Source documentation protocol for TRAX study staff.
Specimen freezer temperature monitoring protocol for TRAX study.
Post-enrollment TRAX study participants location determination.
TRAX staff protocol for clear communication during study period.
Refrigerator temperature monitoring protocol for TRAX study staff.
Reimbursement protocol for TRAX study staff.
Protocol to obtain consent from adults or children in TRAX study.
TRAX study laboratory method reference in mycobacterial isolate storage and transfer.
Documentation procedure of serious adverse events and adverse events of TRAX study participants.
Protocol to find TRAX study participants using GPS device.
TRAX study participant counseling pre and post HIV Rapid testing.
Post-TRAX study document archiving protocol.
Prevention of XDR TB spread to TRAX staff.
TRAX study staff study participants ID assignment protocol.
TRAX study staff participant interview administration standardization protocol.
Facility transfer procedure for identified XDR TB isolates for TRAX staff.
Medical records extraction protocol for TRAX study staff.
Procedure for protocol deviations of TRAX study.
Procedure for protocol deviations of TRAX study.
TRAX study PHRI procedure for receiving Mtb isolates from South Africa.
Local hospital lab verification protocol for TRAX study participants.
Participant reimbursement protocol for TRAX study.
Monitoring site visits procedure for Emory RSPH staff in TRAX study.
Sputum collection and transportation TRAX study staff protocol.
Data collection and management TRAX staff protocol.
Mycobacteria tuberculosis storage and waste management protocol for TRAX staff.
TRAX staff protocol for blood and sputum storage including; safety precautions, specimen handling, and equipment needed.
Prior eligibility screening potential TRAX participants including; XDR TB lab results, current XDR TB treatment, located in past three attempts.
Prior eligibility screening potential TRAX participants including XDR TB lab results, current XDR TB treatment, located in past three attempts.
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.
Participant’s current address with emergency contact, employment and treatment supervisor for TRAX.
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 participant lab results including: CD4 count and viral load.
Participant initial TRAX screening form including; exclusion and inclusion criteria.
TRAX participant primary residence home visit form.
Participant TB culture and DST results including: sputum collection, smear results, culture results, drug susceptibility testing (DST) results, interpretation for TRAX records.
Hospital key for TRAX.
Participant stain results including: date of sputum collection and auramine stain results for TRAX.
Participant activity tracking log for TRAX including; screening, enrollment via a patient visit, enrollment after the patient visit.
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.
Specimen transfer form to be completed by dispatch, transport, and laboratory staff for TRAX.