Baseline Medical History Log CRF (all baseline conditions including clinical evaluations will be summarized here) Adverse Event Log CRF (all follow-up conditions including abnormal findings from clinical evaluations will be documented on this CRF) Chart notes Source documentation for participant reported medical/menstrual Medical and menstrual history history: Baseline Medical History Questions Baseline Medical History Log CRF Pregnancy Report and Pregnancy History CRFs (source if relevant medical records are not available) Pregnancy Outcome Log CRF (source if relevant medical records are not available) notes Concomitant medications Concomitant Medications Log CRF Vital Signs CRF Physical examination (full or targeted) Physical Exam CRF Pelvic Exam Diagrams Pelvic exam Pelvic Exam CRF Pelvic Exam checklist Disclose available test results Chart notes and/or visit checklist Adverse Event Log CRF Record/update AEs (and/or Chart notes) Treat or prescribe treatment for UTIs/RTIs/STIs or refer for Chart notes and/or prescription other findings Referral Letter LABORATORY Lab Requisition form, LDMS Specimen Tracking Sheet, or Specimen Collection Times Specimen Collection CRF Site-specific lab requisition form hCG Site testing log/results report Site-specific lab requisition form Urine dipstick/culture Lab results report Site-specific lab requisition form Site testing log/results report (rapids, Geenius confirmatory HIV-1 testing testing) Lab result report (HIV RNA) Site-specific lab requisition form, chart note, or visit checklist Plasma (archive) Specimen Collection CRF Site-specific lab requisition form Chemistries (AST and ALT) Lab results report Site-specific lab requisition form CBC with platelets and differential Lab results report Site-specific lab requisition form Syphilis serology Lab results report Site-specific lab requisition form, LDMS Specimen Tracking DPV levels (blood) Sheet, chart note, or visit checklist Specimen Collection CRF Site-specific lab requisition form NAAT for GC/CT and trichomonas Lab results report Site-specific lab requisition form Pap interpretation Lab results report
Medical and menstrual history Baseline Medical History Log CRF (all baseline conditions including clinical evaluations will be summarized here) Adverse Event Log CRF (all follow-up conditions including abnormal findings from clinical evaluations will be documented on this CRF) Chart notes Source documentation for participant reported medical/menstrual history: Baseline Medical History Questions Baseline Medical History Log CRF Pregnancy Report and Pregnancy History CRFs (source if relevant medical records are not available) Pregnancy Outcome Log CRF (source if relevant medical records are not available) notes Concomitant medications Concomitant Medications Log CRF Physical examination (full or targeted) Vital Signs CRF Physical Exam CRF Pelvic exam Pelvic Exam Diagrams Pelvic Exam CRF Pelvic Exam checklist Disclose available test results Chart notes and/or visit checklist Record/update AEs Adverse Event Log CRF (and/or Chart notes) Treat or prescribe treatment for UTIs/RTIs/STIs or refer for other findings Chart notes and/or prescription Referral Letter LABORATORY Specimen Collection Times Lab Requisition form, LDMS Specimen Tracking Sheet, or Specimen Collection CRF hCG Site-specific lab requisition form Site testing log/results report Urine dipstick/culture Site-specific lab requisition form Lab results report HIV-1 testing Site-specific lab requisition form Site testing log/results report (rapids, Geenius confirmatory testing) Lab result report (HIV RNA) Plasma (archive) Site-specific lab requisition form, chart note, or visit checklist Specimen Collection CRF Chemistries (AST and ALT) Site-specific lab requisition form Lab results report CBC with platelets and differential Site-specific lab requisition form Lab results report Syphilis serology Site-specific lab requisition form Lab results report DPV levels (blood) Site-specific lab requisition form, LDMS Specimen Tracking Sheet, chart note, or visit checklist Specimen Collection CRF NAAT for GC/CT and trichomonas Site-specific lab requisition form Lab results report Pap interpretation Site-specific lab requisition form Lab results report
MTN_036_Source%20Doc%20SOP%20Template2.docx