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DescriptionDateSize
Behavioral Assessments
Baseline CASI (Download) 2019-08-26492.11 KB
Follow-Up Visit 4 CASI (Download) 2019-08-19128.6 KB
Follow-Up Visit 8 CASI (Download) 2019-08-26212.66 KB
IDI Exit Interview (Download) 2019-08-26255.73 KB
Clinical/Safety Management
Baseline Medical History Guide (Download) 2019-09-0429.86 KB
Counseling Tools
HIV/STI Counseling Worksheet (Download) 2019-08-02210.2 KB
Protocol Counseling Worksheet (Download) 2019-10-2534.48 KB
Informed Consent Support Materials
Informed Consent Comprehension Assessment (open ended) (Download) 2019-08-0229.46 KB
Informed Consent Comprehension Assessment (T/F) (Download) 2019-08-0232.47 KB
Informed Consent Coversheet (Download) 2019-08-0226.49 KB
Other Tools/Templates
AVERY L7656 labels or equivalent (for A4 paper) (Download) 2019-10-10281.5 KB
Draft CRFs (Download) 2019-08-08514.32 KB
Eligibility Checklist (Download) 2019-10-0141.26 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2019-10-0131.47 KB
Rectal Insert Guide (Download) 2019-08-02116.62 KB
Saline Enema for Home Use Instructions (Download) 2019-06-05109.28 KB
Screening and Enrollment Log (Download) 2019-10-0128.62 KB
Screening Behavioral Eligibility Worksheet (Download) 2019-10-0132.31 KB
Small Slide Labels or equivalent (for 8.5”x11” paper) (Download) 2019-10-10369.5 KB
Specimen Label Template Implementation Requirements, Installation, and Use (Download) 2019-10-10468.17 KB
Visit Calendar Tool (Download) 2019-11-0423.62 KB
Regulatory/FD Documents
Financial Disclosure Form (Download) 2019-08-0254.5 KB
Financial Disclosure Form for Protocol Chair (Download) 2019-08-0254.9 KB
SOP Templates
Source Documentation SOP Template (Download) 2019-10-0350.64 KB
Visit Checklists
24-hour Post-Dosing Visit (Visits 4 and 8) (Download) 2019-10-0138.62 KB
48-hour Post-Dosing Visit (Visits 5 and 9) (Download) 2019-10-0137.77 KB
72-hour Post-Dosing Visit (Visits 6 and 10) (Download) 2019-10-0142.13 KB
Dosing Visit (Visits 3 and 7) Checklist (Download) 2019-10-0139.57 KB
Enrollment Visit Checklist (Download) 2019-10-0143.16 KB
Final Contact (Visit 11)/Early Termination Checklist (Download) 2019-10-0135.93 KB
Genital Exam Checklist (Group 1) (Download) 2019-10-2836.31 KB
Genital Exam Checklist (Group 2) (Download) 2019-10-2834.89 KB
Screening Visit Checklist (Download) 2019-10-0142.46 KB