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Counseling Tools/Worksheets
HIV Pre/Post Test and Risk Reduction Counseling Worksheet (Download) 2018-09-1060.5 KB
Protocol Counseling Worksheet (Download) 2018-09-1029.89 KB
Study Adherence Guidelines (Download) 2018-12-0682.79 KB
IC Support/Factsheets/Education
Informed Consent Comprehension Assessment (OPEN ENDED) (Download) 2018-09-1931.63 KB
Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) 2018-09-1928.78 KB
Informed Consent Coversheet (Download) 2018-09-1926.88 KB
Other Tools/Templates
Avery 5267 Specimen Labels (Download) 2019-01-03285.5 KB
Baseline Medical History Guide (Download) 2018-09-1031.57 KB
Calculated Creatinine Clearance Worksheet (Download) 2019-02-1947.5 KB
Data Management SOP (Download) 2018-11-02128.48 KB
Eligibility Checklist (Download) 2018-10-2345.09 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2018-09-1031.46 KB
MTN-038 Operational Guidance #1: Revised Product Use Instructions and Important Information (Download) 2019-05-08483.56 KB
Participant Visit Calculator (Download) 2018-11-0621.57 KB
Screening and Enrollment Log (Download) 2018-10-2334.82 KB
Screening Behavioral Eligibility Worksheet (Download) 2018-09-2235.08 KB
Site-Specific Clinic Study Product Accountability Log (Download) 2018-08-2033.77 KB
Small Slide Specimen Labels (Download) 2019-01-03375 KB
Source Documentation SOP (Download) 2018-10-2959.91 KB
Specimen Label Template Implementation Requirements, Installation, and Use (Download) 2019-01-03468.17 KB
Vaginal Ring Insertion Instructions (Download) 2019-05-03645.03 KB
In-depth interview topic guide (Download) 2018-08-161.03 MB
Ring Comparison Tool (Download) 2018-08-16498.09 KB
Regulatory/FD Documents
Delegation of Authorities Log (Download) 2018-09-1997.5 KB
Financial Disclosure Form (Download) 2019-03-2554.77 KB
Financial Disclosure Form Training Slides (Download) 2018-09-191.04 MB
Safety/Clinical/Product Use Management
Protocol Safety Review Team Query Form (Download) 2018-01-3144.25 KB
Visit Checklists
Enrollment Visit Checklist (Download) 2018-10-1253.08 KB
Pelvic Exam Checklist (Download) 2018-10-2238.41 KB
Screening Visit Checklist (Download) 2018-10-2248.73 KB
Visit 10 Final Contact (Day 92-94) Checklist (Download) 2018-10-1240.1 KB
Visit 6, 7 & 8 (Day 28/Week 4, Day 42/Week 6, Day 56/Week 8) Checklist (Download) 2018-10-2243.66 KB
Visit 9 (PUEV/Early Termination – Day 91/Week 13) Checklist (Download) 2018-10-2248.82 KB
Visits 3-5 (Day 1, 7 & 14) Checklist (Download) 2018-10-1240.64 KB