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Clinical/Safety/Product Use Management
Baseline Medical History Questions Form (Download) 2017-05-1144.48 KB
Protocol Safety Review Team (PSRT) Query Form (Download) 2017-06-0141.07 KB
Safety Labs Calculator (Download) 2017-08-0226.35 KB
Counseling Tools
Vaginal Ring Use Instructions (Download) 2017-07-17682.41 KB
HIV Pre- and Post-Test and Risk Reduction Counseling (Download) 2017-06-2264 KB
Protocol Counseling Worksheet (Download) 2017-08-2327.49 KB
Study Adherence Guidelines (Download) 2018-03-2888.95 KB
IC Support/ Factsheets
Informed Consent Coversheet (Download) 2017-07-1727.09 KB
Informed Consent Comprehension Assessment True/False Template (Download) 2017-07-1428.68 KB
Informed Consent Comprehension Assessment Open-Ended Template (Download) 2017-07-1431.7 KB
Study Brochure (Download) 2017-07-171.41 MB
Other Tools/ Templates
Avery 5267 Specimen Labels (Download) 2017-10-03230.5 KB
Eligibility Checklist (Download) 2018-04-1945.89 KB
Enrollment Behavioral Eligibility Worksheets (Download) 2017-10-1131.48 KB
Essential Documents – Suggested Filing Structure (Download) 2017-08-3129.07 KB
LDMS Tracking Sheet- Single Time Point (Download) 2017-12-07369 KB
LDMS Tracking Sheet- V2/Enrollment (Download) 2017-12-07371.58 KB
LDMS Tracking Sheet- Visit10/PUEV/ Day 91 (Download) 2017-12-07374.64 KB
Screening and Enrollment Log (Download) 2017-06-0531.91 KB
Screening Behavioral Eligibility Worksheets (Download) 2017-10-1135.26 KB
Site-Specific Clinic Study Product Accountability Log (Download) 2017-09-2529.76 KB
Small Slide Specimen Labels (Download) 2017-10-03287 KB
Source Document SOP Template (Download) 2017-09-0156.53 KB
Specimen Label Template Implementation (Download) 2017-10-03468.17 KB
Visit Calendar Tool (Download) 2017-09-0129.38 KB
CASI Manual (Download) 2017-08-28704.57 KB
In-depth interview topic guide (Download) 2018-02-19563.31 KB
Ring Comparison Tool (Download) 2018-02-192.09 MB
Regulatory/ FD Documents
DoA Log Template (Download) 2017-07-1798 KB
Financial Disclosure Form (Download) 2017-09-0621.86 KB
Financial Disclosure Form Training Slides (Download) 2017-09-06924.23 KB
Visit Checklists
Enrollment Visit Checklist (Download) 2017-08-3048.71 KB
Visit 3-7 Checklist (Download) 2017-08-3040.61 KB
Visit 8 & 9 Checklist (Download) 2017-08-3044.56 KB
PUEV / Early Termination Checklist (Download) 2017-09-2548.7 KB
Final Contact Checklist (Download) 2017-08-3042.4 KB
Pelvic Exam Checklist (Download) 2017-09-2540.34 KB
Screening Visit Checklist (Download) 2018-04-1348.08 KB