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Clinical/Safety Management
Rectal Terms MedDRA (Download) 2018-01-0823.47 KB
Counseling Tools/Worksheets
HIV Pre/Post Test and Risk Reduction Counseling Worksheet (Download) 2018-02-0629.9 KB
Protocol Counseling Worksheet (Download) 2017-12-0832.94 KB
Financial Disclosure
Financial Disclosure Form (Download) 2016-05-0324.67 KB
Financial Disclosure Form Training Slides (Download) 2016-04-29495.58 KB
Informed Consent Support Materials
Informed Consent Comprehension Assessment (Open-Ended Template) (Download) 2018-02-0132.5 KB
Sample Informed Consent Coversheet (Download) 2018-02-0127.91 KB
Other Tools/Templates
Avery 5267 Specimen Labels (Download) 2018-02-01222.5 KB
Baseline Medical History Questions Guide (Download) 2018-02-1630.28 KB
Clinic Instructions and Record for Measuring Coital Simulation Device Gel Dose (Download) 2018-03-1530.33 KB
DoA Staff Roster (Download) 2018-02-0742.52 KB
Eligibility Checklist (Download) 2018-02-0639.88 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2018-02-0630.76 KB
Participant Instructions for use of Coital Simulation Device (Dildo) and Dapivirine Gel (Download) 2018-02-1223.53 KB
Product Use Instructions (Download) 2018-02-07474.04 KB
Screening and Enrollment Log (Download) 2018-02-0735.5 KB
Screening Behavioral Eligibility Worksheet (Download) 2018-02-0630.35 KB
Specimen Label Template Implementation Requirements, Installation, and Use (Download) 2018-02-01468.17 KB
Visit Calendar Tool (Download) 2018-03-1217.9 KB
SOP Templates
Source Documentation SOP (Download) 2018-02-14111.19 KB
Study Specific Protocol Training (Download) 2018-03-025.34 MB
Visit Checklists
Enrollment Visit Checklist (Download) 2018-02-2342.89 KB
Rectal Exam Checklist (Download) 2018-02-2342.59 KB
Screening Visit Checklist (Download) 2018-02-2344.4 KB
Termination Visit/Contact Checklist (Download) 2018-02-2336 KB
Visit 3 (Period 1) and Visit 5 (Period 2) Dosing Visits Checklist (Download) 2018-02-2350.81 KB
Visit 4 (Sampling) and Visit 6 (Sampling/Early Termination) Checklist (Download) 2018-02-2347.9 KB