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DescriptionDateSize
Behavioral Assessments
Baseline Behavioral CASI (Download) 2018-09-04526.79 KB
Conjoint Analysis Survey (Download) 2018-10-04136.8 KB
Final Visit In-Depth Interview (Download) 2018-09-04129.08 KB
PUEV Douche Behavioral CASI (Download) 2018-09-04531.57 KB
PUEV Douche In-Depth Interview (Download) 2018-09-04137.82 KB
PUEV Insert Behavioral CASI (Download) 2018-09-04531.59 KB
PUEV Insert In-Depth Interview (Download) 2018-09-04121.82 KB
PUEV Suppository Behavioral CASI (Download) 2018-09-04531.72 KB
PUEV Suppository In-Depth Interview (Download) 2018-09-04123.74 KB
Short Message Service (SMS) Script for Daily Reporting (Download) 2019-02-18658.44 KB
SMS Assistance Manual (Download) 2019-03-22981.9 KB
Clinical/Safety Management
AE Text Guidance (Download) 2019-03-07127.6 KB
Baseline Medical History Guide (Download) 2018-12-0328.22 KB
Protocol Requirements for Product Holds/Discontinuations (Download) 2018-09-18227.07 KB
Protocol Safety Review Team Query Form (Download) 2018-08-2440.06 KB
Counseling Tools
HIV Counseling Worksheet (Download) 2018-08-2261.5 KB
Protocol Counseling Worksheet (Download) 2018-08-2230.37 KB
Informed Consent Support Materials
Informed Consent Comprehension Assessment (Open-Ended) (Download) 2018-07-2533.86 KB
Informed Consent Coversheet (Download) 2018-07-2528.3 KB
Other Tools/Templates
Avery 5267 Specimen Labels (Download) 2018-09-28281.5 KB
Eligibility Checklist (Download) 2018-07-2337.53 KB
Enrollment Behavioral Eligibility Worksheet (Download) 2018-07-2330.17 KB
Factsheet Booklet (Download) 2018-10-22805.15 KB
LDMS Specimen Tracking Sheet (Download) 2019-01-16321.03 KB
Placebo Rectal Douche Instructions (Download) 2019-01-22536.69 KB
Placebo Rectal Insert Instructions (Download) 2019-01-22521.41 KB
Placebo Rectal Suppository Instructions (Download) 2018-10-31400.54 KB
Screening and Enrollment Log (Download) 2018-08-2234.35 KB
Screening Behavioral Eligibility Worksheet (Download) 2018-07-2331.71 KB
Specimen Label Template Implementation (Download) 2018-09-28468.17 KB
Study Staff Delegation of Duties (DoD) and Signature Key/Staff Roster (Download) 2018-08-1642.58 KB
Visit Calendar Tool (Download) 2019-05-0924.71 KB
Regulatory/FD Documents
Financial Disclosure Form (Download) 2019-03-2554.01 KB
Financial Disclosure Form - Protocol Chair (Download) 2019-03-2554.86 KB
Financial Disclosure Form - Training Slides (Download) 2018-06-26915.46 KB
SOP Templates
Data Management SOP Template (Download) 2018-08-28215.5 KB
Source Documentation SOP (Download) 2018-09-07110.62 KB
Visit Checklists
Anorectal Exam Checklist (Download) 2019-05-1330.78 KB
Enrollment Visit Checklist (Download) 2019-05-0343.93 KB
Final Visit/Early Termination Checklist (Download) 2018-09-1438.31 KB
Genital Exam Checklist (Download) 2018-09-1428.8 KB
Interim Visit Checklist (Download) 2018-09-1431.83 KB
Pelvic Exam Checklist (Download) 2018-09-1430.3 KB
Product Switch Visit (Visits 4 and 6) Checklist (Download) 2018-09-1437.01 KB
Product Use End Visits (Visits 3, 5, or 7) Checklist (Download) 2018-09-1437.31 KB
Screening Visit Checklist (Download) 2018-09-1441.92 KB