Microbicide Trials Network

MTN-036/IPM 047 Study Implementation Materials

Clinical/Safety/Product Use Management
Baseline Medical History Questions Form2017-May-1144.48 KB
Protocol Safety Review Team (PSRT) Query Form2017-Jun-0141.07 KB
Safety Labs Calculator2017-Aug-0226.35 KB
Counseling Tools
Vaginal Ring Use Instructions2017-Jul-17682.41 KB
HIV Pre- and Post-Test and Risk Reduction Counseling2017-Jun-2264 KB
Protocol Counseling Worksheet2017-Aug-2327.49 KB
Study Adherence Guidelines2017-Jul-2688.17 KB
IC Support/ Factsheets
Informed Consent Coversheet2017-Jul-1727.09 KB
Informed Consent Comprehension Assessment True/False Template2017-Jul-1428.68 KB
Informed Consent Comprehension Assessment Open-Ended Template2017-Jul-1431.7 KB
Study Brochure2017-Jul-171.41 MB
Other Tools/ Templates
Avery 5267 Specimen Labels2017-Oct-03230.5 KB
Eligibility Checklist2017-Aug-2346.13 KB
Enrollment Behavioral Eligibility Worksheets2017-Oct-1131.48 KB
Essential Documents – Suggested Filing Structure2017-Aug-3129.07 KB
LDMS Tracking Sheet- Single Time Point2017-Dec-07369 KB
LDMS Tracking Sheet- V2/Enrollment2017-Dec-07371.58 KB
LDMS Tracking Sheet- Visit10/PUEV/ Day 912017-Dec-07374.64 KB
Screening and Enrollment Log2017-Jun-0531.91 KB
Screening Behavioral Eligibility Worksheets2017-Oct-1135.26 KB
Site-Specific Clinic Study Product Accountability Log2017-Sep-2529.76 KB
Small Slide Specimen Labels2017-Oct-03287 KB
Source Document SOP Template2017-Sep-0156.53 KB
Specimen Label Template Implementation2017-Oct-03468.17 KB
Visit Calendar Tool2017-Sep-0129.38 KB
CASI Manual2017-Aug-28704.57 KB
Regulatory/ FD Documents
DoA Log Template2017-Jul-1798 KB
Financial Disclosure Form2017-Sep-0621.86 KB
Financial Disclosure Form Training Slides2017-Sep-06924.23 KB
Visit Checklists
Screening Visit Checklist2017-Aug-3044.31 KB
Enrollment Visit Checklist2017-Aug-3048.71 KB
Visit 3-7 Checklist2017-Aug-3040.61 KB
Visit 8 & 9 Checklist2017-Aug-3044.56 KB
PUEV / Early Termination Checklist2017-Sep-2548.7 KB
Final Contact Checklist2017-Aug-3042.4 KB
Pelvic Exam Checklist2017-Sep-2540.34 KB