Microbicide Trials Network

MTN-016 Study Implementation Materials

DescriptionDateSize
I. Sample MTN-016 Visit Checklists
MTN016 Eligibility Checklist Woman2011-Dec-1444 KB
MTN016 Eligibility Checklist Infant2011-May-3143 KB
Woman: Screening and Enrollment2009-Nov-1686.5 KB
Woman: Quarterly Visit2009-Nov-1681 KB
Woman: Interim Visit2009-Nov-1677.5 KB
Woman: Subsequent Pregnancy2009-Nov-1688.5 KB
Infant: Interim Visit2009-Nov-1680.5 KB
Infant: Newborn Visit2009-Nov-1688.5 KB
Infant: Month 1, 6, 122009-Nov-16105 KB
II. Sample MTN-016 Informed Consent Support Materials
Sample Informed Consent Comprehension Surveys2009-Nov-1657.5 KB
Sample Informed Consent Coversheet2009-Nov-1646.5 KB
Sample Informed Consent Version Control Log2009-Nov-1647.5 KB
III. Additional Forms and Worksheets
MTN-016 Major Malformation Assessment Worksheet2009-Nov-1639 KB
MTN-016 Major Malformation Assessment Form2009-Nov-1633 KB
MTN-016 Gestational Age Worksheet2009-Nov-1622 KB
MTN-016 INFANT Enrollment Log2010-Jun-0962.5 KB
New Ballard GA Assessment Source Document2011-May-2388.5 KB
FOR US SITES ONLY: Female Growth Chart2011-Dec-01679.45 KB
FOR US SITES ONLY: Male Growth Chart2011-Dec-01722.54 KB
Infant Scale Calibration2012-Jan-1762 KB
MTN-016 Infant Physical Exam Checklist2011-Mar-02163 KB
MTN-016 Staff Guide for Explaining Conditions on GSH-1 CRF2010-Sep-21298.03 KB
MTN-016 Study Cheat Sheet2010-Jun-08179.06 KB
MTN-016 Visit Calendar Tool v1.02011-Apr-1441.5 KB
MTN-016 WOMEN Screening and Enrollment Log2010-Jun-0864 KB
IV. MTN-016 Template SOPs
Eligibility Determination2010-Jul-1981 KB
Infant HIV Testing2010-Jul-1995.5 KB
Infant Referral2010-Jul-1969.5 KB
IRB-EC Communication2010-Jul-1981.5 KB
Obtaining Informed Consent2010-Jul-1990.5 KB
Participant Accrual2010-Jul-19135 KB
Participant Retention2010-Jul-1981.5 KB
Photographing of Infants2010-Jul-1966.5 KB
Source Documentation2010-Jul-19118.5 KB
V. Operational Reminders
Operational Reminder Memo2011-Dec-1431.96 KB
VI. Other
Study Communication Contact Sheet2011-May-2319.44 KB