Microbicide Trials Network

MTN-016 Study Implementation Materials

I. Sample MTN-016 Visit Checklists
MTN-016 Eligibility Checklist Template Woman2012-Jan-1544.5 KB
MTN-016 Eligibility Checklist Infant2011-May-3143 KB
Woman: Screening and Enrollment v2.02014-Apr-0180.5 KB
Woman: Quarterly Visit2009-Nov-1681 KB
Woman: Interim Visit2009-Nov-1677.5 KB
Woman: Subsequent Pregnancy v2.02014-Apr-0184.5 KB
Infant: Interim Visit v2.02014-Apr-0179 KB
Infant: Newborn Initial Visit v2.02014-Apr-0183 KB
Infant: Month 1, 6, 12 v2.02014-Apr-0182.5 KB
II. Sample MTN-016 Informed Consent Support Materials
Sample Informed Consent Comprehension Surveys2014-Aug-0569 KB
Sample Informed Consent Coversheet for MTN-0162014-Aug-2914.33 KB
III. Additional Forms and Worksheets
02: Visit Calendar Tool v2.02014-Feb-0756 KB
03: Staff Guide for Explaining Conditions on GSH-1 CRF2010-Sep-22298.03 KB
04: Unique Strategies for Retaining a Unique Population Within the EMRACE Trial2012-Oct-0448.63 KB
05: WOMEN Screening and Enrollment Log2010-Jun-0964 KB
06: INFANT Enrollment Log2010-Jun-0962.5 KB
07: Major Malformation Assessment Worksheet2009-Nov-1639 KB
08: Major Malformation Assessment Form2009-Nov-1633 KB
09: Gestational Age Worksheet2012-Nov-2034 KB
11: Using Infant Growth Charts2012-Oct-091.35 MB
12: Female Growth Chart2011-Dec-01679.45 KB
13: Male Growth Chart2011-Dec-01722.54 KB
14: Infant Scale Calibration2012-Jan-1762 KB
15: LDMS Specimen Tracking Sheet2012-Aug-0872.14 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 Documentation, v2.02014-Jul-30104 KB
V. Other
Study Communication Contact Sheet2011-May-2319.44 KB