MTN-016 Study Implementation Materials

I. Sample MTN-016 Visit Checklists
MTN-016 Eligibility Checklist Template Woman (Download) 2012-01-1544.5 KB
MTN-016 Eligibility Checklist Infant (Download) 2011-05-3143 KB
Woman: Screening and Enrollment v2.0 (Download) 2014-04-0180.5 KB
Woman: Quarterly Visit (Download) 2009-11-1681 KB
Woman: Interim Visit (Download) 2009-11-1677.5 KB
Woman: Subsequent Pregnancy v2.0 (Download) 2014-04-0184.5 KB
Infant: Interim Visit v2.0 (Download) 2014-04-0179 KB
Infant: Newborn Initial Visit v2.0 (Download) 2014-04-0183 KB
Infant: Month 1, 6, 12 v2.0 (Download) 2014-04-0182.5 KB
II. Sample MTN-016 Informed Consent Support Materials
Sample Informed Consent Comprehension Surveys (Download) 2014-08-0569 KB
Sample Informed Consent Coversheet for MTN-016 (Download) 2014-08-2914.33 KB
III. Additional Forms and Worksheets
02: Visit Calendar Tool v2.0 (Download) 2014-02-0756 KB
03: Staff Guide for Explaining Conditions on GSH-1 CRF (Download) 2010-09-22298.03 KB
04: Unique Strategies for Retaining a Unique Population Within the EMRACE Trial (Download) 2012-10-0448.63 KB
05: WOMEN Screening and Enrollment Log (Download) 2010-06-0964 KB
06: INFANT Enrollment Log (Download) 2010-06-0962.5 KB
07: Major Malformation Assessment Worksheet (Download) 2009-11-1639 KB
08: Major Malformation Assessment Form (Download) 2009-11-1633 KB
09: Gestational Age Worksheet (Download) 2012-11-2034 KB
11: Using Infant Growth Charts (Download) 2012-10-091.35 MB
12: Female Growth Chart (Download) 2011-12-01679.45 KB
13: Male Growth Chart (Download) 2011-12-01722.54 KB
14: Infant Scale Calibration (Download) 2012-01-1762 KB
15: LDMS Specimen Tracking Sheet (Download) 2012-08-0872.14 KB
IV. MTN-016 Template SOPs
Eligibility Determination (Download) 2010-07-2081 KB
Infant HIV Testing (Download) 2010-07-2095.5 KB
Infant Referral (Download) 2010-07-2069.5 KB
IRB-EC Communication (Download) 2010-07-2081.5 KB
Obtaining Informed Consent (Download) 2010-07-2090.5 KB
Participant Accrual (Download) 2010-07-20135 KB
Participant Retention (Download) 2010-07-2081.5 KB
Photographing of Infants (Download) 2010-07-2066.5 KB
Source Documentation, v2.0 (Download) 2014-07-30104 KB
V. Other
Study Communication Contact Sheet (Download) 2011-05-2319.44 KB

Source URL: