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 Clinical Manual of Procedures   (Documents are PDFs)

  Manual of Procedures
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 Chapter & Description
0 Table of Contents
1 Trial Policies
2 Publications
3 Trial Communications
4 Human Subjects
5 Recruitment
6 Prescreening Visit
7 Screening Visit 1 (SV1)
8 Screening Visit 2 (SV2)
9 Screening Visit 3 (SV3)
10 Interim Period Measures
11 Randomization/Intervention Visit (R/I)
12 3 Month FU Visit
13 6 Month FU Visit
14 12 Month FU Visit
15 18 Month Visit
16 Participant Closeout
17 Blood Pressure Assessment
18 Fitness Assessment
19 24-Hour Food Interviews
20 Other Clinical Measures
21 Central Laboratory Procedures
22 Physical Activity Assessment
23 Safety Monitoring
24 Study Outcomes and Adjudication
25 Data Management
26 Trial Monitoring Reports
27 Offsite Data Collection Visits
28 Priorities for Collecting Follow-up Measurements 

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