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Individual Sections
Overview of Section Contents (Download) 2015-04-22195.24 KB
Table of Contents (Download) 2015-03-1127.42 KB
Section 01: Introduction (Download) 2015-03-11145.79 KB
Section 02: Documentation Requirements (Download) 2015-03-1169.49 KB
Section 03: Participant Accrual and Retention (Download) 2015-03-11366.07 KB
Section 04: Informed Consent (Download) 2015-03-11491.29 KB
Section 05: Study Procedures (Download) 2015-04-22489.32 KB
Section 06: Counseling and Behavioral Considerations (Download) 2015-03-11170.63 KB
Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) 2015-03-111.32 MB
Section 08: Clinical Considerations (Download) 2015-03-11541 KB
Section 09: Adverse Event Reporting and Safety Monitoring (Download) 2015-03-11444.14 KB
Section 10: Laboratory Considerations (Download) 2014-10-02575.31 KB
Section 11: Data Collection (Download) 2015-03-11570.99 KB
Section 12: Data Communiques (Download) 2013-04-2210.54 KB
Section 12: Data Communiques #1 (Download) 2013-08-1265.9 KB
Section 12: Data Communiques #2 (Download) 2013-11-0555.33 KB
Section 12: Data Communiques #3 (Download) 2014-02-2125.16 KB
Section 12: Data Communiques #4 (Download) 2014-04-1831.73 KB
Section 12: Data Communiques #5 (Download) 2014-05-1229.28 KB
Section 12: Data Communiques #6 (Download) 2014-08-07155.68 KB
Section 12: Data Communiques #7 (Download) 2015-02-1726.42 KB
Section 13: Study Reporting Plan (Download) 2015-03-11169.19 KB