SSP SectionsOverview of Section Contents (Download) | 2015-02-13 | 147.06 KB |
Section 01: Introduction (Download) | 2014-07-31 | 26.53 KB |
Section 02: Protocol (Download) | 2014-01-31 | 13.02 KB |
Section 03: Documentation Requirements (Download) | 2015-02-13 | 416.42 KB |
Section 04: Participant Accrual, Screening and Enrollment (Download) | 2013-07-31 | 787.53 KB |
Section 05: Informed Consent (Download) | 2014-01-31 | 311.08 KB |
Section 06: Participant Follow-up (Download) | 2015-02-13 | 564.76 KB |
Section 07: Visit Checklists (Download) | 2015-02-13 | 182.81 KB |
Section 08: Participant Retention (Download) | 2014-01-31 | 45.74 KB |
Section 09: Study Product Considerations for Non-Pharmacy Staff (Download) | 2015-02-13 | 788.43 KB |
Section 10: Clinical Considerations (Download) | 2015-02-13 | 670.12 KB |
Section 11: Adverse Event Reporting and Safety Monitoring (Download) | 2015-02-13 | 517.71 KB |
Section 12: Counseling Considerations (Download) | 2015-02-13 | 1.08 MB |
Section 13. Laboratory Considerations (Download) | 2014-07-31 | 627.32 KB |
Section 14: Data Collection (Download) | 2015-02-13 | 756.37 KB |
Section 15: Data Communiques (Download) | 2012-07-17 | 52.36 KB |
Section 15: Data Communiques #1 (Download) | 2012-09-18 | 163.86 KB |
Section 15: Data Communiques #2 (Download) | 2012-09-24 | 17.61 KB |
Section 15: Data Communiques #3 (Download) | 2012-10-29 | 20.13 KB |
Section 15: Data Communiques #4 (Download) | 2012-11-20 | 40.23 KB |
Section 15: Data Communiques #5 (Download) | 2012-12-21 | 43.3 KB |
Section 15: Data Communiques #6 (Download) | 2013-02-22 | 195.26 KB |
Section 15: Data Communiques #7 (Download) | 2013-03-12 | 179.95 KB |
Section 15: Data Communiques #8 (Download) | 2013-05-10 | 103.7 KB |
Section 15: Data Communiques #9 (Download) | 2013-08-05 | 94.57 KB |
Section 15: Data Communiques #10 (Download) | 2013-10-25 | 118.74 KB |
Section 15: Data Communiques #11 (Download) | 2014-03-12 | 84.42 KB |
Section 15: Data Communiques #12 (Download) | 2014-08-08 | 37.19 KB |
Section 15: Data Communiques #13 (Download) | 2014-11-18 | 168.73 KB |
Section 15: Data Communiques #14 (Download) | 2015-02-04 | 132.56 KB |
Section 15: Data Communiques #15 (Download) | 2015-02-25 | 132.47 KB |
Section 15: Data Communiques #16 (Download) | 2015-03-31 | 142.58 KB |
Section 15: Data Communiques #17 (Download) | 2015-05-22 | 134.35 KB |
Section 15: Data Communiques #18 (Download) | 2016-02-01 | 27.14 KB |
Section 16: ACASI User Manual (Download) | 2015-02-13 | 2.01 MB |
Section 17: Study Reporting Plan (Download) | 2015-02-13 | 151.38 KB |
Section 18: ASPIRE Qualitative Component (Download) | 2015-02-13 | 636.91 KB |