Individual Sections| Table of Contents – Current Sections (Download) | 2018-08-31 | 63.54 KB |
| Overview and Control Document – Version History and Notice of Changes (Download) | 2018-08-31 | 163.22 KB |
| Section 01: Introduction (Download) | 2018-08-31 | 161.47 KB |
| Section 02: Documentation Requirements (Download) | 2018-08-31 | 236.67 KB |
| Section 03: Accrual, Eligibility Determination, & Study Procedures (Download) | 2018-08-31 | 263.53 KB |
| Section 04: Informed Consent (Download) | 2018-08-31 | 225.31 KB |
| Section 05: Safety and Counseling Considerations (Download) | 2018-08-31 | 165.86 KB |
| Section 06: Data Management (Download) | 2018-08-31 | 1014.65 KB |
| Section 07: Data Communiques (Download) | 2018-08-31 | 213.73 KB |
| Section 07: Data Communiqué #1 (Download) | 2018-06-26 | 377.7 KB |
| Section 07: Data Communiqué #2 (Download) | 2018-07-03 | 286.68 KB |
| Section 07: Data Communiqué #3 (Download) | 2018-07-30 | 312.98 KB |
