Back to top
DescriptionDateSize
Individual Sections
Table of Contents - Current Sections (Download) 2018-08-3163.54 KB
Overview and Control Document - Version History and Notice of Changes (Download) 2018-08-31163.22 KB
Section 01: Introduction (Download) 2018-08-31161.47 KB
Section 02: Documentation Requirements (Download) 2018-08-31236.67 KB
Section 03: Accrual, Eligibility Determination, & Study Procedures (Download) 2018-08-31263.53 KB
Section 04: Informed Consent (Download) 2018-08-31225.31 KB
Section 05: Safety and Counseling Considerations (Download) 2018-08-31165.86 KB
Section 06: Data Management (Download) 2018-08-311014.65 KB
Section 07: Data Communiques (Download) 2018-08-31213.73 KB
Section 07: Data Communiqué #1 (Download) 2018-06-26377.7 KB
Section 07: Data Communiqué #2 (Download) 2018-07-03286.68 KB
Section 07: Data Communiqué #3 (Download) 2018-07-30312.98 KB