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DescriptionDateSize
Individual Sections
Overview of Section Contents and Identification of Current Section Versions (Download) 2018-04-06194.5 KB
Section 01: Introduction (Download) 2018-03-06304.61 KB
Section 02: Documentation Requirements (Download) 2018-04-06606.82 KB
Section 03: Accrual, Eligibility Determination, & Study Procedures (Download) 2018-04-06321.89 KB
Section 04: Informed Consent (Download) 2018-03-06457.18 KB
Section 05: Safety and Counseling Considerations (Download) 2018-03-06328.63 KB
Section 06: Data Management (Download) 2018-03-30574.6 KB
Section 07: Data Communiques (Download) 2018-03-06268.04 KB