Back to top
DescriptionDateSize
Individual Sections
Overview and Control Document – Version History and Notice of Changes (Download) 2020-08-17704 KB
Table of Contents (Download) 2020-08-17211.41 KB
Section 01: Introduction (Download) 2020-08-17252.43 KB
Section 02: Documentation Requirements (Download) 2019-11-15211.7 KB
Section 03: Accrual and Retention (Download) 2020-08-17219.4 KB
Section 04: Informed Consent (Download) 2019-11-15167.24 KB
Section 05: Study Procedures (Download) 2020-08-17369.21 KB
Section 06: Counseling Considerations (Download) 2020-04-22210.82 KB
Section 07: Behavioral Measures (Download) 2019-11-15257.99 KB
Section 08: Study Product Considerations for Non-Pharmacy Staff (Download) 2019-11-15392.59 KB
Section 09: Clinical Considerations (Download) 2020-04-22289.43 KB
Section 10: Adverse Event Reporting and Safety Monitoring (Download) 2020-04-22348.16 KB
Section 11: Laboratory Considerations (Download) 2020-08-17715.83 KB
Section 12: Data Collection (Download) 2020-08-17649.74 KB
Section 13: Data Communiqués (Download) 2019-11-1579.83 KB
Section 13: Data Communiqué #1 (Download) 2020-04-16196.45 KB
Section 13: Data Communiqué #2 (Download) 2020-05-19173.07 KB
Section 14: Study Reporting Plan (Download) 2019-11-15166.41 KB