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Appendix IV: Sample Informed Consent Forms (Download) 2006-03-13159.82 KB
Manual
Overview and Version Control (Download) 2006-10-118.08 KB
Section 01: Introduction (Download) 2006-06-01114.36 KB
Section 02: Protocol (Download) 2006-06-0152.62 KB
Section 03: Documentation Requirements (Download) 2006-06-01217.08 KB
Section 04: Participant Accrual (Download) 2006-06-01729.13 KB
Section 05: Informed Consent (Download) 2006-06-01162.57 KB
Section 06: Participant Follow-up (Download) 2006-06-01458.63 KB
Section 07: Visit Checklists (Download) 2006-06-0164.65 KB
Section 08: Participant Retention (Download) 2006-06-01104.39 KB
Section 09: Study Gel Considerations for Non-Pharmacy Staff (Download) 2006-06-01220.74 KB
Section 10: Clinical Considerations (Download) 2006-08-30240.3 KB
Section 11: Adverse Event Reporting and Safety Monitoring (Download) 2006-06-22177.28 KB
Section 12: Laboratory Considerations (Download) 2006-10-09481.3 KB
Section 13: Data Collection (Download) 2006-06-271.35 MB
Section 14: Data Communiques (Download) 2006-06-2810.01 KB
Section 15: Study Reporting Plan (Download) 2006-06-2833.11 KB