PD log CRF MTN-025 Study Specific Training Phase 2 Follow-Up – Day 3 Time Presentation Presenter References/Materials* 10-10:45am 1. FHI 360 SSP Section 6 (Follow-up Procedures) 4-4:45am EST Follow-up Visit Types & Procedures Protocol Section 7.4 and Appendix I M1&2 Follow-up Checklist (Month 1 & Quarterly 2/Quarterly) PUEV/Term SSP Section 12 (Counseling) Follow-up HIV Prevention Options Counseling Minimum procedures required to dispense rings during f/u Fast-tracking’ ring supply visits 3 Considerations (transition to quarterly visits) 10:45-11:45am 2. Safety SSP Section 10 (Clinical Considerations) 4:45-5:45am EST Follow-up Medical/Menstrual History MDs SSP Section 11 (AE Reporting and AE/SAE/EAEs Definitions Safety Monitoring) AE Reporting and 3. Safety SSP Section 10 (Clinical Considerations) MDs Protocol Requirements for Product Protocol Section 9 Holds/Discontinuations 5:45-6:15am EST Product Use Management Flow Sheets 12:15-1:00pm Lunch Break 6:15-7am EST 1-1:20pm FHI 360 4. SSP Section 2 (Decliners) SSP Section 6 (Follow-up 7-7:20am EST Off Site Visit Procedures and Procedures) Documentation Considerations SSP Section 8 (Participant Retention) SSP Section 9 (Study Product Considerations) SSP Section 10 (Product Hold/Discontinuation) SSP Section 12 (Counseling) 1:20-1:40pm FHI 360 SSP Section 5 (Informed Consent) SSP Section 6 (Follow-up 7:20-7:40am EST 5. Procedures) Retention Definitions/Strategies SSP Section 8 (Participant Participant Transfers Retention) Termination/Withdrawals Protocol Section 9 (Termination & Early Withdrawal) 1:40-1:55 pm 6. SCHARP SSP Section 8 (Retention) Participant Tracking Database User 7:40-7:55am EST Overview of participant tracking Manual database
PD log CRF MTN-025 Study Specific Training Phase 2 – Follow-Up Day 3 Time Presentation Presenter References/Materials* 10-10:45am 4-4:45am EST 1. Follow-up Visit Types & Procedures M1&2 Quarterly PUEV/Term Follow-up HIV Prevention Options Counseling Minimum procedures required to dispense rings during f/u Fast-tracking’ ring supply visits 3 Considerations (transition to quarterly visits) FHI 360 SSP Section 6 (Follow-up Procedures) Protocol Section 7.4 and Appendix I Follow-up Checklist (Month 1 & 2/Quarterly) SSP Section 12 (Counseling) 10:45-11:45am 4:45-5:45am EST 2. Follow-up Medical/Menstrual History AE/SAE/EAEs Definitions AE Reporting and Safety MDs SSP Section 10 (Clinical Considerations) SSP Section 11 (AE Reporting and Safety Monitoring) 5:45-6:15am EST 3. Protocol Requirements for Product Holds/Discontinuations Safety MDs SSP Section 10 (Clinical Considerations) Protocol Section 9 Product Use Management Flow Sheets 12:15-1:00pm 6:15-7am EST Lunch Break 1-1:20pm 7-7:20am EST 4. Off Site Visit Procedures and Documentation Considerations FHI 360 SSP Section 2 (Decliners) SSP Section 6 (Follow-up Procedures) SSP Section 8 (Participant Retention) SSP Section 9 (Study Product Considerations) SSP Section 10 (Product Hold/Discontinuation) SSP Section 12 (Counseling) 1:20-1:40pm 7:20-7:40am EST 5. Retention Definitions/Strategies Participant Transfers Termination/Withdrawals FHI 360 SSP Section 5 (Informed Consent) SSP Section 6 (Follow-up Procedures) SSP Section 8 (Participant Retention) Protocol Section 9 (Termination & Early Withdrawal) 1:40-1:55 pm 7:40-7:55am EST 6. Overview of participant tracking database SCHARP SSP Section 8 (Retention) Participant Tracking Database User Manual
MTN-025%20HOPE%20Study%20Specific%20Training%20Full%20Agenda.docx