FOR EARLY TERMINATION ONLY: Complete the Study Termination CRF and complete permission to contact or [site specific log]. As indicated per protocol, arrange future contact for follow-up on ongoing AEs. Perform QC1 review while participant is still present, review the following for completion and clear documentation: Visit checklist, Pelvic Exam Checklist, and Follow-Up Visit CRFs Behavioral Assessments Summary/CASI Tracking CRFs for Exit CASI, and IDI, if applicable. LDMS Specimen Tracking Sheet and Timed Cervical/Specimen Storage CRFs for consistency between forms. AE and Concomitant Medications CRFs to ensure all conditions, medications, AEs are captured consistently and updated. Chart notes Schedule the Final Contact visit between 24-72 hours after the PUEV visit, using the participant’s Visit Calendar Tool. Provide any other study informational materials, site contact information, and instructions to contact the site for additional information and/or counseling if needed before the next visit: [add site-specific list if desired]. male condoms Provide Reimbursement
FOR EARLY TERMINATION ONLY: Complete the Study Termination CRF and complete permission to contact or [site specific log]. As indicated per protocol, arrange future contact for follow-up on ongoing AEs. Perform QC1 review while participant is still present, review the following for completion and clear documentation: Visit checklist, Pelvic Exam Checklist, and Follow-Up Visit CRFs Behavioral Assessments Summary/CASI Tracking CRFs for Exit CASI, and IDI, if applicable. LDMS Specimen Tracking Sheet and Timed Cervical/Specimen Storage CRFs for consistency between forms. AE and Concomitant Medications CRFs to ensure all conditions, medications, AEs are captured consistently and updated. Chart notes Schedule the Final Contact visit between 24-72 hours after the PUEV visit, using the participant’s Visit Calendar Tool. Provide any other study informational materials, site contact information, and instructions to contact the site for additional information and/or counseling if needed before the next visit: [add site-specific list if desired]. male condoms Provide Reimbursement