MATRIX-001 Study Documents
| Description | Date | Size |
|---|
| Clinical Supplies Accountability Log (Download) | 2023-10-01 | 238.6 KB |
| Emergency Contact List (Download) | 2023-10-26 | 142.28 KB |
| Informed Consent Coversheet (Download) | 2023-10-01 | 32.94 KB |
| Participant Contact Log (Download) | 2023-10-01 | 242.13 KB |
| Protocol Counseling Guide and Worksheet (Download) | 2023-10-01 | 46.1 KB |
| Protocol Deviation Log (Download) | 2023-10-01 | 346.73 KB |
| PTID Name Linkage Log (Download) | 2023-10-01 | 239.75 KB |
| Screening and Enrollment Log (Download) | 2023-10-01 | 244.14 KB |
| Study Product Record of Receipt/Return Log (Download) | 2023-10-01 | 239.82 KB |
| Study Product Destruction Log (Download) | 2023-10-01 | 239.74 KB |
| Eligibility Checklist (Download) | 2023-10-01 | 50.62 KB |
| Serious Adverse Event Form (SAE) (Download) | 2023-10-25 | 42.86 KB |
| Vaginal Insert Guide (Download) | 2023-11-07 | 1.68 MB |
| Vaginal Insert Use and Adherence Tool (Download) | 2023-08-03 | 163.57 KB |
| Prescription (Download) | 2023-10-01 | 27.06 KB |
| Sample Informed Consent Comprehension Assessment (Download) | 2023-03-28 | 132.62 KB |
| Protocol Safety Review Team Query Form (Download) | 2023-05-25 | 27.61 KB |
| Participant Visit Calendar Tool (Download) | 2023-11-07 | 97.08 KB |
| Clarification Memo #01 to MATRIX-001 (Download) | 2023-08-22 | 178.66 KB |
| Clarification Memo #02 to MATRIX-001 (Download) | 2023-09-27 | 170.56 KB |
| Clarification Memo #03 to MATRIX-001 (Download) | 2023-10-27 | 170.62 KB |
| MATRIX-001 CRF Binder v2.0 (Download) | 2023-10-25 | 1.11 MB |
| Question by Question (QxQ) Guide (Download) | 2023-10-24 | 206.63 KB |
| Response Cards (Download) | 2023-11-17 | 167.32 KB |
| MATRIX-001 Protocol Version 1.0, dated May 4, 2023 (Download) | 2023-05-04 | 1.58 MB |
| Table of Contents (Download) | 2023-10-18 | 169.91 KB |
| Section 01 – Introduction (Download) | 2023-10-18 | 208.02 KB |
| Section 02 – Documentation Requirements (Download) | 2023-10-18 | 326.2 KB |
| Section 03 – Accrual and Retention (Download) | 2023-10-18 | 251.22 KB |
| Section 04 – Informed Consent (Download) | 2023-10-18 | 260.87 KB |
| Section 05 – Study Procedures (Download) | 2023-10-18 | 265.32 KB |
| Section 06 – Study Product Considerations for Non-Pharmacy Staff (Download) | 2023-10-18 | 265.77 KB |
| Section 07 – Clinical Considerations (Download) | 2023-10-18 | 364.99 KB |
| Section 08 – Adverse Event Reporting and Safety Monitoring (Download) | 2023-10-18 | 348.14 KB |
| Section 09 – Laboratory Considerations (Download) | 2023-10-18 | 832.63 KB |
| Section 10 – Counseling Considerations (Download) | 2023-10-18 | 229.02 KB |
| Section 11 – Behavioral Measures (Download) | 2023-10-18 | 899.08 KB |
| Section 12 – Data Collection (Download) | 2023-10-18 | 351.96 KB |
| Section 13 – Data Communiqués and Operational Guidance (Download) | 2023-10-18 | 171.14 KB |
| Section 14 – Study Reporting Plan for Clinical Data (Download) | 2023-10-18 | 275.52 KB |
| Screening Visit Checklist (Download) | 2023-10-01 | 30.52 KB |
| Enrollment Visit Checklist (Download) | 2023-10-01 | 27.27 KB |
| Randomization Visit Checklist (Download) | 2023-10-01 | 24.24 KB |
| 24 Hours Post 3rd Dose Visit Checklist (Download) | 2023-10-01 | 26.25 KB |
| 10-14 days post V4 and 2 days post V5 (Download) | 2023-10-01 | 27.1 KB |
| Post Last Dose Visit Checklist (Download) | 2023-10-01 | 26.63 KB |
| Study Exit Visit and Early Termination Visit (Download) | 2023-10-01 | 22.93 KB |