MATRIX-001 Study Documents

DescriptionDateSize
Ancillary Documents
Clinical Supplies Accountability Log (Download) 2023-10-01238.6 KB
Eligibility Checklist (Download) 2023-10-0150.62 KB
Emergency Contact List (Download) 2023-10-26142.28 KB
Informed Consent Coversheet (Download) 2023-10-0132.94 KB
Participant Contact Log (Download) 2023-10-01242.13 KB
Participant Visit Calendar Tool (Download) 2023-11-0797.08 KB
Prescription (Download) 2024-02-1227.22 KB
Protocol Counseling Guide and Worksheet (Download) 2023-10-0146.1 KB
Protocol Deviation Log (Download) 2023-10-01346.73 KB
Protocol Safety Review Team Query Form (Download) 2024-07-1127.54 KB
PTID Name Linkage Log (Download) 2024-02-07237.83 KB
Sample Informed Consent Comprehension Assessment (Download) 2023-03-28132.62 KB
Screening and Enrollment Log (Download) 2023-10-01244.14 KB
Serious Adverse Event Form (SAE) (Download) 2023-10-2542.86 KB
Study Product Destruction Log (Download) 2023-10-01239.74 KB
Study Product Record of Receipt/Return Log (Download) 2023-10-01239.82 KB
Vaginal Insert Guide (Download) 2023-11-071.68 MB
Vaginal Insert Use and Adherence Tool (Download) 2023-08-03163.57 KB
Clarification Memos
Clarification Memo #01 to MATRIX-001 (Download) 2023-08-22178.66 KB
Clarification Memo #02 to MATRIX-001 (Download) 2023-09-27170.56 KB
Clarification Memo #03 to MATRIX-001 (Download) 2023-10-27170.62 KB
Clinical Research Forms and In-Depth Interview Materials
MATRIX-001 CRF Binder v2.0 (Download) 2023-10-251.13 MB
Question by Question (QxQ) Guide (Download) 2024-03-05230.58 KB
Response Cards (Download) 2023-11-17167.32 KB
Protocols
MATRIX-001 Protocol Version 1.0, dated May 4, 2023 (Download) 2023-05-041.58 MB
Study Specific Procedures Manual - Individual Sections
Overview and Control Document-Version History and Notice of Changes (Download) 2024-05-28434.91 KB
Table of Contents (Download) 2024-05-28170.01 KB
Section 01 – Introduction (Download) 2023-10-18208.02 KB
Section 02 – Documentation Requirements (Download) 2023-10-18326.2 KB
Section 03 – Accrual and Retention (Download) 2023-10-18251.22 KB
Section 04 – Informed Consent (Download) 2023-10-18260.87 KB
Section 05 – Study Procedures (Download) 2023-10-18265.32 KB
Section 06 – Study Product Considerations for Non-Pharmacy Staff (Download) 2023-10-18265.77 KB
Section 07 – Clinical Considerations (Download) 2024-05-28468.11 KB
Section 08 – Adverse Event Reporting and Safety Monitoring (Download) 2023-10-18348.14 KB
Section 09 – Laboratory Considerations (Download) 2024-03-19936.19 KB
Section 10 – Counseling Considerations (Download) 2023-10-18229.02 KB
Section 11 – Behavioral Measures (Download) 2023-10-18899.08 KB
Section 12 – Data Collection (Download) 2023-10-18351.96 KB
Section 13 – Data Communiqués and Operational Guidance (Download) 2023-10-18171.14 KB
Section 13 – Data Communique #1 (Download) 2024-03-13297.88 KB
Section 14 – Study Reporting Plan for Clinical Data (Download) 2023-10-18275.52 KB
Study Specific Procedures Manual-Operational Guidance
Operational Guidance #1 (Download) 2024-01-19394.5 KB
Operational Guidance #2 (Download) 2024-01-19375.61 KB
SBR Operational Guidance #01 (Download) 2024-03-05513.4 KB
SBR Operational Guidance #02 (Download) 2024-05-22866.58 KB
Visit Checklists
10-14 days post V4 and 2 days post V5 (Download) 2023-10-0127.1 KB
24 Hours Post 3rd Dose Visit Checklist (Download) 2023-10-0126.25 KB
Enrollment Visit Checklist (Download) 2023-10-0127.27 KB
Post Last Dose Visit Checklist (Download) 2023-10-0126.63 KB
Randomization Visit Checklist (Download) 2023-10-0124.24 KB
Screening Visit Checklist (Download) 2023-10-0130.52 KB
Study Exit Visit and Early Termination Visit (Download) 2023-10-0122.93 KB