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Forms (All applications are found under the Methods Submission tab)

1. Application Instructions

2. Performance Tested Methods Program Policies & Procedures
    1. Appendix 1 Fee Schedule
    2. Appendix 2 Consulting Application
    3. Appendix 3 Consulting Agreement
    4. Appendix 4 Consulting Waiver
    5. Appendix 5 PTM Review Form
    6. Appendix 6 Review Agreement
    7. Appendix 7 Check List
    8. Appendix 8 General Criteria for Independent Laboratories
    9. Appendix 9 Lab Contract
    10. Appendix 11 Method Validation Study Report Format Example
    11. Appendix 12 Package Insert Requirements
    12. Appendix 13 PTM Certificate
    13. Appendix 14 License Agreement
    14. Appendix 15 Annual Review Form
    15. Appendix 16 Reinstatement Review Form
    16. Appendix 17 Method Modification Application
    17. Appendix 18 Definitions & Modification Guideline
    18. Appendix 19 PTM Review & Recognized Application
    19. Flowchart 1 
    20. Flowchart 2 
    21. Flowchart 3 PTM Application Review 
    22. Flowchart 4 Independent Testing Site Procedures 
    23. Flowchart 5 Validation Study Report Review 
    24. Post Certification Process 
    25. Re-Certification of Lapsed PTM Assay
    26. Appendix A Certificate Mark License Agreement Distributors
3. Consulting Package:
    1. Application
    2. Agreement
    3. Waiver
    4. Fee Schedule
    5. Appendix 23: Research Institute Program Flowcharts
4. Contributing Member Application

5. PTM Review Application Package:
    1. Application [including Harmonizations]
    2. Agreement
    3. Check List
    4. Fee Schedule
    5. General Criteria for Independent Laboratory
    6. Method Validation Study Report Example
    7. Package Insert Requirements
    8. Certificate Example
    9. Certification Mark License Agreement
    10. Appendix A Certificate Mark License Agreement Distributors
6. Appendix 11: Method Validation Study Report Format Example

7. Annual PTM Review Application Package:
    1. Appendix 15: Annual PTM Renewal Application
    2. Renewal Modification Guidelines
8. Appendix 16: Re-Instatement Application Form

9. Modification/Extension Application Package: 
    1. Appendix 17: PTM Modification Application
    2. Appendix 18: Test Method Definitions & Modification Guidelines
10. Appendix 19: PTM Reviewed & Recognized Application

11. Appendix 21: Policy on Volunteer Conflict of Interest

12. Appendix 23: Research Institute Program Flowcharts 
    1. Form 1: Program Overview
    2. Form 2: Consulting Procedures
    3. Form 3: PTM Application Review
    4. Form 4: Independent Test Site Procedures
    5. Form 5: Validation Study Report Review
    6. Form 6: Post Certification Process
13. Re-Certification of Lapsed PTM
    1. Instructions for Re-Certification of Lapsed PTM
14. RI By-Laws

Policies and Procedures


RI Policies and Procedures

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