Accreditation and Assessment
- Related Items Stored in Other Folders
- Accreditation Organizations
- Impact of Laboratory Accreditation on Patient Care and the Health System
- Acc00-13
- PBMC Laboratory Readiness Guide and Resources
- Audit Reference - Weblink on HANC for PBMC Laboratory Readiness Guide Acc00-15
- Requirements for Laboratories Performing Testing for DAIDS-Supported and/or Sponsored Clinical Trials
- Weblink to DAIDS requirements for Clinical Trails. Acc00-17
- Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trails Requirements for U.S. Laboratories
- Weblink to DAIDS requirements for Clinical Trails- Acc00-18
- Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials Requirements for Non-U.S Laboratories
- Weblink to DAIDS requirements for Clinical Trails - Non U.S. Lab - Acc00-19
- DCLOT Algorithm for Determining Level of Validation Required for Endpoints Assays
- Weblink to DAIDS requirements for Clinical Trails Add III - Acc0020
- Code of Federal Regulations for Good Laboratory Practice for Non-Clinical Studies
- 21 CFR Part 58 Acc00-ND
- Code of Federal Regulations for Clinical Laboratories
- Weblink to federal regulations for clinical laboratories 42 CFR Part 493
- SIVCO Inspection Management Software
- Software to manage internal audit and accreditation inspection requirements Acc00-ND
- GLI Quality Tool for Laboratory Accreditation
- Audit Reference - Organization and Personnel - Website with step-by-step instruction on getting accreditation for your TB laboratory - Acc-ND
- 501(k) Premarket Notification on FDA
- website to FDA 510(k) search
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General Lab Audit Checklist_15Aug21
- Checklist for general lab
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PBMC Lab Audit Checkist_15Aug21
- Checklist for PBMC lab
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Central Lab Audit Checklist_15Aug21
- Checklist for Central Lab
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DAIDS Audit Preparation Guideline.doc
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TB Lab Audit Shell_15Aug21
- Checklist for TB lab
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Specimen Repository Audit Checklist_15Aug21
- Checklist for Repository lab
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Lab Self Inspection Worksheet - Microbiology
- SMILE created Worksheet for self inspection of microbiology laboratory.
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Study Plan Used for a Specific Laboratory Endpoint Assay Example
- Audit Reference - Introduction - An example of a Study Plan for Laboratory Endpoint Assay
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