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Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials Requirements for Non-U.S Laboratories
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Weblink to DAIDS requirements for Clinical Trails - Non U.S. Lab - Acc00-19
Located in
Resources
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Accreditation and Assessment
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DCLOT Algorithm for Determining Level of Validation Required for Endpoints Assays
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Weblink to DAIDS requirements for Clinical Trails Add III - Acc0020
Located in
Resources
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Accreditation and Assessment
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GCLP Related Documents
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The following SMILE resources are examples to support DAIDS GCLP Guidelines. These examples should be customized based on the laboratory’s protocol requirements and practices
Located in
Resources
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pSMILE User Guide
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Located in
Resources
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SMILE Resources
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Mycobacteriology (TB) Source Book
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Located in
Resources
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…
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Section Specific Information
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Microbiology
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Laboratory Instruction for Web-Based Investigation Report - PowerPoint
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Audit Reference - EQA A PowerPoint to explain the Web-Based IR laboratory instructions
Located in
Resources
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…
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EQA
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EQA Investigation Form
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Laboratory Instruction for Web-Based Investigation Report
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Audit Reference - Word document with instructions for the Laboratory for the Web-Based IR
Located in
Resources
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…
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EQA
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EQA Investigation Form
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Network Instruction for Web-Based Investigation Report
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Audit Reference - EQA - Word Document for Network instructions on the Web Based IR
Located in
Resources
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…
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EQA
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EQA Investigation Form
