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The quest for knowledge never ends. Here's what we've found to be useful.
Let us know other resources to include and why they are significant.
One of our principals, Sanjaya Joshi, has published papers
on LECIS and the biopharma community in Seattle. General resources
that are always usefule include dictionaries, thesauruses and encyclopedias.
Standards for life sciences and engineering cover a broad spectrum.
A critical knowledge area is federal regulations governing how companies
interact with individuals and patients; two examples are PDMA and HIPAA.
Government agencies include federal agencies concerning health
and welfare of the people, while organizations listed are non-profits and
other independent bodies.
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Published Papers |
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General Resources |
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Standards |
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Laboratory |
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- LECIS -- Laboratory Equipment Control Interface Standard
- LECIS summary
- AUTO3-A -- Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
- AUTO5-A -- Laboratory Automation: Electromechanical Interfaces; Approved Standard
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Health and Medicine |
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- DICOM -- Digital Imaging and Communications in Medicine
- HL7 -- Health Level 7
- HRQL -- Health-related quality of life methods
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Clinical Trials |
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- CDISC standards -- Clinical Data Interchange Standards Consortium -- SDTM (submissions), ODM (operational), ADaM (analysis), LAB (laboratory), PRG (protocol), SEND (non-clinical), CRT-DDS (case report tabulation)
- AnIML -- Analytical Information Markup Language
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Flow Cytometry |
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Mass Spectometry |
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Federal Regulations |
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CFR |
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Code of Federal Regulations
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21 CFR Part 11 |
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Electronic Records; Electronic Signatures
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21 CFR Part 58 |
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Good Laboratory Practice for Nonclinical Laboratory Studies
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PDMA |
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21 CFR Part 203 -- Prescription Drug Marketing (PDMA)
- FDA Center for Devices and Radiological Health on PDMA
- Search for 21CFR203 on NARA CFR
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GMP-- QS |
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21 CFR Part 820 (Quality System Regulation)
Good Manufacturing Practices (GMP) Quality System (QS)
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HIPAA |
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Health Insurance Portability and Accountability Act
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Government Agencies |
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CDC |
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Centers for Disease Control and Prevention
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DHHS |
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U.S. Department of Health and Human Services
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EPA |
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U.S. Environmental Protection Agency
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FDA |
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U.S. Food and Drug Administration
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NIST |
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National Institute of Standards and Technology
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OSHA |
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U.S. Department of Labor, Occupational Safety and Health Administration
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Organizations |
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