HELPFUL DOWNLOADS

Below are several useful documents for Quality Assurance and Data Management professionals. All documents are in Adobe Acrobat (PDF) format and contain interactive tables of contents with hyperlinks to individual sections. Check back often for additional downloads.

SCIENTIFIC and MEDICAL CONVENTIONS
(for auditing, writing, data management, and biostatistics)

Clinical Pathology Tests

Names, Acronyms, Units, and Conversion Factors

Download this document (130 KB PDF Document)

FDA and CVM REGULATIONS/GUIDELINES

FDA Part 11 - Electronic Records

21 CFR Part 11 Electronic Records: Electronic Signatures; Final Rule

Source: 21 CFR part 11 (April 1, 2003) and 62 Fed. Reg. 13430-13461 (March 20, 1997)

Download this document (610 KB PDF Document)

FDA GLPs

21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

Download this document (573 KB PDF Document)

This document is also available in hardcopy booklet form.

EPA GLPs

40 CFR Part 160 - Federal Insecticide, Fungicide and Rodenticide Act (FIFRA): Good Laboratory Practice Standards

40 CFR Part 792 - Toxic Substances Control Act (TSCA): Good Laboratory Practice Standards

Download this document (2.1 MB PDF Document)

This document is also available in hardcopy booklet form.

Comparison of FDA and EPA GLPs

Comparison of 21 CFR Part 58, 40 CFR Part 160, and 40 CFR Part 792

Download this document (249 KB PDF Document)

FDA Veterinary Drug Regulations

21 CFR Part 511 - New Animal Drugs for Investigational Use and

21 CFR Part 514 - New Animal Drug Applications

Download this document (765 KB PDF Document)

CVM Guidelines and Guidance Documents

No. 85 (VICH GL9) - Good Clinical Practice

Download this document (267 KB PDF Document)

This documentis also available in hardcopy booklet form.

BSI PRESENTATIONS

Compliance Coordination: Contract Quality Assurance for GLP Test Sites

Presented by Barbara B. Randolph, Sherry Puterbaugh Fowler, and Jason R. Plaxco at the 32nd Society of Quality Assurance Annual Meeting – April 3-8, 2016, Dallas, TX

Download this document (148 KB PDF Document – Full poster)

Recent Veterinary GCP and University GLP Regulatory Inspectional Experiences: A Comparison of Perceptions from Site Qualification to Site Inspection

Presented by Jason R. Plaxco at the 30th Society of Quality Assurance Annual Meeting – April 6-11, 2014, Las Vegas, NV

Download this document (120 KB PDF Document – Full presentation)

Recent Observations on Performing GLP QAU functions at Non-GLP Facilities

Presented by Jason R. Plaxco at the 29th Society of Quality Assurance Annual Meeting – April 28 – May 3, 2013, Indianapolis, IN

Download this document (109 KB PDF Document – Full presentation)

Clinical Laboratory Inspections: Know What to Look For

Presented by Barbara Randolph at the 27th Society of Quality Assurance Annual Meeting - March 27-April 1, 2011, San Antonio, TX

Download this document (28 KB PDF Document - Full panel presentation)

Checklists and Templates: Facility Audit Help or Hindrance

Presented by Barbara Randolph, Melissa Hughes, and Jason Plaxco at the 26th Society of Quality Assurance Annual Meeting - April 25-30, 2010, Cincinnati, OH

Download this document (60 KB PDF Document - Full poster)

Quality Assurance in Multi-Site Studies

Presented by Patrick Carver, Barbara Randolph, Melissa Hughes, and Jason Plaxco at the 25th Society of Quality Assurance Annual Meeting - April 19-24, 2009, San Diego, CA

Download this document (116 KB PDF Document - Full poster)

Departmentalization Coordination: A Team Approach

Presented by Barbara Randolph, Patrick Carver and Melissa Hughes at the 24th Society of Quality Assurance Annual Meeting - April 20-25, 2008, Memphis, TN

Download this document (91 KB PDF Document - Full poster)

Download this document (31 KB PDF Document - Text only)

Computer Based Tools for the Quality Assurance Auditor

Presented by Richard Vanderpool and Barbara Randolph at the 22nd Society of Quality Assurance Annual Meeting - April 23-27, 2006, Pheonix, AZ

Download this document (250 KB PDF Document)

Polynomial Regression templates and supporting documentation

Presented by Richard Vanderpool at the 1st Global QA Conference and 21st Society of Quality Assurance Annual Meeting - February 20-24, 2005, Orlando, FL

    (69 KB Microsoft Excel Document)

    (173 KB PDF Document)

    (37 KB PDF Document)

    (38 KB PDF Document)

The Lexicon - One CRO’s Experience Using Medical Dictionaries in Clinical Trial Data Management

Presented by C. Michael Bailey at the Drug InformationAssociation's 18th AnnualClinical Data Management Conference and Exposition - March 30-April 2, 2004, Philadelphia, PA

Download this document (60 KB PDF Document)

Clinical Data Management Personnel: The Evolution of Roles and Skills in a Small CRO

Presented by C. Michael Bailey at the Drug InformationAssociation's 19th AnnualClinical Data Management Conference and Exposition - March 21-24, 2004, Philadelphia, PA

Download this document (980 KB PDF Document)

Financial Issues Related to Outsourcing:

Session Chairman Donald L. Crone at the Drug InformationAssociation's 40th Annual Meeting and Exposition - June 13-17, 2004, Washington, DC

Download this document (225 KB PDF Document)

Evolving Roles and Skills in Clinical Data Management: Where Did We Come From and Where Are We Going?

Session Chairman C. Michael Bailey at the Drug InformationAssociation's 40th Annual Meeting and Exposition - June 13-17, 2004, Washington, DC

Download this document (687 KB PDF Document)

Case Report Form Design Issues

Presented by Phyllis Rathman at the Society of Clinical Research Associates 13th Annual Converence - September 23-26, 2004, Montreal, QC, Canada

Download this document (594 KB PDF Document)