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.
Some of these documents in addition to others are available in hardcopy booklet form
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 - Requires Adobe Acrobat Reader)
Tables 3 & 4 from 2003 SQA poster titled "21 CFR Part 11 through FDA Warning Letters"
by Richard Vanderpool and Kay Shuttleworth
Download this document (72 KB PDF Document - Requires Adobe Acrobat Reader)
FDA GLPs
21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
Download this document (573 KB PDF Document - Requires Adobe Acrobat Reader)
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 and
40 CFR Part 792 - Toxic Substances Control Act (TSCA): Good Laboratory Practice Standards
Download this document (2.1 MB PDF Document - Requires Adobe Acrobat Reader)
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 - Requires Adobe Acrobat Reader)
FDA GCPs
Side-by-Side comparison of FDA's Guidance for Industry documents:
Computerized Systems Used in Clinical Trials - April 1999 versus September
2004 Revision 1 Draft
Download this document (266 KB PDF Document - Requires Adobe Acrobat Reader)
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 - Requires Adobe Acrobat Reader)
CVM Guidelines and Guidance Documents
No. 85 (VICH GL9) - Good Clinical Practice
Download this document (267 KB PDF Document - Requires Adobe Acrobat Reader)
This document is also available in hardcopy booklet form.
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 - Requires Adobe Acrobat Reader)
PRESENTATIONS
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 - Requires Adobe Acrobat Reader)
Initiation of Contract Analytical and Bioanalytical Laboratory Analysis Projects:
Quality Beginnings Facilitate Quality Outcomes
Presented by Patrick H. Carver at the 1st Global QA Conference and
21st Society of Quality Assurance Annual Meeting - February 20-24, 2005, Orlando FL
Download this document (569 KB PDF Document - Requires Adobe Acrobat Reader)
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
Excel Solver Templates (69 KB Microsoft Excel Document)
QA 2005 Expanded Poster (173 KB PDF Document - Requires Adobe Acrobat Reader)
SAS 1st Order Output (37 KB PDF Document - Requires Adobe Acrobat Reader)
SAS 2nd Order Output (38 KB PDF Document - Requires Adobe Acrobat Reader)
The Lexicon - One CRO’s Experience Using Medical Dictionaries
in Clinical Trial Data Management
Presented by C. Michael Bailey at the Drug Information Association's 18th Annual Clinical Data Management Conference and Exposition - March 30-April 2, 2004, Philadelphia PA
Download this document (60 KB PDF Document - Requires Adobe Acrobat Reader
Clinical Data Management Personnel:
The Evolution of Roles and Skills in a Small CRO
Presented by C. Michael Bailey at the Drug Information Association's 19th Annual Clinical Data Management Conference and Exposition - March 21-24, 2004, Philadelphia PA
Download this document (980 KB PDF Document - Requires Adobe Acrobat Reader)
Financial Issues Related to Outsourcing:
Session Chairman Donald L. Crone at the Drug Information Association's 40th Annual
Meeting and Exposition - June 13-17, 2004, Washington DC
Download this document (225 KB PDF Document - Requires Adobe Acrobat Reader)
Evolving Rolls and Skills in Clinical Data Management:
Where Did We Come From and Where Are We Going?
Session Chairman C. Michael Bailey at the Drug Information Association's 40th Annual
Meeting and Exposition - June 13-17, 2004, Washington DC
Download this document (687 KB PDF Document - Requires Adobe Acrobat Reader)
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 - Requires Adobe Acrobat Reader)
