Clinical Trials and Training from Clinical Device Group Inc; Nancy J Stark

CDG Publications on Medical Device Clinical Research & Biocompatibility

These tabs list all of the writings of Dr. Nancy J Stark. Some are email broadcasts that were later added to CDG's Whitepapers Blog, some are reviewed articles in industry publications, some are books and tools published by CDG Inc, others were invited presentations or web presentions produced by CDG Inc. Finally, some are academic articles by Dr. Stark from her graduate and post-graduate career. All of the publications are available, some for free and some for sale. Check the tab to see how to obtain a copy. You can download Dr. Stark's CV here.

Whitepapers
Articles
Books & Tools
Invited Presentations
Web Presentations
Academic Research

1-Whitepapers

Our Whitepapers Blog helps you keep in touch with basic, advanced, and timely topics in clinical research, biocompatibility, regulatory, reimbursement, and other medical device pre-approval issues. Visit the blog to obtain a full-text copy of the whitepaper.

  "Quality Systems for Clinical Research-YES", Nancy J Stark, 09 December 2015.
  "Formatting Clinical Evaluation Reports", Charles Hurwitz and Nancy J Stark, 06 November 2015.
  "Medical Devices in the Home—FDA's Home Use Device Initiative", Nancy J Stark, 23 September 2013.
  "Registry Studies: Just like Clinical Trials", Nancy J Stark, 22 October 2012.
  "Relationship Building in Clinical Trials", Nancy J Stark, 22 January 2012.
  "Risk-Based Monitoring−The New FDA Guidance", Nancy J Stark, 13 November 2011.
  "Literature Evaluations for Biological Safety", Nancy J Stark, 27 September 2011.
  "Clinical Trial Agreements", Nancy J Stark, 2 September 2011.
  "Registry Studies: Why and How", Nancy J Stark, 20 July 2011.
  "Medical Device Biocompatibility", Nancy J Stark and Dan E McLain, 1 June 2011.
  "Reimbursement Strategies for New Technologies", Nancy J Stark and Vincent Jaeger, 8 May 2011.
  "Getting to First-in-Man Studies", Nancy J Stark and Dan E McLain, 7 April 2011.
  "ISO 14155 (2011) Good Clinical Practice for Medical Devices Is Here−It's Time to Update Your Procedures!", Nancy J Stark, 27 January 2011.
  "CDRH's 510(k) Working Group Preliminary Report−Findings 6 & 7", Nancy J Stark and Kathleen Johnson, 25 January 2011.
  "European Medical Device Update", Nancy J Stark, 29 December 2010.
  "CDRH's 510(k) Working Group Preliminary Report−Finding 5", Nancy J Stark and Kathleen Johnson, 16 December 2010.
  "CDRH's 510(k) Working Group−Findings 4(b)", Nancy J Stark and Kathleen Johnson, 30 November 2010.
  "CDRH's 510(k) Working Group−Findings 3 & 4(a)", Nancy J Stark and Kathleen Johnson, 22 November 2010.
  "CDRH's 510(k) Working Group−Findings 1 & 2", Nancy J Stark, Kathleen Johnson, and Gail Radcliffe, 9 November 2010.
  "CDRH's 510(k) Working Group Preliminary Report", Nancy J Stark and Kathleen Johnson, 29 October 2010.
  "Statistics for Clinical Trials", Nancy J Stark, 29 October 2010.
  "Good Monitoring Practices: US and ISO Comparison", Nancy J Stark, 18 October 2010.
  "Good Monitoring Practices−'Good Grief! What Now?'", Nancy J Stark, 12 October 2010.
  "Good Monitoring Practices−Global Consensus", Nancy J Stark, 3 October 2010.
  "A Plan for Clinical Evaluation Reports, What Do Notified Bodies Want?", Nancy J Stark, 27 September 2010.
  "The Difficulties of Good Data Management", Nancy J Stark, 13 September 2010.
  "A Standard Development Tale: ISO/FDIS 14155 'Clinical Investigations of Medical Devices in Human Subjects−Good Clinical Practice' (2010)", Nancy J Stark 6 September 2010.
  "ISO/FDIS 14155 'Clinical Investigations of Medical Devices in Human Subjects−Good Clinical Practice (2010)'", Nancy J Stark, 24 August 2010.
  "Keeping Study Costs under Control; Building and Managing A Realistic Budget Plan", Nancy J Stark, 9 September 2010.
  "Risk Analysis Reports and EU Clinical Trials", Nancy J Stark, 27 July 2010.
  "The Critical Role of Risk Analyses in Clinical Investigations", Nancy J Stark, 13 July 2010.
  "The Clinical Research Process", Nancy J Stark, 12 July 2010.
  "Project Management of Medical Device Trials; Taking Control of the Process", Nancy J Stark, 7 July 2010.
  "Introduction to Medical Device Regulations: EU", Nancy J Stark, 23 June 2010.
  "Study Deviations and Amendments: US and ISO", Nancy J Stark, 18 June 2010.
  "The Difficulties of Good Data Management", Nancy J Stark, 17 June 2010.
  "Why Conduct Non-Inferiority Clinical Studies, Brief Comments on Missing Data", Nancy J Stark and Robert Thiel, 14 June 2010.
  "Protecting the Rights, Safety, and Welfare of Study Subjects−Supervisory Responsibilities of Investigators", Nancy J Stark, 13 May 2010.
  "The Latest in Canadian Device Regulations", Nancy J Stark, 3 May 2010.
  "What's Involved in Data Management?", Nancy J Stark, 4 March 2010.

2-Articles

Most of the articles published by Dr. Stark are available free from the publishers, others are available directly from CDG. If there is no link, please email us and request the article by full title and citation to assure you get the article(s) you want.

  Nancy J Stark, "US FDA Proposals on Risk-Based Clinical Trial Monitoring and Their Implications for Medical Device Manufacturers", Regulatory Affairs Medtech, in press.
  Nancy J Stark, "Data Management in Device Studies" Journal of Clinical Research Best Practices, (2011) Oct(7)10.
  Nancy J Stark and Daniel E McLain, "Medical Device Biocompatibility: Where to begin Biological Safety Testing", Regulatory Affairs Medtech (2011) July/August.
  Nancy J Stark, "Key Revisions to Medical Device Clinical Investigations Standard ISO 14155", Regulatory Affairs Medtech, (2011) May/June.
  Nancy J Stark, �?a href="mailto:cdginc@clinicaldevice.com?Subject=Please send me a copy of the article A New Standard for Medical Device Investigations">A New Standard for Medical Device Investigations�? Journal of Clinical Research Best Practices, (2011) Feb(7)1.
  Nancy J Stark, �?a href="http://www.firstclinical.com/journal/2011/1101_Device_Budget.pdf" target="_blank">Keeping Device Study Costs under Control: Building a Realistic Budget�?Journal of Clinical Research Best Practices, (2011) Jan (7)1.
  Nancy J Stark, "Clinical Evaluation Reports: The New Requirement”, Medical Device & Diagnostic Industry, (2010) Jan (32)1, p76.
  Nancy J Stark, "A New Standard for Medical Device Adverse Event Classification", Journal of Clinical Research Best Practices, Vol. 5, No. 12, December 2009.
  Nancy J Stark, and Baresch, J, "Exploring 30 Years of Preambles", Medical Device & Diagnostic Industry, (2009) June:58.
  Nancy J Stark, “Meeting US Rules on Clinical Trial Deviations�? Regulatory Affairs Journal, Devices(2008) Nov/Dec:16 p391.
  Nancy J Stark, “Clinical Trial Deviations�? The Journal of Biolaw and Business, (2008) Fall.
  Gertel, A, and Stark, NJ, “The World of Medical Devices−Serving Two Masters�? The Write Stuff, (2008) 17:2 p74.
  Nancy J Stark, “Best of Both Worlds: SOPs for Device Trials in Europe�? Regulatory Affairs Journal, Devices (2008) Mar/April:16 p85.
  Nancy J Stark �?a target="_blank" href="http://www.devicelink.com/mddi/archive/07/07/008.html">Best of Both Worlds: SOPs for Device Trials in Europe, Part 2�? Medical Device & Diagnostic Industry, (2007) July p82.
  Nancy J Stark, �?a target="_blank" href="http://www.devicelink.com/mddi/archive/07/05/009.html">Best of Both Worlds: SOPs for Device Trials in Europe, Part 1�? Medical Device & Diagnostic Industry, (2007) May p108.
  Nancy J Stark, "Outsourcing Clinical Research: A Comparison between the US and the EU" Regulatory Affairs Journal, Devices (2004) Jan/Feb:13.
  Nancy J Stark, "A Long Road: 25 Years of Clinical Research" Medical Device & Diagnostic Industry, (2004) August:96.
  Nancy J Stark, �?a target="_blank" href="http://www.mpo-mag.com/articles/2004/06/clinical-outsourcing-in-europe">Clinical Outsourcing in Europe�? Medical Products Outsourcing, (2004) June:64.
  Nancy J Stark, "Clinical Studies: Europe or the United States?", (2004) Medical Device & Diagnostic Industry, May:134.
  Nancy J Stark, “Understanding Biological Safety�?/a>, Medical Device Technology, September, (2002) Volume 13(7): 28.
  Nancy J Stark, "Manager's Series: Biological Evaluations of Medical Devices−Part 1, Evaluation", (2002), MedSpark, July 02.
  Nancy J Stark, "HIPPA & EU Data Protection--the Dos and Dont's of Privacy", (2002) Clinica, June 5:1010.
  Nancy J Stark, "Meeting the Requirements of the Personal Data Protection Directive Through HIPAA Privacy Rules" (2001), MedSpark Dec:1.
  Nancy J Stark, and Heath, E, "Incorporating the New HIPAA Privacy Rules into Medical Device Trials", (2001), Medical Device & Diagnostic Industry,July:114.
  Nancy J Stark, "Clinical Research in the Product Development Cycle", (2001)Medical Device & Diagnostic Industry, May:150.
  Nancy J Stark, "Prufzentren - Management bei klinischen Studien", (2000) Deutsche Zeitschrift fur Klinische Forschung, August:29.
  Nancy J Stark, "Clinical Trials for Medical Devices, Information for Investigators", (2000) The Monitor, Volume 14:1, Spring.
  Nancy J Stark, Rasmussen P, Spencer H, "Clinical Trial Site Management", (1999) Global CONTACT, Number 21:31.
  Nancy J Stark, "Managing Adverse Events and Effects during Clinical Trials", (1999) Medical Device & Diagnostic Industry, July:88.
  Nancy J Stark, "Conducting Health-Based Risk Assessments of Medical Materials", (1998) Medical Plastics and Biomaterials, September/October, 5(5):18.
  Nancy J Stark "Requirements for Clinical Trials for Medical Devices", (1997) Technology News, American Medical Association, April:1.
  Nancy J Stark, "Using Data Obtained Overseas for FDA Approval", (1997) Applied Clinical Trials, September:38.
  Nancy J Stark, "Software Can Help Manage Clinical Trials", (1997) Medical Device & Diagnostic Industry April.
  Nancy J Stark, "The Clinical Research Industry: New Options for Medical Device Manufacturers", (1997) Medical Device & Diagnostic Industry, January:215.
  Nancy J Stark, "Clinical Trials for Medical Devices, An Introduction", (1997) Applied Clinical Trials, January:34.
  Nancy J Stark, "Clinical Research for CEOs: A Guide to Good Business Practice and the Conduct of Clinical Trials", (1996) Clinica, 736/737:17.
  Nancy J Stark, "The Biological Safety of Nitinol: A Case Study in New Material Evaluation" (1996) The Validation Consultant, 3(9):8.
  Nancy J Stark, "Managing Positive Biocompatibility Test Results", (1996) Medical Device & Diagnostic Industry, 18(10):148.
  Nancy J Stark, "Introduction to Monitoring", (1996) Applied Clinical Trials, 5(5):34-40.
  Nancy J Stark, "Literature Report: Biological Safety of Parylene C", (1996) Medical Plastics and Biomaterials, 3(2):30.
  Nancy J Stark, "Designing Clinical Trials for Business and Marketing Needs", (1995) The Booth Validator, 2(1):3.
  Nancy J Stark, "Documenting Test Material Characterization", (1994) Medical Plastics and Biomaterials, 1(2): 50-55.
  Nancy J Stark, "Biocompatibility Management: A Quality System for Biological Safety", (1994) Medical Device & Diagnostic Industry, 16(3):92-100.
  Nancy J Stark, "Standard Operating Procedures and Biological Safety Testing", (1994) Medical Device & Diagnostic Industry, 16(5):238-242.
  Nancy J Stark, "How to Reorganize a Clinical Research Department", (1992) Medical Device & Diagnostic Industry, 14(6):154-159.
  Nancy J Stark, "A Chemist's View of Biocompatibility", (1991) Medical Device & Diagnostic Industry, 13(5):86-93.
  Nancy J Stark, "How to Organize a Biocompatibility Testing Program: A Case Study", (1991) Medical Device & Diagnostic Industry, 13(6):68-75.
  Nancy J Stark, "A Context for Clinical Research" (guest editorial), (1986) Medical Device & Diagnostic Industry, 8:10.

3-Books

CDG has a series of books, quality systems, and handy tools to make device pre-approval work a little easier. The links below will take you to our products page where everything is available.

Nancy J Stark, Clinical Research Quality System, Fourth Edition (1996, 2001, 2006, 2009), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Clinical Trials Design: Evaluation for Medical Devices, Second Edition 2002), Scientist Sha, Tokyo, Japan. (Translation into Japanese arranged by Japan Uni Agency, Tokyo, Japan, 2004).
  Nancy J Stark, Biocompatibility Testing & Management, (1996, 1998, 2003), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Clinical Trials Design (1996, 2000), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Project Management, (1999, 2003), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Applied Regulations, (200, 2004), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Good Monitoring Practices (1996, 2004, Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, CRA Handbook (1995, 1998, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2009, 2010, 2011), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Investigator's Guide to Clinical Research (2002), Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Investigator Handbook: On-Site Organization and Management (1997) Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Editor, (2002, 2005) Clinical Device Group Inc, Chicago, IL.
  Nancy J Stark, Editor, US Guidances for Clinical Research (2002, 2005, 2009).
  Nancy J Stark, International Clinical Trials, (1996, 1998) Clinical Device Group Inc, Chicago, IL.

3-Tools

  Date Wheel, (1998, 2008) Clinical Device Group Inc, Chicago, IL.
  Adverse Event Wheel, (2008) Clinical Device Group Inc, Chicago, IL.
  Certified Copy Stamp, (2008) Clinical Device Group Inc, Chicago, IL.
  Biocompatibility Text Matrix—Mouse Pad and Note Pad (2010) Clinical Device Group Inc, Chicago, IL.
  Adverse Events & Effects—Mouse Pad and Note Pad (2010) Clinical Device Group Inc, Chicago, IL.

4-Invited Presentations

Dr. Stark has given many presentations over the years. The pdf slides are available for your personal use at no cost unless otherwise notated, all you need do is ask. Please email us with the full title and citation to assure you get the slides you need.

Nancy J Stark, "Introduction to Medical Device Clinical Trials”, Northwestern University, 8 March 2010.
  Nancy J Stark, "Clinical Trials: What to Do and How to Do It”, MDM Rosemont Conference & Exhibition, Rosemont, IL, 24 September 09.
  Nancy J Stark, "Medical Device Adverse Events", Global ACRP Meeting, Seattle, WA, 22 April 07.
  Nancy J Stark, “From Claims to Protocols�? Regional RAPS Meeting, Chicago, IL, 29 Sept 05.
  Nancy J Stark, “Project Management for Medical Device Trials�? two-day training at MedicoIndustrien, Copenhagen, Denmark, 15-16 Sept 05. (Not available.)
  Nancy J Stark, “Biocompatibility Testing & Management�? two-day training at MedicoIndustrien, Copenhagen, Denmark, 13-14 Sept 05. (Not available.)
  Nancy J Stark, "From Claims to Clinicals: How claims Set the Specifications for Your Protocol", 2nd Meeting of Japan Forum of Clinical Trials on Medical Devices, 3 Sept 05, Tokyo Japan.
  Nancy J Stark, “European Medical Device Regulation�? three-day training at FDA/CDRH, Washington, DC. 13-15 July 05. (Not available.)
  Nancy J Stark, "A Comparison of ISO 14155 and ICH-GCPs", Barnett/Paraxel Summit on Drug and Device Safety, 4 May 05, Philadelphia, MD.
  Nancy J Stark, "Data Management for Medical Devices: Confusion and Controversy" DIA Data Management Conference, 9 Nov 04, Amsterdam, The Netherlands.
  Nancy J Stark, “Device Clinical Trials in the European Union�? FDA/CDRH College, 27 April 04, Rockville, MD. (Not available.)
  Nancy J Stark, “Clinical Research Practices in the Device Industry,�?Center for Business Intelligence conference on Pre-clinical and Clinical Trials for Medical Device and Combination Products, 11-12 March 04, Minneapolis, MN.
  Nancy J Stark, “Regulated Databases: Navigating Computerized Systems Used in Clinical Trials�? Center for Business Intelligence conference on Pre-clinical and Clinical Trials for Medical Device and Combination Products, 11-12 March 04, Minneapolis, MN.
  Nancy J Stark, “Project Management for Clinical Research,�?ASQ New England, 18 Nov 03, Needham, MA.
  Nancy J Stark, Keynote Address: “Clinical Research Practices in the Device Industry�? ASQ New England, 18 Nov 03, Needham, MA.
  Nancy J Stark, “Basic Aspects and Principal Problems in the Management of a Clinical Study�? DIA Second Latin American Congress of Clinical Research, 29 Sep-1 Oct 03, Mexico City, Mexico.
  Nancy J Stark, “Clinical Databases and Part 11: The Regulated Database�? Orange County Regulatory Affairs Society, 4-5 June 03, Irvine, CA.
  Nancy J Stark, “Clinical Databases and Part 11: A Layman’s Primer to System Documentation�? DIA Device Conference, 24-25 Feb 03, San Francisco, CA.
  Nancy J Stark, "HIPPA Requirements and Their Effect on Clinical Research", RAPS Clinical Trials Conference. August 5-6, 2002, Washington, DC.
  Nancy J Stark, "Predicting the Future: Clinical Research in the United States", SoCRA, Minnesota Local Chapter, June 13, 2002, Minneapolis, MN.
  Nancy J Stark, "HIPPA&minusHealth Insurance Portability and Accountability Act", SoCRA, Minnesota Local Chapter, June 13, 2002, Minneapolis, MN.
  Nancy J Stark, "HIPPA&minusHealth Insurance Portability and Accountability Act", FDA/OCRA Educational Conference, June 3-4, 2002, Irvine, CA.
  Nancy J Stark, "Case Study: Dulce Devices Implementing ISO EN 14155-1 & 2", AAMI/FDA International Conference on Medical Device Standards and Regulation, March 27-28, 2002, McLean, Virginia.
  Nancy J Stark, "Current US Regulatory and Ethical Issues in Clinical Research", Regulatory Affairs Professionals Society, March 20, 2002, San Francisco, CA.
  Nancy J Stark, "Investigator Selection & Clinical Study Monitoring", Medical Alley, March 13-20, 2002, St. Paul, MN.
  Nancy J Stark, "Survey of Clinical Research Practices: Medical Device Industry", July 18, 2001, St. Paul, MN.
  Nancy J Stark, "Current Topics in Clinical Research", Biomedical Focus, July 18, 2001, St. Paul, MN.
  Nancy J Stark, “Device Clinical Trials in the European Union�? FDA/CDRH College, 21 June 01, Rockville, MD.
  Nancy J Stark, “Current Topics in Clinical Research�? Medical Design & Manufacturing East, 5 June 01, New York, NY.
  Nancy J Stark, "Clinical Trials for Medical Devices", Regulatory Affairs Professionals Society, October 2-4, 2000, Washington, DC.
  Nancy J Stark, "Managing Subject Risk in Device Trials", Association of Clinical Research Professionals, May 15-17, 2000, New Orleans, LA.
  Nancy J Stark, "Project Management: A Case Study," Institute for International Research Conference on Project Management for Research & Development and Clinical Research, February 23-25, 2000, Philadelphia, PA.
  Nancy J Stark, "Clinical Trial Site Management", Association of Clinical Research Professionals, April 21-24, 1999, Washington, DC.
  Nancy J Stark, "Clinical Trial Site Management", Biomedical Focus, July 20-22, 1998, Minneapolis, MN.
  Nancy J Stark, "Working with CROs", Biomedical Focus, July 20-22, 1998, Minneapolis, MN.
  Nancy J Stark, "Health-Based Risk Assessments", Biomedical Focus, July 20-22, 1998, Minneapolis, MN.
  Nancy J Stark, "Case Studies: Material Safety Reviews", Medical Design & Manufacturing East97, June 1-5, 1997, New York, NY.
  Nancy J Stark, "Using Foreign Clinical Data in US Submissions", International Business Communications Conference, August 15-16, 1996, Williamsburg, VA.
  Nancy J Stark, "Managing Positive Biological Safety Result", Biomedical Focus X, July 15-17, 1996, Minneapolis, MN.
  Nancy J Stark, "The Changing Clinical Research Industry: A Challenge for the Future", Biomedical Focus X, July 15-17, 1996, Minneapolis, MN.
  Nancy J Stark, "Managing Positive Biological Safety Results", Medical Design and Manufacturing West, February 6-8, 1996, Anaheim, CA.
  Nancy J Stark, "Policies of Quality and Management in Cosmetic Dermatology", International Society of Cosmetic Dermatology, October 26, 1995, Montecatini Terme, Italy.
  Nancy J Stark, "Solving Quality Problems in Biocompatibility Management", Session Chair, Medical Design and Manufacturing East, May 24-26, 1994, New York City, NJ.
  Nancy J Stark, "Identity Documentation for Materials", Medical Design and Manufacturing East, May 24-26, 1994, New York City, NJ.
  Nancy J Stark, "Materials and Surveillance Screening&minusWhy and How", Medical Design and Manufacturing East, May 25-27, 1993, New York City, NY.
  Nancy J Stark, "Biological Safety: Design and Planning Issues", Biomedical Focus VI Conference and Exposition, July 27-29, 1992, Bloomington, MN.
  Nancy J Stark, "Materials Screening&minusWhy and How", Medical Design and Manufacturing West, February 4-6, 1992, Anaheim, CA.

5-Web Presentations

Web presentations are either 5-hour webinars (aka workshops) or 90-minute e-conferences. Both are available on our Webinar or e-Conference pages. Some older e-conferences have been dropped from the sales list but are available by special request.

  "Risk-Based Monitoring for Device Trials", Courses on CD, Nancy J Stark, 26 November 2011.
  "Introduction to ISO 14155", CDG Workshop Series, Nancy J Stark, 20 August 2011.
  "Good Monitoring Practices Workshop”, CDG Workshop Series, Nancy J Stark, 10 February 2010.
  "Good Protocol Design Workshop”, CDG Workshop Series, Nancy J Stark, 13 January 2010.
  "IDE Workshop”, CDG Workshop Series, Nancy J Stark, 16 December 2009.
  "Registry Basics for Medical Devices”, CDG e-Conference Series, Nancy J Stark, 18 November 2009.
  "The New ISO/DIS 14155 (2009)”, CDG e-Conference Series, Nancy J Stark, 14 October 2009
  "IDE Workshop" CDG Workshop Series, Nancy J Stark, 19 August 09.
  "Twelve Mistakes Monitors Manage", Nancy J Stark, CDG eConference Series, 15 July 09.
  "Project Management Workshop", Workshop Series, Nancy J Stark, 17 June 09.
  "Adverse Event Workshop", CDG Workshop Series, Nancy J Stark, 13 May 09.
  "Adverse Event Workshop", CDG Workshop Series, Nancy J Stark, 15 April 09.
  "Quality Systems Workshop", CDG Workshop Series, Nancy J Stark, 11 February 09.
  "Protocol Design Workshop, CDG Workshop Series, Nancy J Stark, 10 December 08.
  "ISO/DIS 14155 (2008) Clinical Investigations of Medical Devices in Human Subjects - Good Clinical Practices", CDG conference series, Nancy J Stark, 29 October 08.
  "Regulatory Permissions Workshop", CDG Workshop Series, Nancy J. Stark, 15 October 08.
  "Adverse Event Workshop", CDG Workshop Series, Nancy J Stark, 17 September 08.
  "Good Monitoring PracticesWorkshop", CDG Workshop Series, Nancy J Stark, 27 August 08.
  "Protocol Deviations Workshop”, CDG Workshop Series, Nancy J Stark, 23 July 08.
  "Adverse Event Workshop", CDG Workshop Series, Nancy J Stark, 16 June 08.
  "Adverse Event Workshop”, CDG Workshop Series, Nancy J Stark, 24 April 08.
  "Regulatory Permissions Workshop", CDG Workshop Series, Nancy J. Stark, 14 May 08.
  "Good Monitoring PracticesWorkshop", CDG Workshop Series, Nancy J Stark, 7 March 08.
  "Regulatory Permissions Workshop”, CDG Workshop Series, Nancy J Stark, 11 April 08.
  "What's Special about Diagnostic Trials?" CDG eConference Series, Michelle Secic and Nancy J Stark, 6 Mar 07.
  "Designing Paper-Based Case Report Forms” CDG eConference Series, Nancy J Stark, 27 Feb 07.
  "ISO or ICH—Which One for You?” FOI Services audio-conference, Ken Schiff and Nancy J Stark, 30 Aug 06.
  "Starting in Europe", Nancy J Stark, July 2004
  "What’s Up with Monitoring and the FDA?”, Nancy J Stark, June 2004.
  "Clinical Databases and Part 11: The Regulated Database”, FOI Online, Nancy J Stark, 27 June 2004.
  "Quality Systems for Clinical Research”, CDG eConference Series, Nancy J Stark, May 2006.
  "Survey of Clinical Research Practices in the Medical Device Industry", Nancy J Stark, Jan, 2004.
  "Clinical Databases and Part 11: Designing Case Report Forms", Nancy J Stark, 5 Sep, 2003.
  "ISO/FDSI 10993-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity - A Manager's Quiz", Nancy J Stark, July 15, 2003.
  "Clinical Databases and Part 11: A Beginner’s Walk through Part 11”, Nancy J Stark, May 2, 2003.
  "Clinical Databases and Part 11: The Regulated Database”, FOI Online, Nancy J Stark, April 24, 2003.
  "Survey of Clinical Research Practices in the Medical Device Industry", Nancy J Stark, Jan 2002.
  "HIPPA&minusSecurity and Privacy Impact on Clinical Research", Nancy J Stark, July, 2002.    "ISO 10993&minusBiological Evaluation of Medical Devices: A Manager's Quiz", Nancy J Stark, May 28, 2002.
  "Predicting the Future: Clinical Research in the US", Nancy J Stark, March 22, 2002.
  "Declaration of Helsinki&minusControversies with Revisions 2000", Nancy J Stark, Oct 31, 2001.
  "Survey of Clinical Research Practices in the Medical Device Industry", Nancy J Stark, Aug 18, 2001.

6-Academic Research

Prior to her career in industry, Dr. Stark did academic research for her doctoral and post-doctoral work. The resulting publications are available from the publishers.

Nancy J Stark, Levy GN Rohr, TE, Anderson JS, "Reactions of Second Stage of Biosynthesis of Teichuronic Acid of Micrococcus lysodeikticus Cell Walls”, The Journal of Biological Che-mistry, (1977) May (252):10 p3466.
Rohr TE, Levy GN, Stark NJ, Anderson JS, "Initial Reactions in Biosynthesis of Teichuronic Acid of Micrococcus lysodeikticus Cell Walls”, The Journal of Biological Chemistry, (1977) May (252):10 p3460.

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