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List of Publications
List of Publications
New Book
D. Mackintosh, V. Molloy, and M. Mathieu, Good Clinical Practice: A Question and Answer Reference Guide. Media, PA: Barnett International, June 2003.
This book has 300+ answers to the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drug, biologics, diagnostics, and device trials. It also contains FDA, ICH, and EU GCP-related regulations and guidance documents. For more information, go to:
http://www.e-directlogic.com/Barnett/B01717.asp?e (on the Internet).
Journal Articles
D. Mackintosh, "Building Quality Assurance into Clinical Trials." Applied Clinical Trials 2:42-49, April, 1993.
D. Mackintosh, "Quality Assurance of Data Management and Statistical Analysis." Applied Clinical Trials 3:40-50, June, 1994.
D. Mackintosh and V. Zepp, "Getting a Better Deal: Unbundled CRO Prices." Drug Information Journal 29(4):1175-80, 1995.
V. Zepp and D. Mackintosh, "Source Documentation: A Key to GCP Compliance in Clinical Trials." Applied Clinical Trials 5:42-46, March, 1996.
D. Mackintosh and V. Zepp, "Detection of Gross Negligence, Fraud, and Other Bad Faith Efforts During Field Auditing of Clinical Trial Sites." Drug Information Journal 30(3): 645-653, 1996.
D. Mackintosh and V. Zepp, "GCP Responsibilities of Principal Investigators: Beyond the 1572. Applied Clinical Trials 5:32-40, November, 1996.
D. Mackintosh and V. Zepp, "Improving the Quality of Monitoring: Clinical Auditors' Observations." Applied Clinical Trials 6:52-58, September, 1997.
D. Mackintosh and V. Molloy, "Rapid Turnaround of Clinical Site Audit Reports Using Laptops, Off-the-Shelf Software, and E-mail." Applied Clinical Trials 8:56-61, March, 1998.
D. Mackintosh and V. Molloy, "Guarding the Pharmaceutical Chicken Coop: The Case for External Clinical Auditors," Good Clinical Practice Journal 5(3):8-12, May/June, 1998.
V. Molloy and D. Mackintosh, "Clinical Auditors Offer GCP Advice." The Monitor, Summer, 1999, pp 25-27.
D. Mackintosh and V. Molloy, "Conducting a Clinical Department Process Audit: Methodology and Findings." Drug Information Journal 33:1011-24, 1999.
Mackintosh, D., Editorial "Ethics Committees Do Not Sufficiently Protect Research Subjects." European Pharmaceutical Contractor, August, 1999, pp 16-17.
V. Molloy and D. Mackintosh, "Source Documentation: Clinical Auditors' Observations." Chapter in The Clinical Audit in Pharmaceutical Development, Michael R. Hamrell, PhD, Editor, New York Marcel Dekker, 2000.
Mackintosh, D., Molloy, V. and DeCherney, G.S., "GCP Responsibilities of Principal Investigators Revisited: Going Far Beyond the 1572." Applied Clinical Trials 9:59-64, March 2000.
V. Molloy and D. Mackintosh, "Physical Exams in Clinical Trials." Applied Clinical Trials 9:38-44 October 2000.
D. Mackintosh and V. Molloy, "Differences in Clinical Trial Conduct in US and EU Investigational Sites." Qual Assur J 5:13-17, 2001.
Mackintosh, D. "Year 2000 Revisions to the Declaration of Helsinki: Bye Bye Placebos." Applied Clinical Trials 10:46-7, April 2001.
D. Mackintosh and V. Molloy, "Zen and the Art of Clinical Site Auditing." Good Clinical Practice Journal 8:11-17, October 2001.
D. Mackintosh, V. Molloy, and M. Petty. "Identifying and Documenting Adverse Events at Clinical Study Sites." Applied Clinical Trials 11: 52-62, May 2002.
D. Mackintosh and V. Molloy. "10 Steps for Improving FDA GCP Inspections." Applied Clinical Trials 11: 44-48, June 2002.
D. Mackintosh and V. Molloy. "Opportunities to Improve Informed Consent: Frequently Observed Problems in Processes and Content." Applied Clinical Trials 12: 42-48, May 2003.
GCPA would be happy to send you reprints of these publications. Send us an e-mail (Contact the Staff) and indicate which articles you would like. Single reprints are free. Multiple copies of the same article are $1.15 per reprint plus postage. Please e-mail us the following information:
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