My Recent Articles
A list of recent publications that may be of interest..
Walters, KA & Hamrell, MR. Consent Forms, Lower Reading Levels, and Using Flesch-Kincaid Readability Software. Drug Inform J. 42(4):385-394, 2008.
Gough, J & Hamrell, MR. Standard Operating Procedures (SOPs): Why You Must Have Them, and Why You Need Them. Drug Inform J. 43(1): 69-72, 2009.
Gough, J & Hamrell, MR. Standard Operating Procedures (SOPs): How Companies Can Determine which Documents They Must Put in Place. Drug Inform J. 44(1): 49-54, 2010.
Gough, J & Hamrell, MR. Standard Operating Procedures (SOPs): How to Write Them to Be Effective Tools. Drug Inform J. 44(3): 463-468, 2010.
Hamrell, MR. Raising Suspicions with the Food and Drug Administration: Detecting Misconduct. Sci Eng Ethics. 16:697-704, 2010.
Hamrell, MR. Global Good Clinical Practice Issues – Considerations from a Road Warrior, The ACRP Monitor. 26(4):61-63, 2012.
Look for these articles published in 2013
Hamrell, MR. Ethics and the Role of Humanitarian Devices, The ACRP Monitor, 27(5):13-15, 2013.
Mitchel, JT, Gittleman, D, Markowitz, JS, Suciu, L., and Hamrell, MR. 21st Century Approaches to QA Oversight of Clinical Trial Performance and Clinical Data Integrity. The ACRP Monitor, 27(6):41-46, 2013.
Hamrell, MR. FDA and Related Regulatory Agencies. In: Fundamentals of Regulatory Affairs, 8th edition. RAPS Press, pp. 1-10, 2013.
Mitchel, JT, Cho, T., Gittleman, D, Markowitz, Hamrell, MR, et. al., Time to Change the Clinical Monitoring Paradigm. Appl Clin Trials, Jan 2014.
Hamrell, MR., What is an IND? In: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics (D Pisano & D Mantus, eds), 3nd ed. Informa Healthcare Inc. in press, 2014.
Needham, MA, November 15, 2011 — Barnett International announced today that Michael Hamrell, President of MORIAH Consultants, will assume the role of lead editor of Barnett’s Good Clinical Practice, a Question & Answer Guide starting in 2012. Developed by Mark Mathieu of PAREXEL International Corporation, the title is a leading source of clarification for industry professionals responsible for navigating the nuances and the many emerging complexities of Good Clinical Practices compliance.
Look for the updated 2014 Edition in mid-year.