Articles & Book Reviews

FDA GCP TMF protocol violations

Articles on GxP

Here are some articles I have written since leaving FDA in January 2005. They are, sort of, in chronological order. I try to look at issues including GCP Warning Letters, Protocol Violations or Deviations; Clinical Trials for FDA Regulated Products, the trial master file, the TMF, the FDA 1572, Statement of the Investigator and the FDA Bioresearch Monitoring Program. As always, I welcome your comments.

Guest post on SOP Writing Blog for Differences between FDA & EMA

The FDA 483-
The FDA 483

GCP Vendor Audits-

Bimo Trends 2008

BNA Bimo Trends Feb27_08

Supervisory Responsibilities of Sponsors-
BNA Article on Supervisory Responsibilites of CIs

Protocol adherence and Records-
Protocol Adherence and Recordkeeping

Notes to File-
ACT_NTF_March_08 Final

Quality Systems for Monitoring –
July 08_Anderson_RAPS Focus_Monitoring

Investigator Final Reports

Declaration of Helsinki-
GCPj Final Rule Non IND Trials


Special Notice: The Blog was published in the Journal of Diabetes Science & Technology on the topic of Supervisory Responsibilities of Investigators with my colleagues Ann Berenbaum and Patti Young.

Access the Abstract Here


Here are some book reviews about government, FDA, food, and drugs by Sid Olufs, a professor at Pacific Lutheran University- and don’t forget to check out Sid’s webpage on the Blogroll for
“FDA, Food Safety, and Related Topics.”

book reviews on FDA

A Book a Day

“The End of Overeating,” by David Kessler, MD

Paul L. Conkin, A Revolution Down on the Farm: The Transformation of American Agriculture Since 1929 (Lexington: The University Press of Kentucky, 2008).

“Doubt is Their Product,” by David Michaels
David Michaels, Doubt Is Their Product (NY- Oxford, 2008)

“Dangerous Doses: How Counterfeiters Are Contaminating America’s Drug Supply
rt, 2005), by Katherine Eban

Katherine Eban, Dangerous Doses-

The Waxman Report-
Henry Waxman, with Joshua Green, The Waxman Report-

A Question of Intent by Dr. David Kessler-

Genetically modified foods
Lisa H. Weasel, Food Fray- Inside the Controversy over Genetically Modified Food

The Unhealthy Truth: How Food is Making us Sick-
Review_Rachel Kranz, The Unhealthy Truth- How Our Food Is Making Us Sick

Three short reviews: Protecting America’s Health by Philip J. Hilts; Poison Pills: The Untold Story of the Vioxx Drug Scandal by Tom Nesi; and The Truth About the Drug Companies by Marcia Angell, (NY: Random
House, 2004):

Philip J. Hilts, Protecting America’s Health

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4 Responses to Articles & Book Reviews

  1. debra gilmore says:

    Attended your TMF presentation today.

    I cannot not open the final reports (investigator final reports_anderson_aug09). I was able to open the other reports. Can you send to me?


    • GxP Perspectives says:

      I will replace this version with something more user friendly. I sent you a PDF. Sorry for the inconvenience.

  2. George Orr says:


    We have a very rigid stance when it comes to defending a patient’s right to withdraw consent from all study participation, follow-up, etc. Most of the time patients withdraw consent to study treatment but they will agree to allow us to report survial status (we do oncology research and survival is an important end point to most of our studies). We have a few patients who withdraw all consent and tell us they want nothing else submittd to the sponsor. In those instances, we take a hard line to honor their wishes.

    We frequently get push back from sponsors trying to get us to continue to report survival against a patient’s wishes. I spoke to a couple of IRBs about this a few years ago and was left with the understanding that we should not submit that survival information. The sponsors try to circumvent our arguement by stating patients’ deaths are part of the Public Record, therefore at the very least we should be reporting deaths.

    Do you know of any good guidance on this? We fully understand the importance of the survival information but our thought is that we would rather err on the side of patient rights versus sponor needs.


    George Orr

    • GxP Perspectives says:

      I do not know of a guidance on this issue. My personal viewpoint is that you are correct and you should use the IRB of record’s directions on the issue. You can also ask this question at FDA’s GCP Questions email at:

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