Scheduled as Needed based on Student Demand. Email us at onlinetrain@nortonaudits.com if you are interested in this course.
Description - This is an advanced-level class that takes an in-depth examination of severe noncompliance, clinical data fabrication and falsification, scientific misconduct and fraud cases. The course focus is on developing skills for preventing fraud and misconduct and preparing clinical research professionals to better handle severe noncompliance.
Class Agenda/Modules - Instructors Make a Difference
Defining Clinical Research Fraud and Misconduct
Evaluation of Case History
R.E.S.E.A.R.C.H. TM Skills Program
Advanced Auditing and Monitoring Skills for Prevention
Case Development
Typical Class Attendee -
Sponsor Auditors
Contract Research Organization Auditors
Clinical Research Associates and Monitors
Institutional Review Board Internal Auditors
Food and Drug Administration Investigators
Independent Consultant Auditors
Compliance Auditors
Experience Level - Advanced; CRC, CRA or Auditor position for two years, preferably with a four year medical or science degree
Class Price - $1500 (10% Southeast Regional Discount and 10% multiple persons from the same organization discounts are available)
Norton: Donald Roberts, "Scientific Fraud", and DDT
In this piece Roger Bate, Donald Roberts and Richard Tren accuse the UN of "Scientific Fraud against DDT". Their Accusation is based on an Opinion paper byRoberts and Tren published in Research and Reports in Tropical Medicine. So let's look at their paper and see where the "Scientific Fraud" is.
Roberts and Tren's key argument is that reductions in malaria in the Americas were not the result of Global Environmental Facility interventions but were caused by increased use of antimalarial drugs. In their own words:
"However, their successes were not a result of the interventions we describe as components of the GEF project. Their successes were mostly a result of wide distributions of antimalarial drugs to suppress malaria (see Table 1). Data in the Table reveal trends of increased numbers of antimalarial pills distributed per diagnosed case and decreased numbers of cases. Equally obvious is the decreased numbers of pills distributed per diagnosed case, and increased numbers of cases in two countries (Costa Rica and Panama)."
So their argument rests on table 1. Here's table 1.
Country pills/case pills/case % change in % change in 1990 in 2004 pills/case in cases Mexico 235 2566 1092 -1307 Belize 21 82 390 -287 Costa Rica 653 100 -653 112 El Salvador 34 22802 67064 -8276 Guatemala 38 54 142 -144 Honduras 30 51 170 -338 Nicaragua 279 1319 473 -519 Panama 202 140 -144 1337
The first thing that leaps out at you is that the table shows reductions of more than 100%, which is impossible. Panama cannot have experienced a decrease of 144% in pills/case. According to the two previous columns in the table there was a decrease from 202 to 140, which is a 31% reduction, not 144%. 202/140 is 144%, but it is not the case that the column contains the ratio of pill/case in 1990 divided by pills/case in 2004 (ie, is just labelled wrongly), because then the number for Guatemala would be 70%, not the 142% shown in the table. The column appears to show the bigger number divided by the smaller. That is, all the percent changes in that column are calculated incorrectly and the increases and decrease were calculated differently.
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