Essay Examples on Herguan University

Proposed Rule Disqualification of a Clinical Investigator

The Federal Register is an official journal of the United States government that consists of new regulations proposed rules and notices It is compiled by the Office of the Federal Register and published by the Government Publishing Office The Federal Register has a comment period during which the public can submit their views and comments about the Proposed Rules The FDA carefully scrutinizes these public comments and based on their analysis the FDA can either declare the rule or abandon its intention to declare a rule Disqualification of a Clinical Investigator is a rule proposed by the Food and Drug Administration on April 13 2011 1 The provision for disqualification of a Clinical Investigator is already a part of regulations 21 CFR Part 312 511 and 812 2 3 4 When disqualified an Investigator is ineligible to receive for the purpose of research any FDA regulated products such as drugs medical devices biologics foods animal drugs infant formulas tobacco products and food and color additives An investigator who is declared to be ineligible to receive these test articles under 21 CFR parts 312 511 or 812 will be ineligible to perform any clinical investigation or research The given Proposed Rule expands upon the scope of Clinical Investigator disqualification Its main intent is to ensure the integrity and dependability of clinical trial data The mission of the FDA is to protect public health The given rule if enforced will support the FDA in protection of subjects participating in clinical investigations The basis of this proposal is a study conducted by U S Government Accountability Office GAO that studied the FDA's oversight of Clinical Investigators who conducted research consisting of new devices biologics and drugs 5 On conducting the study GAO found that clinical investigators who were disqualified from receiving one type of investigational test product were able to serve as investigators for other kinds of test products According to current regulations the FDA can disqualify a clinical investigator if he is found to be engaged in misconduct that puts the safety of the study subjects at risk 

2 pages | 662 words