During the period from June 1977 to 31 December 1999, the number of study-orientated inspections and investigator orientated inspections represented 97% and 3%, respectively. The predominant clinical investigator deficiency categories for both USA and non-USA sites conducted during the fiscal years 1997-99 are described in Figure 7.7.
The FDA requires strict adherence by investigators to the protocol and documentation of data to show that the patients have met the protocol inclusion criteria and to permit evaluation of treatment response as well as a review of untoward adverse events. In the most serious cases, the failure to comply with the described protocol as approved by the institutional review
Protocol Records Consent Drug Acct Category
Figure 7.7 Clinical investigator deficiency categories, 1997-99.
board and submitted to the FDA may lead to rejection of data by the FDA and other regulatory agencies. In cases where the patient has been injured as a result of protocol violations, criminal prosecution can be initiated against the sponsor and/or investigator. Box 7.2 gives examples of protocol violations.
When deficiencies are identified by the FDA, a regulatory letter is sent to the investigator and the sponsor is advised that significant deviations from regulations were identified that require prompt voluntary correction. The identification of regulatory deficiencies or protocol violations does not necessarily constitute scientific misconduct or fraud. In the most serious regulatory deficiencies, the FDA may use one or more of the following regulatory administrative actions:
• Issuing a warning letter, which requires an investigator and/or sponsor response within 15 working days
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