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A serious adverse experience is any experience that suggests a 
significant hazard, contraindication, side effect or precaution. 
With respect to human clinical experiences, this includes any 
experience which: 
17.2.1.1 
17.2.1.2 
17.2.1.3 
17.2.1.4 
Is fatal or life-threatening; is permanently disabling 
(incapacitating or interfering with the ability to 
resume usual life patterns); requires in-patient 
hospitalization or prolongation hospitalization; is a 
congenital anomaly, cancer; or is an overdose. 
An unexpected adverse experience is any adverse 
experience that is unanticipated in nature, intensity, 
or frequency that may have potential relevance to 
the concept of the overall safety of the treatment. 
An overdose is a deliberate or inadvertent 
administration of a treatment at a dose higher than 
specified in the protocol and higher than known 
therapeutic doses. It must be reported irrespective 
of outcome; even if toxic effects were not observed. 
A death occurring during the study which comes to 
the attention of the investigator within four weeks 
after stopping the treatment (or at any time during 
the protocol-defined follow-up period), whether 
considered treatment-related or not, must be 
reported. 
17.3 Case Report Forms 
Case Report Forms (CRF) are used to record study data and are an integral part 
of the study and subsequent reports. Therefore, the reports must be legible and 
complete. All forms should be filled out using a black ball point pen. Errors 
should be lined out but not obliterated and the correction inserted, initialed, and 
dated by the principal or co-investigators. In the event errors are corrected by the 
data manager(s), follow the same procedure as above. In addition, however, one 
of the investigators must also initial these changes. 
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Recombinant DNA Research, Volume 15 
