美国国立卫生研究院(NIH)过敏和传染病研究所(NIAID)临床评估分级标准.doc

Note:? The following toxicity table is?a DRAFT and designed to?provide general guidance on?parameters?for monitoring safety in clinical trials.??This toxicity table?is not?comprehensive and should not be applied directly to all trials.?? ? When selecting a toxicity table, the following are some of the items that must be taken into consideration: ? The?population?being studied Does the clinical trial evaluate healthy subjects,?subjects?with a particular disease or condition?? The stage of test article development Is the clinical trial a Phase I, II, III or IV? The?type of?test article? Does the clinical trial evaluate a drug,?device,?vaccine or?other biologic agent?? The prior human and preclinical experience with the?test article Are there any specific findings that require adjustment of?the toxicity table?? ? Single site clinical trials evaluating healthy subjects should conform to the laboratory normal values at the single site. Multi-center clinical trials should reconcile among their laboratory normal values when evaluating a healthy volunteer population. ? Please confer with?the DMID protocol team and?DMIDs Office of Clinical Research Affairs?when selecting or developing a toxicity table for a DMID-sponsored trial. ABBREVIATIONS: Abbreviations utilized in the Table: ULN = Upper Limit of Normal LLN = Lower Limit of Normal Rx = Therapy Req = Required Mod = Moderate IV = Intravenous ADL = Activities of Daily Living Dec = Decreased ESTIMATING SEVERITY GRADE For abnormalities NOT found elsewhere in the Toxicity Tables use the scale below to estimate grade of severity: GRADE 1 Mild Transient or mild discomfort ( 48 hours); no medical intervention/therapy required GRADE 2 Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required GRADE 3 Severe Marked limitation in activity, some assist