| 摘要 |
A method for evaluating drug study information to determine suitability of the drug study information for acceptance by a regulatory authority. The method includes receiving a drug study identification and study type, indicating whether the drug study is either (i) a nonclinical study that is intended to be a Good Laboratory Practice study, or (ii) a clinical study that is intended to support the efficacy indication of a drug that is the subject of the drug study information, and associating one or more checklists with the drug study. Each checklist has elements identifying one or more features to be identified in the drug study information, and a query to select a deficiency type from a predetermined list of deficiency types. The method receives the deficiency types and automatically assigns a criticality value to each based on the nature of the type of drug study. |
