Discussion about archive management for drug clinical trials
10.3760/cma.j.issn.1006-1924.2009.03.020
- VernacularTitle:药物临床试验档案管理探讨
- Author:
Songren QI
;
Ruihua SUN
- Publication Type:Journal Article
- Keywords:
Drug clinical trial;
Management of archives
- From:
Chinese Journal of Medical Science Research Management
2009;22(3):179-181
- CountryChina
- Language:Chinese
-
Abstract:
This article elaborated on the importance of collecting archives of drug clinical trails. Taking the drug clinical trial archives into account, the first value is the effort of clinical researchers. Sec-ond, the archives of drug clinical trials are the requirement to obtaining the evaluation before the new drug projects are approved. Third, the archives are the important evidence as getting professional certification from relevant drug research organizations and governmental officials. Making good drug clinical archive man-agement depends on the system and relevant regulations. A system should clarify the responsibilities of the collectors and managers for the archival materials. It also should make clear what are needs for collection, the rule of project numbering, and the rule of transferring. A good system also establishes the functionalities of monitoring and controlling. Last, the article pointed out the usual problem appeared in archive manage-ment of drug clinical trials.
