Talking about the Key Points and Notices of Drug Management in Clinical Trials
- VernacularTitle:浅谈临床试验中药物管理要点及注意事项
- Author:
Jiangchuan XIE
1
;
Wei GUO
1
;
Linli XIE
1
;
Minghong LI
1
;
Xinmei PAN
1
;
Liya CAO
1
;
Yongchuan CHEN
1
Author Information
1. Dept. of Pharmacy，the First Affiliated Hospital of Army Medical University，Chongqing 400038，China
- Publication Type:Journal Article
- Keywords:
Drug clinical trial;
Trial drugs;
Management;
Good Clinical Practice
- From:
China Pharmacy
2019;30(21):2894-2898
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To provide references for improving the standard operating procedures of drug management in clinical trials and drug management in clinical trials. METHODS： According to Good Clinical Practice （GCP）， Data On-site Verification Points of Drugs Clinical Trial， Qualification Examination Rules of Drug Clinical Trial Institution， based on the quality control project carried out in our hospital since July 2016， the matters needing attention in the non-standard operation and key process of drug management in clinical trial were summarized， and the improvement measures were discussed. RESULTS & CONCLUSIONS： Non-standard drug management is a high-incidence link of non-standard operation in the trial process. Among them， the acceptance， distribution and use of drugs are the three links with the highest incidence of non-standard operation of drug management in the trial process. Therefore， when formulating the relevant management system， each institution should pay attention to it according to its own situation； such as， when accepting drugs in clinical trials， attention should be paid to checking the intact degree of drug packaging； drugs transported in cold chain should also be checked for temperature records and rejected in case of over-temperature； the copies of the waybill should be kept in file with the original to avoid fading of the thermosensitive paper； whether the relevant characteristics of the control drugs and placebos meet the requirements. Institutions can standardize the key links of drug management in the trial process， the time of project establishment， project start-up， quality control and supervision， formulate and constantly improve the relevant drug management system and standard operating procedures （SOP）. For example， when starting a project， attention should be paid to the participation of drug administrators in the training and signature of start-up meeting， whether the design of the form is complete， standardized and operable. It is necessary for clinical trial institutions to pay attention to the standardization and precision of drug management and the key links in clinical trials.
