Résumé
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.
Résumé
OBJECTIVE:To explore the method for the scientific and standard management of clinical trial drugs. METHODS:By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS:In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS:Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and im-prove information management continuously,which is of important significance to construct standardized,detailed and high-effi-ciency centralized management system of clinical trial drugs.
Résumé
This paper reports the results of a three-month randomized controlled trial toestimate the impact of an Internet and mobile telephone short messageservice (SMS) intervention on adolescents information about substances and rates of consumption. A low percentage of participants logged on to the Web platform, but most participants were reached through e-mails and SMS. It is found that the intervention was able to affect awareness that certain substances are drugs, but no significant changes in consumption habits were found.