Risk assessment, prevention and control of drug clinical trial institutions / 肿瘤研究与临床

The management of drug clinical trial institutions from the risk management point of view is investigated. According to the technology of risk assessment in risk management, taking the project audit as an example, basing on the basic procedures of risk identification, risk assessment and risk control, making 8 risk factors into the table of risk management for project approval of clinical trial in order to initially establish a risk management of drug clinical trial institutions. In this way, the management quality of project for drug clinical trials will be probably improved, so that the risk incidence rate will be effectively reduced in the later phase of clinical trial.

Influence and Reflections on the Work of Drug Clinical Trial Institutions in China after Joining in ICH / 中国药房

OBJECTIVE： To summarize the problems and countermeasures which the construction of drug clinical trial institutions face after China Food and Drug Administration （CFDA） join in ICH， and its effects on clinical study management in China. METHODS： Combined with the experience on Good Clinical Practice （GCP） in our hospital during recent years， reviewing related content of ICH-GCP， the differences between China’s GCP （CFDA-GCP） and ICH-GCP， the problems faced by drug clinical trial institutions after joining in ICH， and the thinking of China’s clinical research were discussed. RESULTS & CONCLUSIONS： There were differences between CFDA-GCP and ICH-GCP in the management concept of clinical drug trials， the structure and function of ethical committees， the protection of the rights and interests of subjects， the choice of researchers and research institutions， management requirements of experimental drugs and the management of documents and data. After joining in ICH， the current organization and management structure， system and standard operating procedures， ethics committee， GCP training and continuing education， professional quality control system， experimental drug management， data management and information system construction and upgrading， clinical research coordinator management and other aspects of the drug clinical trial institutions were far from the requirements of ICH. The standardization of drug clinical trial institutions in China can be further promoted by revising regulations and guidelines， formulating standard operating procedures in line with ICH-GCP， building standardized ethics committees， implementing GCP training and continuing education， improving quality control system and drug management in clinical trials， strengthening hardware and software construction and clinical coordinator management， etc. At the same time， problems such as fewer full-time personnel and weak implementation of the system can be improved by strengthening project management， improving the quality of employees and building normal cross-regional cooperation.

Practice Experience of Pharmacy Drug Management in Drug Clinical Trial Institution of Our Hospital / 中国药房

OBJECTIVE:To promote the management of clinical trial drugs and to guarantee the quality of clinical trials. METHODS:According to the management regulatory requirements,in Good Clinical Practice(GCP)and Drug Clinical Trial In-stitution Qualification Review Inspection Standard for clinical trial drug the problems including hardware facilities,personnel and re-cording documents such as receiving,storing,dispensing and recycling for surplus drugs were reviewed,meanwhile,countermea-sures and relative suggestions were put forward. RESULTS & CONCLUSIONS:The hardware facilities and personnel meet the re-quirements of GCP,but many recording documents such as receiving,storing,dispensing and surplus drug recycling are incom-plete and should be improved in our hospital. Therefore,the improvement of the process of experimental drug flow management and the complement of record of the documents are established. And suggestions about the establishment of electronic drug manage-ment system,pharmacists to take an active part in the whole process of drug clinical trials intervention,the establishment of full-time pharmacist to manage the clinical trial drugs in the clinical trial institution pharmacy are put forward.

Clarifying the Responsibilities of Drug Clinical Trial Institution and Ethics Committee in China / 中国药房

OBJECTIVE:To clarify the responsibilities of drug clinical trial institution and ethics committee in China,and to provide reference for the improvement of drug clinical trial management. METHODS:The responsibility conflicts between drug clinical trial institution and ethics committee were summarized,and its reasons were analyzed to provide suggestions. RESULTS &CONCLUSIONS:The responsibility conflicts have been found between drug clinical trial institution and ethics committee,mainly manifesting as the essential person who submits protocol is not clear;the responsibilities in multicenter ethics investigation are con-troversial;the management of their track issues are not connected enough. 3 aspects of measures can be adopted,including reach-ing an agreement of responsibility assignment learning from foreign advanced ideas,improving laws and regulations;enhancing the management,promoting the implementation of policy and agreement. So,the responsibilities of drug clinical trial institution and ethics committee can be further clarified to improve the management of drug clinical trial.

Practice and Experience of Application and Report for the Accreditation of Drug Clinical Trial Institution Qualification of Our Hospital / 中国药房

OBJECTIVE:To introduce the experience of application and report for accreditation of drug clinical trial institution qualification of our hospital,to provide a reference for other hospitals. METHODS:From the building of institution,drug clinical trial ethics committee,clinical trials of listed drugs,simulated qualification accreditation,and other aspects,the experience and key points of application and report for accreditation of drug clinical trial qualification of our hospital were summed up. RESULTS& CONCLUSIONS:Priority should be given to staffing(particularly the leaders of the institution),the installation of software and hardware (for system development,training,institution office and specialized department),and the building of ethics committee. Departments should share work experience of clinical trials of listed drugs and set up a self-inspection group to simulate qualifica-tion accreditation. Work procedures and methods of qualification accreditation should be clearly understood,the requirements of Good Clinical Practice,the standards for qualification accreditation,should be known well;Good Clinical Practice should be seri-ously implemented and the subjects’rights and interests should be protected,which will contribute to the successful completion of application and report for qualification accreditation.

Construction and Management of Drug Clinical Trial Institution in Our Hospital / 中国药房

OBJECTIVE:To provide reference for the construction and management of hospital clinical drug trial institution. METHODS: The practice of our hospital in the construction and management of hospital clinical drug trial institution in accordance with the Good Clinical Practice and the Trial Provisions for Drug Clinical Trial Institution Qualification was summarized. RESULTS: Hospital attached great importance by taking effective measures,strengthening the construction of software and hardware and emphasizing reforming was the key to pass the qualification confirmation,and the key points in the management are to tighten control on the clinical trial process and establish complete management regulations. CONCLUSION: The construction and management of hospital clinical drug trial institution is conducive to the improvement of clinical trial level and it serves as a scientific,accurate and reliable basis for the evaluation and marketing approval of new drugs.