ABSTRACT
After the completion of the pilot work of traditional Chinese medicine formula granules （TCMFGs）， the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work， this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards， mainly involving the executive standards and distinguishing technologies of raw materials， the adding process of excipients in the procedure item， the rationality of quality control methods， the information content and reproducibility of characteristic chromatograms， the nomenclature and accessibility of reference materials， etc. The common problems such as the coverage of standards， specification differences， and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards， accelerate the research and development of reference materials， advocate the use of high-quality raw materials， explore the evaluation methods of high-quality products， and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards， promote the continuous improvement of TCMFGs standard system， and ensure the healthy and orderly development of the TCMFGs industry.
ABSTRACT
Objective To acquire specific suggestions for improving the transparency of clinical research.Methods Summarize main challenges for transparency in clinical research,propose possible solutions.Results Currently the common practice of clinical research transparency is to promote study registration in the beginning phase,and reporting guildlines,data sharing in the end phase of the study.The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators,(2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process.To face the challenges,investigator should be more proactive and related research administration should be streamlined.Conclusions To improve the transparency of clinical research,better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened.Furthermore,advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management,it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals.Ultimately,full research transparency would be achieved.
ABSTRACT
Objective To develop a pathway management system for nucleus-related special service recuperation to enhance efficiency and extend function in the pathway management.Methods The system was developed on the basis of military sanatorium information management platform,and constructed with modular and object-oriented method,B/S mode,Oracle 8 database and Java programming languages.Results The system solved the problems of paper pathway management in time consumption,supervision,statistics,regulation and etc.Conclusion The system contributes to the standardization,convenience and precision of the pathway management for nucleus-related special service recuperation,and thus is worthy promoting in the nucleus-related military sanatorium.