A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.
Clinical Trials as Topic ; Databases, Factual ; Documentation ; standards

OBJECTIVETo discuss the methods of implantable medical device supervision reform.

METHODSMethods of literature review, comparative study, the research of situation, developmental study and case study were adopted.

RESULTSIt is the untrue and asymmetric information of implantable medical device that results in improper behavior in the implantable medical device industry.

CONCLUSIONSA implantable medical device electronic monitoring system, namely establishing the independent but interrelated real-time dynamic updating of the databases, which would guarantee the information of implantable medical device is open and transparent, eliminate false food information transmission, vindicate the good order of domestic implantable medical device industry and protect the vital interests of the public.

The article overviews some achievements and problems of Korean medical journals published in the highly competitive journal environment. Activities of Korean Association of Medical Journal Editors (KAMJE) are viewed as instrumental for improving the quality of Korean articles, indexing large number of local journals in prestigious bibliographic databases and launching new abstract and citation tracking databases or platforms (eg KoreaMed, KoreaMed Synapse, the Western Pacific Regional Index Medicus [WPRIM]). KAMJE encourages its member journals to upgrade science editing standards and to legitimately increase citation rates, primarily by publishing more great articles with global influence. Experience gained by KAMJE and problems faced by Korean editors may have global implications.
Abstracting and Indexing as Topic ; Databases, Factual ; Humans ; Publishing/*standards ; Republic of Korea

In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods.
Databases, Factual ; Diagnostic Tests, Routine/*standards ; Humans ; ROC Curve ; Research

On the basis of real working practices in data normalization, the case reports from the monitoring system were studied, non-standard reports were summarized and the reasons were analyzed, the methods of data normalization and improving the reporting quality were discussed. The standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of new cases.
Databases, Factual ; Equipment and Supplies ; adverse effects ; standards ; Quality Control

PURPOSE: The purpose of this study was to evaluate the quality of meta-analysis regarding exercise using Assessment of Multiple Systematic Reviews (AMSTAR) as well as to compare effect size according to outcomes. METHODS: Electronic databases including the Korean Studies Information Service System (KISS), the National Assembly Library and the DBpia, HAKJISAand RISS4U for the dates 1990 to January 2014 were searched for 'meta-analysis' and 'exercise' in the fields of medical, nursing, physical therapy and physical exercise in Korea. AMSTAR was scored for quality assessment of the 33 articles included in the study. Data were analyzed using descriptive statistics, t-test, ANOVA and chi2-test. RESULTS: The mean score for AMSTAR evaluations was 4.18 (SD=1.78) and about 67% were classified at the low-quality level and 30% at the moderate-quality level. The scores of quality were statistically different by field of research, number of participants, number of databases, financial support and approval by IRB. The effect size that presented in individual studies were different by type of exercise in the applied intervention. CONCLUSION: This critical appraisal of meta-analysis published in various field that focused on exercise indicates that a guideline such as the PRISMA checklist should be strongly recommended for optimum reporting of meta-analysis across research fields.
Databases, Factual ; *Exercise ; Humans ; Publishing/*standards ; Republic of Korea ; Research

In order to support the theory and practice of the web-based cancer database development in China, we applied a systematic evaluation to assess the development condition of the web-based cancer databases at home and abroad. We performed computer-based retrieval of the Ovid-MEDLINE, Springerlink, EBSCOhost, Wiley Online Library and CNKI databases, the papers of which were published between Jan. 1995 and Dec. 2011, and retrieved the references of these papers by hand. We selected qualified papers according to the pre-established inclusion and exclusion criteria, and carried out information extraction and analysis of the papers. Eventually, searching the online database, we obtained 1244 papers, and checking the reference lists, we found other 19 articles. Thirty-one articles met the inclusion and exclusion criteria and we extracted the proofs and assessed them. Analyzing these evidences showed that the U.S.A. counted for 26% in the first place. Thirty-nine percent of these web-based cancer databases are comprehensive cancer databases. As for single cancer databases, breast cancer and prostatic cancer are on the top, both counting for 10% respectively. Thirty-two percent of the cancer database are associated with cancer gene information. For the technical applications, MySQL and PHP applied most widely, nearly 23% each.
Databases, Bibliographic ; Databases, Factual ; standards ; Humans ; Information Storage and Retrieval ; methods ; Internet ; Neoplasms ; Randomized Controlled Trials as Topic

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

The objective of this study was to conduct the systematic evaluation of methodological quality of clinical practice guidelines (CPGs) in Korea. The authors conducted a very comprehensive literature search to identify potential CPGs for evaluation. CPGs were selected which were consistent with a predetermined criteria. Four reviewers evaluated the quality of the CPGs using the Appraisal of Guidelines, Research and Evaluation (AGREE) Instrument. AGREE item scores and standardized domain scores were calculated. The inter-rater reliability of each domain was evaluated using the intra-class correlation coefficient (ICC). Consequently, 66 CPGs were selected and their quality evaluated. ICCs for CPG appraisal using the AGREE Instrument ranged from 0.626 to 0.877. Except for the "Scope and Purpose" and "Clarity and Presentation domains", 80% of CPGs scored less than 40 in all other domains. This review shows that many Korean research groups and academic societies have made considerable efforts to develop CPGs, and the number of CPGs has increased over time. However, the quality of CPGs in Korea were not good according to the AGREE Instrument evaluation. Therefore, we should make more of an effort to ensure the high quality of CPGs.
Databases, Factual ; Humans ; Practice Guidelines as Topic/*standards ; Quality Control ; Republic of Korea