Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Reproducibility of Results

Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.

In May 2005,resolutions on how cardia safety of a new drug should be monitored during its clinical studies were concluded with publication of an intensive International Conference on Harmonization(ICH) process,leading to the document: ICH Harmonized Tripatite Guideline: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiaahythmic drugs(ICH E 14).The review presented this guidance with commentary on areas requiring more clarifications that will be useful in developing China's strategies of cardiac safety programs of new drugs to ensure compliance with good clinical practice.

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.

Objective To explore the practical value of intracardiac echocardiography (ICE) on transcatheter closure of patent foramen ovale (PFO). Methods Eight-six patients with PFO were occluded using CardioSEAL under guidance of ICE. A diagnostic ICE was performed for imaging PFO anatomy and monitoring the closure procedure. Measurements of PFO tunnel diameter and length were made by ICE. The device deployment was evaluated by 2-D and color Doppler ICE after release, and then any residual shunt was detected by ICE agitated saline contrast study. Results ICE showed detailed anatomy of PFO and variations in morphology such as redundant secundum septum, convex secundum septum, tissue extension of primum into the fossa ovalis and hypertrophic limbus. Of 86 cases, 85 cases had successful implantation of the CardioSEAL, 1 case failed.Conclusions Transcatheter closure of PFO guided by ICE is a safe, effective, simple and less invasive solution.

Objective To investigate the preliminary experience of transcatheter closure of patent foramen ovale (PFO) under intracardiac echocardiographic (ICE) guidance and to compare the quantitative ICE data with fluoroscopy. Methods 86 patients with PFO were occluded by cardioSEAL~ under the guidance of ICE. Measurements of baseline PFO tunnel diameter and length were taken by ICE. Balloon stretch diameter (BSD) was measured by both ICE and fluoroscopy. The device deployment was guided and evaluated by 2-D and Color Doppler ICE during and after the procedure, and residual shunt was detected by ICE agitated saline contrast study. Results ICE showed detailed anatomy of PFO and the surrounding structures. The baseline PFO tunnel length and diameter measured by ICE were 11?4 mm (3.6-22 mm) and 4?2 mm (0-9 mm), respectively. BSD of PFO measured by ICE and fluoroscopy were 9.2?2.6 mm (5-16 mm) and 9.7?2.8 mm (5-17 mm), respectively. These BSDs showed excellent correlation (r=0.90, P

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

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.