Monitoring

For research quality control, monitoring plans appropriate to research designs are prepared, and centralized monitoring, on-site monitoring, etc. are carried out.

Service details

• Data input to electronic data capture (EDC) system
• Monitoring of essential documents

Participating Sites Support

Support for submissions to the Ethics Review Committee, and research contracts, are coordinated with the participating institutions. In addition, start-up meetings are held, test materials and operations are coordinated, and explanations are given about research protocols and methods. Other necessary coordinations are made.

Service details

• Preparation of documents for ethics committees at each institution
• Support for tasks associated with contract procedures
• Start-up
• Preparation of principal investigator files and case files
• Coordination of SOPs, etc. between institutions

Data Center

EDC system is constructed for collecting subject registrations and survey items.

Service details

• Preparation of procedures
• Preparation of case report forms.
• Construction and operation of EDC system
• Data management operation
• Help desk responses
• Handling centralized monitoring
• Data management report preparation and other responses on completion of tasks

Subject registration

• Preparation of procedures
• Construction and operation of subject registration system
• Construction and operation of subject registration and allocation system
• Judgment about eligibility, notification about enrollment results

Statistical analysis

• Preparation of statistical analysis protocol
• Program preparation
• Construction of analysis data set and output program
• Construction of figure and table output program
• Handling of Interim reports
• Preparation of deliverable product, and other measures, at completion of statistical analysis

Auditing

For research quality assurance, audits are carried out in accordance with the audit protocol.