The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirements. The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
This topic describes: Contract Research Organization (CRO), Medical Expertise, Trial Design, Trial Management, Data Handling, and Record Keeping, Investigator Selection, Allocation of Responsibilities, Compensation to Subjects and Investigators, Financing, Notification/Submission to Regulatory Authority(ies), Manufacturing, Packaging, Labelling, and Coding Investigational Product(s), Record Access, Safety Information, Adverse Drug Reaction Reporting and Monitoring.