Sponsor's Responsibilities
Guidance for clinical trial sponsors on the key responsibilities of sponsors in clinical research.
Quality Management
The sponsor should implement a system to manage quality throughout all stage of the clinical trial process. These include:
- Quality management system
- Quality assurance/control
- Qualified medical personnel
- Investigators training and experience
Science
The sponsor should guarantee that clinical trials are scientifically sound, described in a clear, detailed protocol, and allow identification of all the data reported for each subject.
- Research with sound scientific rationale
- Prepare study documents
- Unambiguous subject identification codes
Safety
The sponsor is responsible for the safety evaluation of the investigational product(s) in clinical trials by implementing or enforcing:
- Clinical trial amendments
- Study monitoring
- Management and reporting of adverse events
- Compensation and indemnity
Data Handling and System Validation
The sponsor should ensure appropriate data handing and validation of systems used in the clinical trial process by implementing or enforcing:
- System validation
- Subject protection and data integrity
- SOPs for management systems
- Data management, retention and reporting
Compliance
The sponsor is responsible for implementing and maintaining quality assurance and quality control systems used in the clinical trial by implementing or enforcing:
- Protocols, SOPs, GCP, regulatory and policies
- Root cause analysis (RCA)
- Corrective and preventive action plan (CAPA)
- Termination of investigator’s participation
Contract Research Organisations
A sponsor may transfer any or all of the sponsor’s clinical trial related duties and functions to a contract research organisation (CRO), but the ultimate responsibility for the quality and integrity of the clinical trial data always resides with the sponsor.
- Quality and data integrity
- Duties subcontracted to third party
- Sponsor oversight
- Transfer of study-related duties
