Sponsor’s Responsibilities in Clinical Research

Although the specific regional requirements for a clinical trial sponsor can vary, generally, a sponsor is responsible for guaranteeing high-quality management of the trial, the sound rationale to justify the trial, the safety of the study subjects, appropriate data handing and system validation, compliance with regulations, and the contract research organisations’ duties for each of their clinical trials.
Sponsor’s Responsibilities Social Media Size Ncb

Sponsor's Responsibilities

Guidance for clinical trial sponsors on the key responsibilities of sponsors in clinical research.

 

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

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

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

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

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

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

Join our list and receive alerts for new resources!

clinicalnet

clinicalnet

Leave a Comment

Receive updates on our progress