Who is a Sponsor

 Who is a Sponsor?

• A Sponsor refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. 
• The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.

What are the responsibilities of a Sponsor?

    The sponsor is responsible for ensuring that the clinical study is conducted in accordance with the protocol, GCP, and applicable regulatory requirements. Specifically, the sponsor is responsible for:

Implementing a system to manage quality throughout all stages of the trial process. Sponsors should focus on trial activities essential to ensure protection of study participants and the reliability of trial results.

Quality Assurance and Quality Control:

    Implementing and maintaining quality assurance and quality control systems with written standards of practice to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).

Trial Design, Management, Data Handling, and Record Keeping:

    Supervising the overall conduct of the trial, to handle and verify the data, to conduct the statistical analyses, and to prepare the trial reports.

Investigator Selection:

    Selecting qualified investigators and providing them with all documents needed to conduct the trial.

Regulatory Authorities:

    Submitting clinical trial applications and amendments to Health Canada, and other regulatory agencies as applicable.

Research Ethics:

    Ensuring all required ethics review and approvals are obtained.

Investigational Products:

    Manufacturing, packaging, labelling Investigational Products (IP) according to Good Manufacturing Practices, and for supplying IP to the investigator(s). All labelling should follow local regulatory requirements.

Safety:
    Conducting ongoing safety evaluation of the investigational product and notifying all investigators and regulatory authorities of any findings that affect product or participant safety.

Monitoring and Auditing:
    Monitoring the study to ensure protection of study participants and the reliability of trial results. If monitoring or auditing identifies serious or persistent noncompliance, the sponsor must take immediate action to correct the issues. 

Note: A Sponsor Can transfer all responsibilities to Contract Research Organization (CRO). Once transferred, all references to “sponsor” will apply to the CRO.

Next: CRO