Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The fifth installment in our Clinical Research 101 series is by Leslie Love, Senior Project Manager at CHÉOS. The following is a brief summary of sponsor responsibilities in a clinical trial. For more detailed information see Health Canada’s guidance document on Good Clinical Practice (GCP).
Ms. Love is a certified clinical research professional with over 20 years of experience in a variety of research settings. Her primary role is to provide project management support to CHÉOS and Canadian HIV Trials Network-supported investigators, as well as develop research training materials and programs. Ms. Love is one of many project managers who work for CHÉOS. The Centre’s project managers are experts in the regulatory, policy, budgeting, and implementation requirements for clinical research studies. If you would like to inquire about our services, please submit your request here.
Note that the ICH GCP guidelines have been updated — and are referenced here — but are not yet implemented by Health Canada. Health Canada expects to fully implement the ICH GCP E6 (R2) in April 2018.
What is a sponsor in a clinical trial?
The sponsor is an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial, but typically does not conduct the study. A sponsor can also be a sponsor-investigator, who is an individual who both initiates and conducts a clinical trial. The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. To read about investigator responsibilities, see our previous post, Investigator Responsibilities 101.
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.
Selecting qualified investigators and providing them with all documents needed to conduct the trial.
Submitting clinical trial applications and amendments to Health Canada, and other regulatory agencies as applicable.
Ensuring all required ethics review and approvals are obtained.
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.
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. For more information, see our earlier post Clinical Trial Monitoring 101.
Note that a sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organization (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
Health Canada Guidance Document: Good Clinical Practice
International Council for Hamonisation of Technical Requirements for Pharmaceuticals for Human Use: Guideline for Good Clinical Practice
Clinical trials: Sponsors and sponsor-investigators (MaRS)