Sponsor responsibilities in Clinical Trial

Sponsor Responsibilities in clinical research as per ICH GCP E6

1. Sponsor Responsibilities and GCP Ashish Singh Parihar

2. (ICH) E6 Section 5 The sponsor is often a pharmaceutical company , but may also be an individual (the investigator), an academic institution, governmental agency, private organization, or other organization. The type of sponsor can vary from study to study, depending on who takes overall responsibility for the conduct of the trial. Who can be a sponsor ? Sponsor is not synonymous with Funder!

3. Sponsor : "An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial .“ Sponsor-Investigator : "An individual who both initiates and conducts , alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator." Definition of Sponsor

4. Implementing and maintaining a quality management system throughout all stages of the trial process. The quality management system should use a risk-based approach. Implementing and maintaining quality assurance and quality control systems. Those systems include written standard operating procedures ( SOPs ) to ensure that the studies are conducted in accordance with GCP, and are in compliance with applicable legal, ethical, and regulatory requirements Responsibilities In general, sponsor responsibilities include (but are not limited to):

5. Designating qualified medical personnel who will advise on study-related medical questions or problems. Often these qualified medical personnel are referred to as  medical monitors. Selecting investigators qualified by training and experience to properly conduct the study . Asking for curriculum vitaes ( CVs ), medical licenses and training certificates helps ensure qualified investigators (and study teams) are selected. Cont …

6. Ensuring the research has sound scientific rationale and principles . Preparation of documents (Investigator's Brochure, protocol, subject information and consent, case report forms, final report).

7. Providing investigator(s ) with the necessary information to conduct the study. Ensuring investigators are appropriately qualified, are trained on the protocol, and are committed to providing medical oversight for study subjects while understanding their role in relation to specific trial activities. Using unambiguous subject identification codes that allow identification of all the data reported for each subject.

8. Providing the investigational product(s ), as well as information to ensure the safe use of these products. Ensuring compliance with labelling , reporting, and recordkeeping requirements. Maintaining a system for the disposition of unused investigational product(s).

9. Ensuring all necessary ethics review(s) and approval(s) are obtained . Providing compensation and indemnity in the event of a study-related injury or death (according to local laws and regulations).

10. Safety Management and Reporting of applicable adverse events. Responsible for the ongoing safety evaluation of the investigational product. Setting up a data safety monitoring board (DSMB ) as required. Sending reports of all serious and unexpected adverse reactions to all investigators conducting clinical trials using the product and applicable regulatory authorities. Preparing periodic safety updates (revisions to the Investigator's Brochure) for review by applicable regulatory authorities.

11. Ensuring data management , record retention, reporting, and generation of study reports. Ensuring proper monitoring of the study. Selecting a monitor qualified by training and experience to monitor the progress of t he study. Preparing and submitting clinical trial application(s ) and a mendment( s) to the appropriate regulatory agencies.

12. A sponsor can transfer any or all of its study-related duties to a Contract Research Organization (CRO), however any such transfer should be documented in writing . The sponsor should ensure oversight of any study-related duties carried out on its behalf, even those duties subcontracted to another party by the sponsor’s CRO. Ultimately the responsibility for the quality and integrity of a study always resides with the sponsor. Imp. Points

13. As an investigator acting as a sponsor, the investigator is held to the same standards and obligations as any other individual or organization that takes responsibility for and initiates a clinical investigation Investigator-initiated studies are managed by the same regulations that apply to the sponsor initiated studies Investigator-Initiated Studies Where the Investigator is also the Sponsor

14. An investigator, regardless of the study type, is responsible for the proper and safe conduct of the study from initiation until the completion of the study. The sponsor-investigator is responsible to ensure compliance with all applicable regulations, legislation, and codes of ethics and GCP.

15. Study design Ensuring appropriate institutional, regulatory and ethics committee approval Study conduct, including responsibility for ensuring appropriate medical safeguards, adequate record keeping, medical monitoring, adverse event reporting, and medical supervision Analysis and interpretation of the results Communication of the results (for example, publications) When an investigator initiates a study and develops the protocol (alone or with others), and acts as the study sponsor, the investigator assumes responsibility for all aspects of the research, including:

16. Regulatory requirements Funding and budgeting Reporting Investigational Product Accountability Agreements, Insurance & Liability Ongoing safety evaluation of the investigational product(s) Quality Assurance Monitoring Auditing SOPs Multi- centre or international studies Challenges of Taking on the "Sponsor" Role in Investigator-Initiated Studies Understanding the additional obligations and resources required in relation to:

17. Thank you