Roles and Responsibilities of Sponsor

 

ROLE AND RESPONSIBILITIES OF CLINICAL TRIAL PERSONNEL

(As per ICH-GCP)

DEFINITION: SPONSOR

Sponsor
A sponsor is an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial, as defined under International Council for Harmonisation-GCP, Food and Drug Administration regulations, and Indian GCP.

ROLES AND RESPONSIBILITIES OF THE SPONSOR

1. Selection of Investigator and Institution/Hospital

• Select qualified, trained, and experienced investigators.
• Ensure institutions/hospitals have adequate infrastructure, staff, and facilities.
• Provide:
• Approved protocol
• Investigator’s Brochure (IB) (current version)
• Confirm investigator’s ability to comply with protocol and GCP.

2. Contracts / Agreements

• Enter into written agreements with investigators and institutions.
• Agreements must clearly define:
• Trial conduct according to approved protocol and IEC approval
• Compliance with sponsor Standard Operating Procedures (SOPs)
• Sponsor’s right to monitor, audit, and inspect
• Financial arrangements and compensation
• Protocol must be signed by both sponsor and investigator as confirmation.

3. Allocation of Duties and Functions

• Identify, define, and allocate all trial-related duties.
• Ensure responsibilities are assigned to qualified personnel.
• Maintain documentation of delegation and oversight.
• Ultimate responsibility always remains with the sponsor, even if duties are delegated.

4. Clinical Trial Management, Data Collection, Handling & Record Keeping

• Continuously review trial progress, including:
• Safety data
• Efficacy endpoints
• Decide whether to continue, modify, or terminate the trial.
• When using electronic data systems, ensure:
• Written SOPs
• Audit trails
• Data security and restricted access
• Adequate backup and data recovery
• Maintain confidentiality of trial data.
• Retain essential sponsor documents as per regulatory timelines.

5. Compensation to Subjects and Investigators

• Ensure compensation for:
• Trial-related injury or death (subjects)
• Investigator payments as per agreement
• Payments must not influence trial conduct or subject safety.

6. Ethics Committee (IEC/IRB) Review Confirmation

• Ensure IEC/IRB approval before trial initiation.
• Obtain and maintain documentation of:
• Initial approval
• Continuing review
• Amendments and protocol deviations

7. Information on Investigational Product (IP)

• Provide sufficient non-clinical and clinical data on IP.
• Ensure information supports safe and proper use of the product.

8. Manufacturing, Packaging, Labeling & Coding of IP

• Ensure IP is manufactured according to GMP.
• Labeling must comply with regulatory requirements.
• Coding systems must allow blinding and emergency unblinding.

9. Supply and Handling of Investigational Product

• Ensure proper:
• Storage
• Distribution
• Accountability
• Maintain records of:
• Shipment
• Dispensing
• Return/destruction

10. Safety Information

• Continuously evaluate safety data.
• Ensure investigators are promptly informed of new safety findings.
• Update Investigator’s Brochure when required.

11. ADR / SAE Reporting

• Ensure timely reporting of:
• Serious Adverse Events (SAEs)
• Suspected Unexpected Serious Adverse Reactions (SUSARs)
• Comply with regulatory timelines and reporting formats.

12. Contract Research Organization (CRO) Management

• Sponsor may transfer duties to a CRO.
• Must:
• Clearly document delegated responsibilities
• Maintain oversight and accountability
• Legal responsibility cannot be transferred.

13. Record Access

• Allow regulatory authorities, IEC, and auditors direct access to trial-related records.
• Ensure subject confidentiality is maintained.

14. Monitoring

• Implement a monitoring plan.
• Ensure:
• Subject safety
• Data accuracy and completeness
• Protocol and GCP compliance

15. Audit

• Conduct independent audits when required.
• Ensure audit findings are documented and corrective actions implemented.

16. Premature Termination or Suspension

• May terminate/suspend trial for:
• Safety concerns
• Lack of efficacy
• Administrative or regulatory reasons
• Notify:
• Investigators
• IEC
• Regulatory authorities
• Provide written explanation.

17. Clinical Trial / Study Reports

• Prepare comprehensive clinical study reports.
• Reports must be accurate, complete, and verifiable.

18. Multicenter Trials

• Ensure:
• Standardized protocol implementation
• Consistent data collection across sites
• Coordinated monitoring and reporting