UNIT 8: Roles and Responsibilities in Clinical Research
This unit explains the roles, responsibilities, and interactions of key stakeholders involved in the conduct and oversight of clinical research. It focuses on how defined responsibilities ensure subject protection, regulatory compliance, and successful trial execution.
The sponsor is the individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical trial. Sponsors are accountable for ensuring that trials are designed, conducted, monitored, and reported in compliance with regulatory requirements and Good Clinical Practice (GCP).
| Responsibility Area | Sponsor Obligation |
|---|---|
| Trial Design and Protocol Development | Develop scientifically sound and ethically acceptable protocol, define objectives, endpoints, inclusion/exclusion criteria, and statistical analysis plan. |
| Regulatory Compliance | Submit protocol and supporting documents to regulatory authorities and ethics committees, obtain approvals, and maintain compliance throughout the trial. |
| Funding and Resource Allocation | Provide financial support for investigational product, site payments, monitoring, and data management. |
| Selection and Qualification of Investigators and Sites | Ensure investigators and sites are qualified, have adequate facilities, and trained staff. |
| Provision of Investigational Product | Manufacture, label, store, and supply investigational product per GMP; maintain accountability for drug distribution and return. |
| Monitoring and Oversight | Implement monitoring plan, conduct site visits, and ensure compliance with protocol, GCP, and regulatory requirements. |
| Safety Management | Collect, analyze, and report adverse events and serious adverse events to regulatory authorities and ethics committees within timelines. |
| Data Management and Statistical Analysis | Ensure accurate data collection, validation, and analysis; maintain confidentiality and integrity of trial data. |
| Compliance with GCP and Local Regulations | Adhere to ICH-GCP guidelines and applicable local laws throughout the trial lifecycle. |
| Final Study Report and Publication | Prepare and submit Clinical Study Report (CSR) to regulatory authorities; ensure transparency in reporting results. |
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