UNIT 7: Clinical Trial Operations and Conduct
This unit explains how clinical trials are operationally executed from study start-up through close-out, focusing on site-level and sponsor-level activities that ensure protocol-compliant conduct. It reflects real-world trial execution, emphasizing feasibility, recruitment, investigational product handling, and operational oversight.
Study start-up activities include all preparatory steps required before enrolling the first subject. These activities ensure that the protocol, regulatory approvals, contracts, supplies, and training are in place so the trial can begin smoothly and compliantly.
| Activity | Purpose |
|---|---|
| Protocol finalization | Defines scientific and operational plan |
| Regulatory and ethics submissions | Obtain legal and ethical approval |
| Site contracts and budgets | Enable site participation |
| Site initiation | Prepare site for trial conduct |
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