Clinical Trials Process - C.Dee

Clinical Trial Process

Clinical Trials Office

Study Start-Up and Feasibility

• Sponsor contacts physician or site to gauge interest.
• Confidentiality Disclosure Agreement (CDA) signed by site.
• Feasibility assessment conducted:
• Can we do the study?
• Should we do the study?
• Clinical Research Implementation Committee (CRIC).

Pre-Site Visit

• Sponsor gauges site’s ability to conduct trial.
• Pharmacy tour
• CTPC tour
• Clinic tour
• Review processes and SOPs
• Address any additional questions from sponsor.

Approval Process

• Scientific Review Committee (SRC)
• Institutional Review Board (IRB)
• Budgets and Contract
• Office of Contracts Management (OCM)
• Radiology Core set-up
• Beacon build
• Site Initiation Visit (SIV)

Enrollment

• Patients recruited, consented, screened, and enrolled.
• Patient visits and data collection.
• Monitor visits conducted by Contract Research Organization (CRO).
• Review regulatory files.
• Verify data in EMR and Electronic Data Capture (EDC) system.
• Enrollment closed.
• No additional patients may be enrolled on study.

Study Close-Out

• Finalize data
• Remaining queries resolved and final visits entered
• Final payments received
• Study closed to IRB
• Records archived
• Off-site storage at Iron Mountain

Timeline

Timeline Cont.

References

National Institute on Aging. What are clinical trials and studies? (Obtained September 2022). https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies U.S Food & Drug Administration. (2020). Conducting clinical trials. (Obtained October 2022). https://www.fda.gov/drugs/development-approval-process-drugs/conducting-clinical-trials U.S. Food & Drug Administration. (2018). General principles for planning and design of multi-regional clinical trials. (Obtained September 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e17-general-principles-planning-and-design-multi-regional-clinical-trials