GettyImages-932533514-hero

Clinical Research SOPs

Includes SOPs for clinical trials office staff and other important documents including the Adult Site Profile and a glossary of common terms and definitions. 
all
Adult Site Profile, IRB Procedures and Glossary of Common Terms and Definitions
1. Administrative SOPs

1.1 SOP on SOPs (PDF) **November 5, 2021**

1.2. Process Change Management (PDF) **February 11, 2022**

2. Study Selection
3. Study Feasibility

No documents at this time.

4. Study Setup

4.1.1 Required Protocol Training (PDF) - **June 19, 2019**

4.4 Protocol Implementation Meetings (PDF) **March 16, 2020**

5. Study Conduct

5.3. Patient Screening & Enrollment (PDF) **November 5, 2021**

5.7. Study Subject Unblinding (PDF) **March 16, 2020**

6. Ongoing Processes

6.1. Study Monitors & Monitoring Visits (PDF) **November 5, 2021**

6.2.1 COVID-19 Visitor Screening (PDF) **June 10, 2020**

6.2.4. External Safety Reports – Industry Sponsored (PDF) **November 5, 2021**

6.2.5. External Safety Reports – Cooperative Groups (PDF) **November 5, 2021**

6.2.6.2.1. Completing the FDA 1572, Financial Disclosures and CVs (PDF) **February 11, 2022**

6.2.6.2.3 Documenting Delegation of Authority (PDF) **September 2, 2021**

6.2.6.3. Investigator Brochure Version Control (PDF) **November 5, 2021**

6.2.7 CCCTO Laboratory Processes (PDF) **March 16, 2020**

6.3.4. Consenting Study Subjects (PDF) **November 5, 2021**

6.4.2 Investigator Review of Subject Laboratory Reports (PDF) **November 5, 2021**

6.5.2 Internal Quality Assurance Reviews (PDF) **June 10, 2020**

6.5.3. External Audits (PDF) **November 5, 2021**

6.5.4. Planned Study Transition Between CTO Employees (PDF) **February 20, 2018**

6.5.5. CTO Employee Resignation (PDF) **March 16, 2020**

6.5.6. Use of Care Everywhere in Epic for Clinical Trials (PDF) **June 10, 2020**