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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. 

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Adult Site Profile, IRB Procedures and Glossary of Common Terms and Definitions
1. Administrative SOPs

1.1 SOP on SOPs v.4.0 (PDF) **June 10, 2020**

1.2. Process Change Management(PDF) **June 10, 2020**

2. Study Selection

2.3 Management of EAP and Treatment Use Protocols (PDF) **June 10, 2020**

3. Study Feasibility

No documents at this time.

4. Study Setup
4.1.1 Required Protocol Training v 4.0 (PDF) **June 10, 2020**

 

4.4 Protocol Implementation Meetings v.3.0 (PDF) **June 10, 2020**

 

5. Study Conduct

5.3. Patient Screening & Enrollment v.4.0 (PDF) **June 10, 2020**

5.7. 5.7. Study Subject Unblinding v.3.0 (PDF) **June 10, 2020**

6. Ongoing Processes

6.1. Study Monitors & Monitoring Visits v.5.0 (PDF) **June 10, 2020**

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

6.2.4. External Safety Reports – Industry Sponsored v.2.0 (PDF) **June 10, 2020**

6.2.5. External Safety Reports – Cooperative Groups v.2.0 (PDF) **June 10, 2020**

6.2.7 CCCTO Laboratory Processes (PDF) **June 10, 2020**

6.2.6.2.1. Completing the FDA 1572, Financial Disclosures and CVs v.5.0 (PDF) **June 10, 2020**

6.2.6.2.3 Documenting Delegation of Authority v.2.0 (PDF) **June 10, 2020**

6.2.6.3. Investigator Brochure Version Control v.3.0 (PDF) **June 10, 2020**

6.3.4. Consenting Study Subjects v.3.0 (PDF) **June 10, 2020**

6.4.2 Investigator Review of Subject Laboratory Reports v.2.0 (PDF) **June 10, 2020**

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

6.5.3. External Audits v.4.0 (PDF) **June 10, 2020**

6.5.4. Planned Study Transition Between CTO Employees v.2.0 (PDF) **June 10, 2020**

6.5.5. CTO Employee Resignation v.3.0 (PDF) **June 10, 2020**

6.5.6. Use of Care Everywhere in Epic for Clinical Trials v.2.0 (PDF) **June 10, 2020**