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Cancer Center

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

MCW Cancer Center Clinical Trials Office Adult Site Profile (PDF)

MCW IRB Policies and Procedures

SOP Glossary of Common Terms & Definitions (PDF) Updated 4/10/15 **Working Document**

Investigational Drug Service Policies and SOPs
  1. Investigational Drug Temperature Monitoring Temperature Exclusion Policy (PDF)
  2. Investigational Drug Record Retention SOP (PDF)
  3. Clinical Research, Investigational Drug Policy (PDF)
  4. Investigational Drug Disposition and Destruction Policy (PDF)
  5. Investigational Drug Accountability and Inventory Management (PDF)
  6. Monitoring Visit Policy (PDF)
  7. Priming and Administering Intravenous (IV) Investigational (INV) agents Guideline (PDF)
  8. Formulary Management of Biosimilars (PDF)
1. Administrative SOPs

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

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

2. Study Selection

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

2.4 Study Subject Randomization for Investigator Initiated Studies (PDF) February 11, 2022

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**