Medical College of Wisconsin
Medical College of Wisconsin Medical College of Wisconsin

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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)
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**