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

a. Investigational Drug Temperature Monitoring Temperature Exclusion Policy (PDF)

b. Investigational Drug Record Retention SOP (PDF)

c. Clinical Research, Investigational Drug Policy (PDF)

d. Investigational Drug Disposition and Destruction Policy (PDF)

e. Investigational Drug Accountability and Inventory Management (PDF)

f. Monitoring Visit Policy (PDF)

1. Administrative SOPs

1.1 SOP on SOPs v.4.0 (PDF) **June 26, 2018**

1.2. Process Change Management(PDF) **June 26, 2018**

2. Study Selection

2.3 Management of EAP and Treatment Use Protocols (PDF) **June 26, 2018**

3. Study Feasibility

No documents at this time.

4. Study Setup
4.1.1 Required Protocol Training v 4.0 (PDF) **November 19, 2019**

4.4 Protocol Implementation Meetings v.3.0 (PDF) **June 26, 2018**

5. Study Conduct

5.3. Patient Screening & Enrollment v.4.0 (PDF) **June 26, 2018**

5.7. 5.7. Study Subject Unblinding v.3.0 (PDF) **June 26, 2018**

6. Ongoing Processes

6.1. Study Monitors & Monitoring Visits v.5.0 (PDF) **June 26, 2018**

6.2.4. External Safety Reports – Industry Sponsored v.2.0 (PDF) **June 26, 2018**

6.2.5. External Safety Reports – Cooperative Groups v.2.0 (PDF) **June 26, 2018**

6.2.6.2.1. Completing the FDA 1572, Financial Disclosures and CVs v.5.0 (PDF) **June 17, 2019**

6.2.6.2.3 Documenting Delegation of Authority v.2.0 (PDF) **June 26, 2018**

6.2.6.3. Investigator Brochure Version Control v.3.0 (PDF) **June 26, 2018**

6.3.4. Consenting Study Subjects v.3.0 (PDF) **June 26, 2018**

6.4.2 Investigator Review of Subject Laboratory Reports v.2.0 (PDF) **Feb 28, 2019**

6.5.3. External Audits v.4.0 (PDF) **June 26, 2018**

6.5.4. Planned Study Transition Between CTO Employees v.2.0 (PDF) **June 26, 2018**

6.5.5. CTO Employee Resignation v.3.0 (PDF) **June 26, 2018**

6.5.6. Use of Care Everywhere in Epic for Clinical Trials v.2.0 (PDF)**June 26, 2018**