Clinical Trials Office SOPs and Other Documents

1.    Administrative SOPs

1.1.   SOP on SOPs v.3.0 (PDF) **May 25, 2017**

1.2.   Change Management SOP (PDF) **May 25, 2017**

1.3.   Organizational SOP

1.4.   Education/Training

1.5.   Notifications

2.     Study Selection

2.1.   Identify Protocols

 2.1.1.     CDA

 2.1.2.     Feasibility

2.2.  Select Protocols

 2.2.1.     Research Manager Review

 2.2.2.     Faculty Disease Committee Review

 2.2.3.     Scientific Review Committee

   2.3 Management of EAP and Treatment Use Protocols (PDF) **May 25, 2017**

3.     Study Feasibility

3.1.  Develop/Process Contracts

3.2.  Budget/Logistics Development 

 3.2.1.     Study calendar creation

 3.2.2.     Standard of care/research determinations

 3.2.3.     Pricing

3.3.  Ancillary Committees

3.4.  Gather/Develop Site Documentation

4.     Study Setup

4.1.   Logistic Finalization

4.1.1.       Required protocol training v.3.0 (PDF) **May 25, 2017**

4.1.2.      Site initiation visits

4.1.3.      Clinicaltrials.gov submission/updating

4.1.4.      IND Application

4.2.  IRB Submissions

4.2.1.     New submissions

4.2.2.     Emergency Use Protocols

4.2.3.     Compassionate Use Protocols

4.3.  Accounting

4.4   Protocol Implementation Meetings v.3.0 (PDF)  **May 25, 2017**

5.     Study Conduct

5.1.   Notification of Study Opening to Enrollment

5.2.   Pre-screening

5.3.   Patient Screening & Enrollment v.4.0 (PDF)  **May 25, 2017**

5.4.   Schedule Services

5.5.   Research Billing Management

5.7.  Study Subject Unblinding v.2.0 (PDF) **May 25, 2017**

6.     Ongoing Processes

6.1.  Study Monitors & Monitoring Visits v.4.0 (PDF) **May 25, 2017**

6.2.  Regulatory

6.2.1.   Amendments

6.2.2.   CPRs

6.2.3.   Reportable Events

6.2.4.   External Safety Reports – Industry Sponsored v.2.0 (PDF) **May 25, 2017**

6.2.5.   External Safety Reports – Cooperative Groups v.2.0 (PDF) **May 25, 2017**

6.2.6.   General

6.2.6.1.   Uploading study documents in Oncore

6.2.6.2.   Regulatory document preparation & retention

6.2.6.2.1.  Completing the 1572 & Financial Disclosures v.3.0 (PDF) **May 25, 2017**

         6.2.6.2.2.  Completing the Delegation of Authority Log v.2.0 **Retired**

         6.2.6.2.3   Documenting Delegation of Authority v.1.0 (PDF) **July 17, 2017**

         6.2.6.3.  Investigator Brochure Version Control v.2.0 (PDF) **May 25, 2017**

         6.3. Clinical Research Coordinators

         6.3.1.     Randomizing a patient

         6.3.2.     Recording patient visits

         6.3.3.     Locating Current IRB Approved Protocol Documents

         6.3.4.     Consenting Study Subjects v.2.0 (PDF) **May 25, 2017**

         6.3.5.     Data Entry/CRF Completion

6.4.  Principal Investigators

6.4.1.      Financial disclosures, etc. timelines

6.4.2       Investigator Review of Subject Laboratory Reports (PDF) **July 28, 2017**

6.5. General

6.5.1.     Audit Preparation

6.5.2.     Internal Audits

6.5.3.     External Audits v.3.0 (PDF) **May 25, 2017**

6.5.4.     Planned Study Transition Between CTO Employees v.1.0 (PDF) **May 25, 2017**

6.5.5.     CTO Employee Resignation v.2.0 (PDF) **May 25, 2017**

6.5.6.    Use of Care Everywhere in Epic for Clinical Trials v.1.0 (PDF)**May 25, 2017**

7.     Study Closure

 7.1.   Closing a study to enrollment

          7.2.   Notification of Study Closure to Accrual

Investigational Drug Service Policies and SOPs 

a. Temperature Monitoring 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)

Clinical Trials Office

Search Active Clinical Trials

Adult Cancer Clinical Trials
Medical College of Wisconsin
Cancer Center Clinical Trials Office (CTO)

9200 W. Wisconsin Ave.
Milwaukee, WI 53226

(414) 805-8900 | Fax: (414) 805-0596
cccto@mcw.edu

Pediatric Cancer Clinical Trials
Jennifer Brown
Clinical Research Manager
Pediatric Hematology, Oncology & Transplant
Medial College of Wisconsin
MACC Fund Center for Cancer & Blood Disorders

(414) 266-8914 | Fax: (414) 955-0116
jlbrown@mcw.edu

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