Forms Only
          Laboratory Information and Certificates
             Other forms

The steps of a research study:

        As part of Study approval

• Step 1: Confidentiality agreement with sponsor

• Step 2: IRB Application and Approval
• Step 3: Pricing and Budget Development (may be done concurrently with Step 2)

• Step 4: Contract negotiation and approval (may be done concurrently with Step 2)

        After IRB approval

• Step 5: Account setup (may be done concurrently with Steps 1 & 2 if confident of IRB approval)

• Step 6: Recruit volunteers & Medical Record setup (only after IRB approval)

• Step 7: Ongoing requirements

• Step 8: Close Out Study
  

Step 1: Confidentiality Agreement with Sponsor
In most studies funded by a pharmaceutical or device company, the sponsoring company wants assurance that its proprietary information will not be divulged.  Therefore, they often require a Confidentiality Agreement prior to planning a clinical trial.  This document is not the same thing as a Clinical Trial Agreement (CTA) and does not need to be signed by Fairview.  

Step 2: IRB Application and Approval
All research involving human subjects (including records and specimens) conducted within Fairview Health Services requires Institutional Review Board (IRB) approval.   Applications must be signed by the director of Research Administration who then submits the application to the IRB.
The IRB application process is specific and detailed.  Links to information and a check list are available.

IRB Application Information
IRB Application Checklist (Word document)

Step 3: Pricing and Budget Development
The prices for laboratory, investigational drug services, ancillary services, and Fairview staff time need to be established in order to be included in research budgets.  Fairview Research Administration will assist with this process and will help to develop the research pricing budget in order to assure that all costs are covered.  This work can be done concurrently with the IRB application process.

• Budget Information - Link to Rates 
• Establish prices - Link to E-Form

Step 4: Contract negotiation and Approval
A Clinical Trial Agreement (CTA) is a 3-way agreement between the Investigator, Fairview Health Services, and the sponsor.  This contract typically specifies budget and payment schedule as well as publishing rights and requirements for the Investigator.  Send CTA to Fairview Research Administration when it is ready for authorized signature.  email: Research Administration

Step 5: Account Setup
An  E-Form  process has been developed to assist with pricing and the creation of required accounts.

Step 6: Recruit, Register, and Schedule Volunteers

• Register and Schedule Research Volunteers (instructions available)
• Use study specific encounter form at the time that services are rendered

Step 7: Ongoing Requirements

• Adverse Events Reporting
• IRB Continuing Review
• Changes in study personnel
• Conflict of Interest update annually, or any time there is a change
• 3-year education requirement update
• Amendments or changes to protocol
• Amendments or changes to  investigational drug brochure

Step 8: Close Out Study

• Close out Research Institutional Account
• Close out Foundation Account
• Final Report to IRB
• Sponsor specific reporting
• Plan for document storage
• Consider sending study results to Research Administration for inclusion in Fairview publications