Steps to begin a Clinical Research Study at UW

Please note: The sequence of the steps may vary depending upon funding source.

• Step 1:  Confidential Disclosure Agreement Requirements

• Step 2a:  Regulatory Requirements for Studies utilizing the Office of Clinical Trials
  OR
  Step 2b: Regulatory Requirements for Studies not utilizing the Office of Clinical Trials

• Step 3:  Research Budgeting and Billing

Step 2a. 
Regulatory and Other Requirements:  For investigators Using Office of Clinical Trials Services

Upon receipt of the protocol and supporting documents from the sponsor:

Complete the “OCT New Study Information Form”. Bring this and all sponsor-provided documents, including protocol, drug brochure, electronic documents, correspondence, to H6/122. OCT services include:

1. Confidential Disclosure Agreement negotiating orrouting (if not already done)

2. Regulatory document preparation (FDA Form 1572, Financial Disclosure Form(s))
   (FDA form 1572 Word version | FDA form 1572 PDF version)

3. HS-IRB and other research committee submissions (e.g., VA R&D Committee, Cardiovascular Clinical Research Committee, Meriter Hospital IRB, UW CTRC (The Clinical and Translational Research Core). It is the investigator’s responsibility to complete the UW required human subjects and HIPAA training.

4. Preparation and negotiation of the study budget including the Pharmaceutical Research Center (PRC) budget. (The investigator is expected to coordinate directly with PRC for investigational product accountability, maintenance and handling.)

5. Study contract/clinical trial agreement routing

OR

Step 2b.  Regulatory and Other Requirements:  For Investigators NOT Using Office of Clinical Trials Services

If you do not use OCT services, the following are usual requirements for most industry sponsored investigational drug studies. Device study requirements are slightly different.

Most sponsors will provide a letter/checklist outlining the regulatory documents that need to be prepared and submitted to the sponsor. For the typical investigational drug study, these documents include:

1. FDA form 1572 (accompanied by the investigators’ current CV and a copy of state professional license)
   (FDA form 1572 PDF version | FDA form 1572 Word version)

2. Financial Disclosure form: sponsor-provided form that allows investigators to declare whether they have a financial interest in the sponsors company.

3. “IRB assurance letter” that includes the UW HS-IRB’s Federal Wide Assurance (FWA) number. IRB Roster: The UW HS-IRB does not have a roster of IRB members.
   
4. Protocol signature page: The signed signature page should be sent to the sponsor only after the contract language has been negotiated and approved by RSP.
   
5. If the study involves local laboratory tests, provide the UWHC Laboratory’s College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) certificates.
   
6. Submit a copy of the study protocol and drug brochure to the UW Pharmaceutical Research Center F6/133 and (request a budget).
   
7. IRB Requirements and Approval:

• IRB Submission forms and deadlines 

• The UW HS-IRB requires that all staff involved with clinical research complete the on-line Human Subjects Protection Training before the IRB will approve the research. Training should be completed prior to IRB submission.

• HIPAA requirements: All consent forms submitted must also have a corresponding HIPAA authorization. Please see the HIPAA Privacy Rules for Research web site for further information and templates

• More information can be found on the HS-IRB’s web site

• University of Wisconsin HS-IRB fee policy

8. Contract/Clinical Trial Agreement: The sponsor provides a contract, which is considered by the UW to be an agreement between the sponsor and the institution. The contract must be reviewed and approved by RSP. It is recommended this document be sent to RSP early on in the research approval process.  RSP will negotiate the contract language directly with the sponsor and will usually receive the final, approved contract from the sponsor and forward it to the investigator. Investigators must sign their contracts and therefore should be familiar with the contract terms.
   
9. After yhe budget and contract language have been negotiated, the final contract (including the agreed-upon budget) must be routed for signatures. Contract routing procedures can be found on the RSP website. If a form 88-1 ("Account in Advance of Award") is included in the routing procedure, RSP will automatically set up a fund account.

Step 1 | Step 2 | Step 3