Decisions

Site Qualification Form

When a sponsor (or their representative, like a Clinical Research Organization [CRO]) approaches you about participating as a site in the trial, they usually send a form to evaluate whether you are set up to conduct the trial. This site qualification form asks about:

• Your board licensure
• Any currently competing studies
• Your access to the patient population
• Your research team’s availability (research coordinators, co-investigators)
• Ability to use central versus local Institutional Review Board
• Access to laboratories, pharmacy, freezer space, and so forth
• History of FDA inspections

Once the sponsor/CRO has confirmed your general qualification, they will send you a “Confidential Disclosure Agreement” or “Non-Disclosure Agreement” (see Confidentiality/Non-Disclosure Agreement tab below) for the UW Office of Sponsored Programs to review, negotiate, and sign. After that, the sponsor/CRO can send you a copy of the protocol and you can assess (see Feasibility tab below) whether the trial is viable for your site and a good fit for your research interests.

Confidentiality Disclosure/Non-Disclosure Agreement

A Confidential Disclosure Agreement, also called a Non-Disclosure Agreement, is a legal document for the protection of proprietary information. The sponsor will send this legal document to you before sharing any proprietary details about the trial. You must forward it to the University of Washington Office of Sponsored Programs for review, negotiation, and signature. Once the sponsor has received the signed document, the sponsor will provide you with the complete protocol, Investigator’s Brochure, Clinical Trials Agreement, and draft budget.

UW OFFICE OF SPONSORED PROGRAMS
(206) 543-4043 | osp@uw.edu

Feasibility

Before moving ahead with a new trial, assess whether it is truly feasible for you and your team to conduct the study. Some feasibility considerations are:

• Ready access to the eligible patient population
• Necessary facilities and services to conduct the trial
• Time and availability of qualified research team members
• Sufficient budget to cover all costs

It may also be helpful to consult with a biostatistician, biomedical informatics consultant, or clinical trials mentoring program to assess feasibility.

Department Approval

Your department may need to approve your participation as a site on an industry-sponsored clinical trial. Once you have received the Confidentiality Disclosure/Non-Disclosure Agreement, contact your department’s designee to find out the requirements to move forward. Your department designee might be a:

• Department director
• Department administrator
• Research chair
• Grants administrator/manager
• Fiscal specialist
• Research manager

Be sure to ask your department contact whether your department has any requirement for scientific review of clinical research, and whether there are departmental resources to further support setting up your study (e.g., budgeting/billing, Institutional Review Board).

Site Qualification Visit

Many industry sponsors/Clinical Research Organizations conduct site qualification visits to determine if the investigator and clinical site have the resources in place to conduct the trial. During this visit, the sponsor/Clinical Research Organization will discuss the basic fundamentals of the protocol with the investigator, research coordinator, and representatives from supporting departments, like pharmacy. Topics of discussion during the visit include:

• Investigator responsibilities
• Qualifications of investigator and research team members
• Study objectives, eligibility criteria, patient recruitment, and protocol-required procedures
• Institutional Review Board and informed consent requirements
• Adverse event reporting, source documentation, and record-keeping practices
• Space requirements, storage requirements for study products, and availability of required equipment

The sponsor/Clinical Research Organization will usually request a tour of the research facilities as part of the visit.

If you would like assistance in preparing for a site qualification visit, contact the ITHS Accelerator.