The CTRU is adept at helping clinical researchers understand and navigate WVU's clinical trials system. The three tracks that comprise the Health Sciences protocol, contract, and budget approval processes are:

• Institutional Review Board (IRB)
• Office of Sponsored Programs (OSP)
• Regulatory Documents

We assist researchers with each of these tracks. Below is information about what each track requires.

IRB track

This track includes the preparation, review, and approval of the protocol and key elements by the Institutional Review Board. The components and related documents are:

• "Institutional Review Board Protocol Statement" ( PDF and RTF ) -- describes the proposed protocol and administrative information.
• "Institutional Review Board Checklist for Submitting a New Protocol" ( PDF) -- helps the preparer complete the Protocol Statement form and the protocol itself.
• Consent/Assent Form describes the drug and the objective(s) of the trial, the protocol and patient requirements, the risks involved in participating in the trial, and the rights of the patients. This form should be written at a sixth grade reading level. "A Guide to Informed Consent." provides additional guidelines for correct preparation of the consent form.
• Study Abstract -- summarizes the study's purposes and procedures.
• Discussion -- provides complete and detailed information about the study, including risks, benefits, recruitment criteria, costs and/or payments to the subjects, alternatives, all investigative personnel, and right to confidentiality.

For additional information or assistance, you may consult the "Institutional Review Board for the Protection of Human Research Subjects Guidelines" This document provides more information on the regulations and procedures required for conducting research with human subjects. You may also contact the CTRU.

OSP track

This track encompasses the contractual and financial aspects of the proposed study. It includes:

• Budget Preparation and Approval (including the Facilities and Administration Rates).
• Completion of the "WVU and WVU Research Corporation Sponsored Programs Application Approval Sheet" (referred to as the "Blue Sheet") ( DOC).
• "Unrelated Business Income Tax Research Questionnaire" (UBIT) ( Excel ).
• Review and approval of sponsor-provided (external) contracts.

Regulatory Documents track

This track includes the preparation of regulatory documents required by external agencies; They include:

• "Statement of Investigator" (FDA 1572) (DOC) -- required by the FDA, this is a promise to conduct the trial in accordance with Good Clinical Practices ( PDF). The 1572 is completed by the primary investigator and filed by the sponsor. It includes the investigator's name, address, and curriculum vitae, and a list of all subinvestigators. By signing the form, the investigator agrees to comply with Federal regulation 21 CFR Part 312.
• Financial Disclosure Statement -- requires the investigator to certify that no financial arrangements have been made " ... where study outcome could affect compensation; that the investigator has no proprietary interest in the tested product; that the investigator does not have a significant equity interest in the sponsor of the covered study; and that the investigator has not received significant payments of other sorts; and/or disclosure of specified financial arrangements and any steps taken to minimize the potential for bias." Documentation is provided through submission of the "Certification: Financial Interests and Arrangements of Clinical Investigators" form (FDA 3454) ( DOC) and the "Disclosure: Financial Interests and Arrangements of Clinical Investigators" form (FDA 3455) ( DOC).
• Investigator Agreement.
• Investigator Curriculum Vitae.
• IRB Roster.
• Lab Normals.
• Lab Certification.

There are also Selected FDA regulations that guide clinical trials practices:

• 21 CFR 50, Protection of Human Subjects; Subpart A, General Provisions; Subpart B, Informed Consent of Human Subjects ( PDF)
• 21 CFR 54, Financial Disclosure by Clinical Investigators ( PDF)
• 21 CFR 56, Institutional Review Boards ( PDF)
• 21 CFR 312, Investigational New Drug Application ( PDF)

In addition to these required forms, The CTRU has designed some tools to help you with your protocol submissions. They are:

• "Guidelines for Investigator-Initiated Protocol Development" ( RTF) -- guides investigators through a protocol template.
• "Protocol Design and Development Checklist" ( PDF) -- provides investigators with a preliminary screening tool highlighting key elements for consideration when designing a protocol.
• "Protocol Submission Checklist" ( PDF) -- documents IRB elements, OSP elements, and regulatory documents that constitute a complete protocol submission. documents IRB elements, OSP elements, and regulatory documents that constitute a complete procotol submission.
• "Protocol Reviewer Checklist" ( PDF) -- provides protocol reviewers with a guide of what to look for when reviewing protocol submission.

Other documents pertaining to the protection of human subjects are:

• 45 CFR 46, Federal Policy for the Protection of Human Subjects, Department of Health and Human Services
• 59 CFR 59, NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Department of Health and Human Services
• Declaration of Helsinki, The World Medical Association
• The Belmont Report, U.S. Department of Health, Education, and Welfare
• The Nuremberg Code, "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182

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