The CRU has designed some tools to help you with your protocol submissions. They are:
- WVU Cancer Institute Clinical Trials Operations Manual (The Blue Book) --policies and procedures to conduct clinical trials at West Virginia University Cancer Institute.
- Guidelines for Investigator-Initiated Protocol Development -- guides investigators through a protocol template.
- Protocol Design and Development Checklist -- provides investigators with a preliminary screening tool highlighting key elements for consideration when designing a protocol.
- Protocol Review and Monitoring Committee (PRMC) Submission Forms -- complete and submit to the CRU for protocol to be placed on the PRMC agenda.
The CRU 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. For more information contact Anne Schnatterly, BSN, RN, CCRP, Interim Director of CRU at 304-293-2745.
This track includes the preparation, review, and approval of the protocol and key elements by the Institutional Review Board. Visit the Office of Research Integrity and Compliance at WVU.
This track encompasses the contractual and financial aspects of the proposed study. It includes:
- Budget Preparation and Approval
- Completion of the WVU and WVU Research Corporation Sponsored Programs Application Approval Sheet
- Unrelated Business Income Tax Research Questionnaire
- Review of sponsor-provided contracts.
Regulatory Documents track
This track includes the preparation of regulatory documents required by external agencies; They include:
- Statement of Investigator (FDA 1572) -- required by the FDA, this is a promise to conduct the trial in accordance with Good Clinical Practices. 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) and the Disclosure: Financial Interests and Arrangements of Clinical Investigators form (FDA 3455).
- 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
- 21 CFR 54, Financial Disclosure by Clinical Investigators
- 21 CFR 56, Institutional Review Boards
- 21 CFR 312, Investigational New Drug Application
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