Register
OBJECTIVE 4: PROTOCOL-SPECIFIC SITE REGISTRATION
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Module Objectives |
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1
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Summarize CTSU pre-registration information for Cooperative Group members |
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2
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Initiate CTSU registration of Cooperative Group members |
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3
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Explain the qualification process whereby investigators not affiliated with a Cooperative Group can be credentialed as CTSU members |
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4
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Identify the protocol-specific registration process and regulatory requirements that enable a site to participate in a clinical trial through the CTSU |
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5
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Define the sequential steps in the patient registration process |
OTHER IRB ISSUES
The PMB investigator's database has been expanded to include surgeons, radiation oncologists, and pathologists. Therefore, all investigators listed on the CTSU IRB Protocol Certification Form (including surgeons, radiation oncologists, and pathologists) must be credentialed by the CTSU. This means that an investigator must hold a PMB-assigned NCI investigator number, have an active status both in his/her Cooperative Group database and in the PMB database, and be registered with the CTSU. To maintain an active status in the PMB database, an investigator must have a current FDA 1572 Form, Curriculum Vitae, and Financial Disclosure Form on file with the PMB. Beginning in March 2002, an Investigator Supplemental Data Form must also be on file with PMB to maintain the investigator's active status.
It is incumbent upon the Principal Investigator to ensure that all treatment locations have IRB approval. All treatment locations must be listed on the CTSU IRB Certification Form or in the IRB Approval Letter. When the IRB is not located at the site, or the IRB address deviates substantially from the treatment facility, the CTSU will ask a designated contact person at the site to verify that the appropriate agreements exist between the local IRB and the institution.