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 |
INVESTIGATOR CREDENTIALING
To be credentialed, an investigator must hold a Pharmaceutical Management Branch (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 investigator's active status in the PMB database, an investigator must have these documents on file with the PMB:
FDA 1572 Form: The FDA 1572 Form is completed and signed by the Investigator of Record (IoR). An IoR is defined as the physician responsible for ensuring that a clinical investigation is conducted according to the obligations stated in the signed FDA 1572 Form.
The NCI requires annual filing of the FDA 1572 Form as assurance to CTEP that all NCI-sponsored trials carried out under the investigator will be performed following ethically and scientifically sound principals.
A new FDA 1572 Form must be submitted to the PMB whenever a change in any of the required information, such as the name or address of the IoR or a change in the site IRB, occurs within the current year.
The FDA 1572 Form is located at this link: http://ctep.cancer.gov/forms/08-FDAForm1572.doc.
Curriculum Vitae (CV): A current CV with research-related activities is submitted by the IoR signing the FDA 1572 Form.
NCI requires annual filing of the physician CV.
CVs need not be resubmitted unless there is a significant change (e.g. change of title, address, affiliation).
Financial Disclosure: Effective February 2, 1999, the FDA requires any clinical investigator making a significant scientific contribution to a study to disclose financial relationships that may be affected by the outcome of a study. This requirement pertains to all studies of drugs, biological products, or devices that have a marketing application or reclassification petition that the applicant or FDA rely on to establish that the product is effective.
The NCI has created a Financial Disclosure Form to comply with the FDA ruling. This form will be collected from investigators annually and requires investigators to report any financial relationships that may pose a conflict of interest.
Investigator Supplemental Data Form: Beginning in March 2002, investigators must complete this form and submit it to the PMB annually with the other documents. The purpose of this form is to collect additional information on investigators that can be used by the NCI and Cooperative Group system.
A new Investigator Supplemental Data Form must be submitted to the PMB whenever a change in any of the required information, such as the name or address of the IoR or a change in the site IRB, occurs within the current year.
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If the investigator does not appear in either the PMB or Cooperative Group databases, the CTSU contacts the investigator and requests the appropriate information. If the investigator does not have an active status in the PMB database, the CTSU contacts the investigator. The appropriate documents must be submitted to the PMB before that investigator can enroll a patient.