CTSU eCourse: Register with the CTSU

INVESTIGATOR REQUIREMENTS

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Unlike the Cooperative Groups, in which membership is institution based, the CTEP-AMS requires that each Investigator be registered and credentialed. Credentialing requires that the Investigator have the following:

Required forms on file with the Pharmaceutical Management Branch (PMB) of NCI that are resubmitted on an annual basis:

FDA 1572 Form

Current Form FDA 1572 (original signature)- Form FDA 1572 is signed by the Investigator of Record (IoR) completing the form. 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.

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, whether or not investigational drugs are used, as assurance that all Investogators are liscensed and have appropriate experience.

Financial Disclosure

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

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. Investigators who belong to multiple Groups need to register only once annually, since this information is available to all the Groups to which they belong.

CTEP-AMS Membership

Required current active membership in an adult Cooperative Group or CTSU Independent Clinical Research Site affiliation.

NOTE: All Investigators treating patients on NCI-funded trials must register with the CTEP PMB regardless of whether they will or will not receive study drugs.

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INVESTIGNOTE: All Investigators treating patients on NCI-funded trials must register with the CTEP PMB regardless of whether they will or will not receive study drugs. ATOR REQUIREMEN