Forms: Regulatory

CTEP Investigator Registration Guidelines
Food and Drug Administration (FDA) regulations and NCI policy require all investigators participating in any NCI-sponsored clinical trial to register and to renew their registration annually.
FDA 1572: Statement of Investigator Form (Pre-filled)
The primarly use is to identify qualified investigators and as experts to particpate in clinical investigations at the NCI.
CTEP IDF: Supplemental Investigator Data Form (Pre-filled)
Collection of this information serves two purposes. The first is to identify qualified investigators and associates to participate in the clinical investigations at NCI. The second purpose is to ensure that investigational agents are under the control a
CTEP FDF: Financial Disclosure Form
The use of this information is to disclose or certify information concerning the financial interests of the clinical investigators associated with clinical studies.
MIAP - MICHR IND/IDE Investigator Assistance Program
The MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research.excellence and regulatory compliance
CTEP AdEERS Form (Single Agent)
Single Agent AdEERS v4.0 Template Form
CTEP AdEERS Form (Multiple Agent)
CTEP AdEERS Form (Multiple Agent)
CTEP AdEERS (web submission)
NCI's web-based system for submitting expedited reports for serious and/or unexpected events forwarded to designated recipients and the NCI for all trials using a NCI-sponsored investigational agent.
FDA MedWatch 3500A Form
For mandatory reporting use by user-facilities, distributors and manufacturers.

Forms: Clinical

UMHS Patient Information Release Form
Patient authorization to research PHI to the recipient.
Anatomic Pathology Request for slide/block processing
Required for archive block /slide recuts or new tissue collections to be made into block. Refer to workaid: Tissue Specimen Acquisition (Archival Tumor Tissue)
Pathology: Charge Form
Pathology charge form for the preparation of slides for corporate clinical trials.
UMCCC Notification of Cancer Patient Death
This form should be initiated by the person who receives notification of a patient death and faxed to the appropriate clinic coordinator and bereavement office for completion.

Forms: Study

Transfer of Study Participant Between Investigational Sites
This form should be completed when transferring a UM study participant to another institutional site; or when a study participant from another site is transferring to a UM investigator.
Clinical Research Team (CRT) - Protocol Peer Review Form
This form should be completed by chair assigned reviewers when CRTs are reviewing protocols prior to PRC submission.
Clinical Research Team (CRT) - CTSU Feasibility Review Form
This form should be completed by CTSU personnel when CRTs are reviewing protocols prior to PRC submission.

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