CTSU eCourse: Register with the CTSU

OBJECTIVE 1: REGISTRATION ELIGIBILITY

The Cancer Therapy Evaluation Program (CTEP) Account Management System (AMS) is a project of the National Cancer Institute designed to register and provide a unique identification number for all non-investigators (i.e., "Associates") participating in NCI-sponsored clinical trials through nine adult Cooperative Groups and to establish a user account for all Investigators (i.e., physicians) and Associates. All members of NCI-sponsored adult Cooperative Groups became eligible to obtain a user account through CTEP-AMS.

All Investigators and Associates participating in the research process through the CTSU are encouraged to establish a user account through CTEP-AMS. A CTEP-AMS user account is required to access the CTSU Members Web Site. In addition, CTEP-AMS allows each of the nine adult Cooperative Groups to claim registered associates to their respective Group rosters.

The electronic CTEP-AMS process initiates a single sign-on access that assigns a username and password to individuals participating in NCI-funded trials. The single sign-on access requires a unique email address for the current and/or new applicant.

Defining CTEP-AMS Applicant

Associates are defined as any individuals who are not physicians and who are affiliated with a recognized group operation or performance site who is considered to have some administrative or clinical role in the design, development, conduct, monitoring, or analysis of group-sponsored clinical trials.

Establishing a Cancer Therapy Evaulation Program-Acount Management System (CTEP-AMS) user account is available to Cooperative Group and CCOP members who are on a Group roster, particularly:

	Administrators	Pharmacists
	Study Coordinators	Physicians
	Data Managers	Research Assistants
	Nurses (LPN's and RN's)	Statisticians
	Certified Clinical Research Associates (CRAs)	Patient Advocates
In addition, membership is available to Patient advocates affiliated with a Cooperative Group or NCI initiative, CTSU staff, Cooperative Group Administrative Office staff and NCI staff. The CTSU has extended membership to investigators and staff who are not affiliated with a Cooperative Group. Before a non-affiliate Group physician can become a CTSU member through the CICRS program, he/she must meet standards similar to those for Cooperative Group members. Please see Objective 3 for additional information. Common questions regarding registration are:

Module Objectives
1	Summarize CTSU pre-registration information for Cooperative Group members
2	Initiate CTEP-AMS registration of Cooperative Group members
3	Explain the expansion of membership to investigators not Affiliated with a Cooperative Group (CTSU Independent Clinical Research Sites- CICRS)s
4	Identify the protocol-specific registration process and regulatory requirements that enable a site to participate in a clinical trial through the CTSU
5	Define the sequential steps in the patient registration process

WHAT ARE THE REQUIREMENTS FOR REGISTRATION?		Registration requires individual Group members to provide professional and contact information.
DO INVESTIGATORS NEED TO REGISTER WITH THE CTSU?		Yes-All investigators enrolling patients through the CTSU must register and be credentialed. Unlike the Cooperative Groups, in which membership is institution-based, the CTEP-AMS requires each investigator to register and be credentialed.
WHAT ARE THE REQUIREMENTS FOR INVESTIGATOR CREDENTIALING?		To be credentialed, an investigator must hold a Pharmaceutical Management Branch (PMB) assigned NCI investigator number, and have an active status in his/her associated Cooperative Group for treatment studies. To maintain active status in the PMB database, an investigator must submit the following documents annually to the PMB: FDA 1572 Form Curriculum Vitae Financial Disclosure Form Investigator Supplemental Data Form
HOW DOES AN INVESTIGATOR BECOME CREDENTIALED WITH THE CTSU?		The credentialing process is automatically initiated upon notification to the CTSU that the Investigator has received a CTEP-AMS user account. It is recommended that investigators register as CTSU members prior to submitting the protocol-specific site registration materials to the CTSU.

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