Investigators enrolling patients through the CTSU must be credentialed by the CTSU. Unlike the Cooperative Groups, in which membership is institution based, the CTSU requires each Investigator to register. This process is automatically initiated upon notification to the CTSU that the Investigator has received a CTEP-AMS user account.

To be credentialed, an Investigator must hold an active PMB-assigned NCI Investigator number, and an active status with his or her associated Cooperative Group for treatment studies. Investigators who cannot obtain a CTEP-AMS user account may request CTSU membership through the Third Party Membership Request Form on the CTSU members' web site. This request may be initiated by a registered Associate on the institution's staff.

For the Investigator to maintain an active status in the PMB database, the following documents must be submitted annually to the PMB, These forms can be found on the CTSU Non-Group Investigator Page.

1. Investigator Form FDA 1572

2. Curriculum Vitae (CV)

3. Supplemental Investigator Data Form

4. Financial Disclosure

If the Investigator attempts to enroll a patient, however does not appear in either the Pharmaceutical Management Branch or Cooperative Group databases, the CTSU contacts the Investigator and requests the appropriate information. The appropriate documents must be submitted to the PMB and an investigator number assigned before that Investigator can proceed with enrolling a patient.

A new Form FDA 1572 and Supplemental Investigator 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. CVs must also be resubmitted if there is a significant change (e.g., change of title, address, and affiliation).

Registration with the CTEP-AMS is available only by completing an online application. New members (Investigators and/or noninvestigators) should access the CTEP-AMS online application at the CTEP-AMS web site to register to become a CTSU member. Current CTSU members (Investigators and/or noninvestigators) will be directed to the CTEP-AMS online application by entering the CTSU public web site.

Renewal registration into the CTEP-AMS system is required annually to maintain active membership. Electronic reminders will be sent to the active member 2 weeks prior to the membership expiration date. Users must update both their account information and their password information on a yearly basis. Account information can be updated by clicking the link provided in the reminder email or accessing the CTSU public web site "Register with the CTSU" tab or the link directly to the CTEP-AMS given below. Follow the instructions as outlined on the online form to update your user account information.

*** hint*** Reminder notifications are sent only for account updates. Therefore, it is a good idea to update your password and account information on the same schedule.

The CTSU has extended membership to institutions not affiliated with a Cooperative Group, otherwise known as CICRS. Investigators and Associates at institutions applying to the CTSU Independent Clinical Research Sites program must receive approval from CTSU prior to applying for a CTEP-AMS account.

3: Important: New Investigators must engage in the following application process through the Pharmaceutical Management Branch to secure an NCI identification number and initiate steps for active enrollment on a group roster. The following steps must be completed annually:

Forms filed with the PMB of NCI on an annual basis include the following:

- Current Form FDA 1572

- CV

- Supplemental Investigator Data Form

- Financial Disclosure Form

The CTSU Bimonthly Broadcast Summary will update registered members regarding recent CTSU protocol activations/closures, protocol-specific amendments, or memoranda issued by the Cooperative Groups, in addition to drug notices and safety reports, and general CTSU memoranda and notices. These summaries will be archived on the CTSU web site.

The CTSU will send out urgent broadcast messages on an as-needed basis. Bimonthly broadcasts will have a single link to the Registered Members Web Site. Since this is a protected site, the CTEP-AMS username and password will be required to access this area.

The function of the CTSU Help Desk is to assist members and answer questions in an efficient and effective manner. The CTSU Help Desk hours are from 9 AM - 5:30 PM Eastern Time, Monday - Friday (excluding holidays). The Help Desk can be reached at 1 (888) 823-5923 to respond to both general CTSU questions and protocol-specific questions. Voicemail is available if the Help Desk is reached during off hours, and messages will be responded to by the next business morning.

(Reminder: If you have eligibility or treatment questions about a CTSU study, you may contact the Study Chair or Group Operations Office directly. Contact information can be found within each protocol.)

The CTEP-AMS Registration Help Desk is also available to assist members and answer questions. The CTEP-AMS Help Desk hours are from 8:30 a.m. to 4:40 p.m. Eastern Time, Monday through Friday. Questions can be emailed to ctepreghelp@ctep.nci.nih.gov. (The CTEP-AMS Help Desk and the CTSU Help Desk are separate from one another.)