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 OBJECTIVE 3: NON-GROUP MEMBER CREDENTIALING PROCESS

In May 2002, the CTSU opened accrual to its protocol menu of studies for all qualified medical, radiation, and surgical oncologists and hematologists who are not Cooperative Group members. The CTSU Independent Clinical Research Site (CICRS) program is opened to physicians throughout the United States who treat patients with cancer. Before they can enroll patients, institutions and physicians must meet qualifications similar to those for Cooperative Group members.

The following sections describe the qualification process and provide guidance for the preparatory activities of non-Cooperative Group members who express interest in joining the CTSU.

Beginning the Qualification Process
Assessing Investigator and Site Potential as a CICRS
CTSU Member Registration for CICRS
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)
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
Beginning the Qualification Process

An investigator who is interested in participating in the CICRS program, but who is not a member of a Cooperative Group, should complete an interest form. The interest form can be completed online or can be obtained by calling the CTSU Help Desk at 1-888-823-5923. The form can be completed electronically.

Electronic Inquiry
Step 1: To access the online interest form, log onto http://www.ctsu.org. Click on the "Non-Group Investigators" tab at the top of the CTSU Public Website page and then click on the link entitled interest form.
Step 2: Provide information regarding potential member's name, email address, mailing address, and answers to the questions about prior research experience, IRB affiliation, and research support staff. Required fields are identified with asterisks (*).
Step 3: When the form is complete, click the "submit" button at the bottom of the form.
Step 4: If the form is incomplete, a message will appear indicating that all required fields have not been completed. The form will not be electroically submitted to the CTSU until all the required fields are completed.

If difficulty is encountered accessing or completing the interest form, the researcher (physician, nurse, CRA, data manager, administrator, etc.) should contact CTSU by email at ctsucontact@westat.com or by calling 1 (888) 823 5923.

The CTSU will contact the physician by email after the interest form is received to provide more information on the CTSU and to determine if the physician wants to proceed with the application for CTSU membership.

 

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Assessing Investigator and Site Potential as a CTSU Independent Clinical Research Site

A physician who determines that he or she wants to pursue membership in the CICRS program should complete the CICRS Application Form and submit all required supporting documentation. (The physician may designate another person to complete the form.) The CTSU will provide assistance and guidance throughout this evaluation and qualification process. The CICRS Administrator may be contacted at any time during the review process for assistance.

Although prior research experience is not a requirement for CICRS membership, the CTSU must ensure that Investigators are qualified and have the appropriate staff and facilities to participate in clinical research. The CICRS application provides information on the Investigator's plans for implementing and conducting a study at the practice facility. The application asks questions about Investigator qualifications, research experience, patient population, demographics of the practice facility, support staff experience in the conduct of clinical trials, site performance in clinical trials, and site infrastructure, such as computer support. In response to these questions, the Investigator will do the following:

  • Provide answers to all questions, attaching additional pages as necessary
  • Complete the additional forms that were included with the CICRS Application
    • Form FDA 1572
    • Supplemental Investigator Data Form
    • Financial Disclosure Form
    • Radiation Therapy Facilities Inventory Form
  • Attach the following documents:
    • Curriculum Vitae (CV)
    • Certification of Completion of Human Subjects Protection Training
    • Laboratory Certification
    • Quality Control / Quality Assurance Plan (if applicable)
  • Mail all forms and documents to the CICRS Administrator: Westat 1441 West Montgomery Avenue, Rockville, MD 20850-2062 Attn: Khalil Ayubi WB 341

After receipt of the CICRS application and all supporting documentation, the CICRS Administrator will contact the site to schedule a Pre-Review evaluation call. The purpose of this call is to access the site qualifications for participating on National Cancer Institute funded adult Cooperative Group trials through the CTSU. Questions regarding regulatory compliance, facilities, staffing, prior experience with clinical trials, and the institution's standard operating procedures are covered. The call also allows the site to ask CTSU staff questions on the CTSU procedures.

Prior to the Pre-Review call, the site will receive from the CTSU Education and Promotion staff a binder of NCI/CTSU resources. An opportunity to ask questions regarding the information in the binder will be provided during the Pre-Review call.

A review panel consisting of NCI and CTSU staff then evaluates the CICRS application and the Pre-Review call report. The following recommendations may be made by the panel:

  • Approval/ pending outside review - the applying site meets all qualifications to participate in the CICRS program. Review of the application materials and Pre-Review report is completed on all applicant sites and found acceptable. A contract is sent to the site at this time for review and consideration. Final approval is not granted until outside review is complete. The timeframe for outside review is 10 -14 days.
  • Approval/pending site visit - the applying site meets the qualifications to participate in the CICRS program, but additional evaluation and training of the institution is needed because of limited clinical trials experience. Sites in this category are reviewed by the panel after completion of the site visit. Some training may also be provided at the discretion of the person evaluating the site as time permits.
  • Pending additional information - items on the application or on the Pre-Review call report have raised concerns that must be addressed prior to further consideration of the panel. For example, documentation may be required from a Cooperative Group or in regard to a site's FWA.
  • Disapproval - the applying site's application and/or prereview call report have uncovered issues that make the site ineligible for approval for the CICRS program at this time. Examples of such items include inadequate IRB coverage, limited patient population, inadequate facilities, or prior poor performance on previous Cooperative Group trials. A CICRS mentor is available to discuss possible remedies to discuss the sites challenges, at the site's request.
The CICRS administrator will contact the physician to discuss the outcome of the evaluation. Once the site has been approved pending outside review, the CICRS mentor will start interacting with the site. This will include reviewing the CTSU binder information as well as assessing the site's educational needs. Once the contract has been signed and the site is deemed eligible to begin enrolling patients, the CICRS mentor will assist the site in obtaining CTEP-AMS accounts, facilitating the IRB approval process and protocol registration process.

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CTSU Member Registration for CICRS

After the determination is made that the site may participate in the CICRS program and the signed contract has been received by the CTSU, the Investigators and the Associate staff are directed to obtain user accounts from the CTEP-AMS to establish CTSU membership and access the CTSU Registered Member Web Site. The members' web site provides all necessary documents and forms to participate in a clinical trial through the CTSU. Other staff at the site, such as the research nurse and data manager, are encouraged to register to receive their own username and password.

Important Notes for CICRS:

  • A contract between the site and CTSU must be signed before CICRS sites can enroll patients onto trials through the CTSU. The CICRS members are reimbursed according to the same policies and procedures as Cooperative Group members.
  • The CICRS members follow the same policies and procedures (e.g., protocol-specific site registration, patient enrollment, AE reporting, auditing) as the Cooperative Group members.
  • After a CICRS site has been approved to participate with the CTSU, the CTSU submits the Form FDA 1572, CV, Financial Disclosure Form, and Supplemental Investigator Data Form to the Pharmaceutical Management Branch of the National Cancer Institute. These documents enable the PMB to assign the Investigator an NCI Investigator Number. The Investigator must annually submit these forms to the PMB to maintain an active status in the PMB database. This is a requirement for all Investigators desirig to participate in NCI-funded research regardless of Cooperative Group or CICRS membership.
  • CICRS sites are required to accrue five patients per year onto studies through the CTSU.

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