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OBJECTIVE 4: RSS PROCEDURES, REQUIRED DOCUMENTATION, AND SUBMISSION

All adult Cooperative Group regulatory submissions (excluding STAR, SELECT, BCPT, PCPT, P-3, GOG 0190, MC9944, SWOG S9808, and SWOG S0316) must be mailed to the Cancer Trials Support Unit (CTSU) Central Regulatory Office located in Philadelphia.

The CTSU and the Adult Cooperative Groups have developed a central repository for Cooperative Groups' regulatory documents. The submission of data to the CTSU Central Regulatory Office will streamline the process for all Adult Cooperative Group members who currently provide regulatory documentation to several addresses, depending on their group affiliations.

Regulatory submissions are processed by CTSU staff and entered into a central database called RSS (Regulatory Support System). This database is accessible in near "real time" to the Cooperative Group administrative personnel. Regulatory submissions are processed within 3 business days after receipt at the CTSU Central Regulatory Office. Sites should allow adequate time between IRB approval and submission of regulatory forms to CTSU before enrolling patients. Immediate processing of regulatory forms can be accommodated when patient enrollment is scheduled to occur within the next 24 hours. Sites requesting "time of need" registration must contact the CTSU Help Desk upon faxing of the regulatory materials so that processing can be expedited.

This module provides new submission instructions for all adult Cooperative Group regulatory documents. The module objectives will guide the learner through this regulatory document procedure supported by the Regulatory Support System (RSS) database.
Objectives
1
 Identify the goals, benefits, and organization of the CTSU project
2
 Explain the major features of the CTSU financial system
3
 State the treatment credit assignment process for the Community Clinical Oncology Program
4
 Identify Regulatory Support System (RSS) procedures, required documentation, and a new submission procedure.
5
 Explain the availability of several web-based educational and promotional tools


Purpose of the RSS

The RSS database was designed in conjunction with the Coalition of National Cancer Cooperative Groups (CNCCG), Cancer Trials Support Unit (CTSU), and the adult Cooperative Groups. The collective goal was to centralize the various methods of regulatory document submission procedures conducted within these Groups.

The idea to create a centralized data repository was the origin of the Regulatory Support System (RSS) design. Thus, RSS Westat and Oracle Inc. initiative would process regulatory document submissions into a centralized database.

The plan would have all Group sites participating in the NCI-sponsored adult Cooperative Group clinical trials submit all regulatory documents to a central location. Hence, the new central location is the CTSU Central Regulatory Office document storage facility at the Coalition of National Cancer Cooperative Groups in Philadelphia, Pennsylvania.

Section topics include:

Regulatory Documents Required for Submission to the CTSU
IRB Certification Form with Required Documentation
Mailing Address
Helpful Tools

Regulatory Documents Required for Submission to the CTSU


Regulatory materials to be submitted to the CTSU Central Regulatory Office include the following:
Initial IRB protocol approvals (It is strongly recommended that the IRB certification form documenting IRB approval accompany these documents.)
IRB-approved consent forms if required by the sponsoring Cooperative Group
Continuing review approvals for protocols open to accrual or when indicated by the lead protocol Group for closed protocols

Approvals of amendments and revisions when required by the lead protocol Group

Protocol-specific requirements as instructed in the protocol document
IRB Approval Transmittal Form- required for the submission of Phase 1-3 regulatory documents

Click here to learn about protocol-specific site registration (Objective 4)

IRB Certification Form with Required Documentation

The CTSU Central Regulatory Regulatory Office strongly recommends that sites use the CTSU IRB Certification Form as documentation of IRB approval. (The IRB certification will be utilized as the standard data entry form to document IRB approvals in RSS.) The office will accept site-specific IRB approval letters only if they contain the following required elements:

All sites approved by the IRB to implement the protocol
Office for Human Research Protections assurance number for each approved institution
Lead Group protocol number and protocol title (may use short version)
NCI version date of protocol (required for amendments only)
Name of institution/CTEP site ID number
Name of Principal Investigator and CTEP Investigator ID number
Type of review (original, renewal or amendment)
Type of approval (full board, expedited or facilitated)
Date of review and expiration date if <364 days
IRB number if institutions use a FWA
Signature of IRB official


Omission of any of these data points will delay the verification of site IRB approval. Subsequently, the IRB approval cannot be entered in the RSS database and the enrollment of patients may be delayed.

A Guidance Document giving step-by-step instructions on the completion of the CTSU Transmittal form and CTSU IRB Certification form is available on the CTSU public web site under the RSS tab.

The IRB certification forms are available on the CTSU web site: www.ctsu.org.

Click here to learn more about protocol specific site registration and requirements.
(Objective 4: this information can be found in the learning module)

Mailing Address

The CTSU Central Regulatory Office is functioning as the central processing facility for the NCI-funded adult Cooperative Groups. The regulatory office is located at the Coalition of National Cancer Cooperative Groups in Philadelphia, Pennsylvania at the following address:

CTSU Central Regulatory Office
Coalition of National Cancer Cooperative Groups
1818 Market Street, Suite 1100
Philadelphia, Pennsylvania 19103

Fax Number: (215) 569-0206

Site regulatory documents for all adult Cooperative Group Phase I, II, and III prevention and treatment trials (excluding STAR, SELECT, BCPT, PCPT, P-3, GOG 0190, MC9944, SWOG S9808, and SWOG S0316) will be stored at the CTSU Central Regulatory Office, not only those on the CTSU menu. Mailing labels are available on the CTSU public web site (www.ctsu.org).


Helpful Tools
There are several tools available for participating members to facilitate a successful outcome of the new CTSU Central Regulatory Database. Click the links below to view and download these resources.
  • CTSU Help Desk: The function of the Help Desk is to assist members and to 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 for specific general CTSU and protocol-specific questions at 1 (888) 823-5923.
  • Notifications: All sites may access the CTSU Registered Members Web Site to check the status of their registrations at this link: www.ctsu.org. Click on the members' Resources tab and select the "RSS Site Registration Status." You will need your CTEP-AMS username and password, along with your CTEP institution code, in order to access the site
  • CTSU Online Operations Manual Chapter 24 - Regulatory Support System
  • RSS Quick Reference Facts
  • CTSU Central Regulatory Office at the Coalition of National Cancer
    Cooperative Groups Fax Number: 1-215-569-0206