Overview:
Cancer Trials Support Unit
(CTSU)
Presentation Outline
Introduction to the CTSU
Protocols on the CTSU menu
Participation in the CTSU
Accessing Protocols and Documents
Regulatory Support Services
Enrolling Patients on CTSU
Protocols
Reimbursement for Participation
Submitting Data for CTSU menu
trials
Auditing of CTSU Sites
Education and Promotion
Obtaining Help
Introduction to the CTSU
What is the CTSU?
A
service of the National Cancer Institute (NCI) that provides clinicians across
the United States and Canada access to cancer treatment trials.
A
project funded and directed by the NCI Cancer Therapy Evaluation Program (CTEP)
and operated by Westat and the Coalition of Cancer Cooperative Groups
Goals of the CTSU
Provide a wide choice of clinical
trial options to the largest possible number of investigators
Involve a larger number of
treating institutions in the clinical trials process
Increase enrollment to cancer
clinical trials
Streamline or eliminate redundant
processes and procedures
Provide all necessary support
services to make working with the CTSU a positive experience
Protocols on the CTSU Menu
Protocols on the CTSU Menu
Developed
by the adult cancer Cooperative Groups and other research organizations
Includes
nearly all Phase III treatment trials in breast, gastrointestinal,
genitourinary, lung cancers, as well as adult leukemia
Clinical
trials are also offered for gynecological, sarcoma, pancreatic, and other
cancer diagnoses
Protocol Sponsors
Participation in the CTSU
Participation in the CTSU
Participation is open for members
and affiliates of the Cooperative Groups:
*ACOSOG
*CALGB * NCIC CTG * ECOG *
NSABP * GOG
* RTOG * NCCTG
* SWOG
Non-Group aligned sites and
investigators may participate as a CTSU Independent Clinical Research Site
(CICRS)
CTSU Independent
Clinical Research Sites (CICRS)
Before non-Group associated
physicians can enroll patients, they must meet standards similar to those for
Cooperative Group members:
-Credentials must be verified
-Site preparedness must be assessed
Once qualified by the CICRS Review
Committee and contracted with the CTSU they will operate within the CTSU
similar to Group members
The CICRS Program is opened to new
applicants when requested by NCI (the program is currently closed).
Qualification Process for CICRS
Find more information about the
CICRS Program by going to www.ctsu.org
Click on Non-Group Investigators
tab
A notice will state whether the
program is currently open to new applications.
A number of resource documents are
available for interested parties.
An application will be posted
during times when the program is open to applications.
CTSU Membership
Membership
Registration is facilitated by the Cancer Therapy Evaluation Program-Account
Management System (CTEP-AMS)
Still
required for all Group investigators who treat patients or prescribe
medications
Now
required for all others at site who need access to protocol documents,
forms, and educational documents
Purpose of CTEP-AMS
To
provide a central validation of all staff involved in the conduct of
CTEP-sponsored trials
To
facilitate identification of personnel found on multiple Group rosters
To
provide future access to other CTEP databases and programs
To
track/support regulatory compliance for Group Administrators and CTSU
regulatory staff
Requirements of CTEP-AMS Users
Web access
A unique, active e-mail address
for each user
On an annual basis
Associates renew registration and
confirm contact information
As-needed updates to contact
information
Steps to CTEP-AMS Registration
Register
online: www.ctsu.org
Click
on the links entitled:
Register with the CTSU
CTEP-AMS registration system
New Registration
Complete
the appropriate online registration form by clicking Yes or No to the
question, Are you a physician? and by filling in the requested information
Await
e-mail to confirm user name and password
Membership Activation of Investigators
A
CTSU investigator must be an active member in the NCI-CTEP Database and on at
least one Group treatment roster (or be a CICRS participant) in order for
membership to be activated
The
CTSU verifies the physicians credentials with the NCI and Cooperative Group(s)
NCI-CTEP
and Group databases are dynamic. Therefore, these credentials are also
verified at site registration and patient enrollment
Accessing Protocols and Documents
Obtaining Access to CTSU Protocols
Go
to http://members.ctsu.org
Enter
your username and
password
Click
on Protocol tab
Search
for protocols by cancer type, protocol ID, or key word
Select Specific Documents
and Forms from Member Web Site
For each protocol of interest,
download:
Protocol in full text
Amendments
Safety updates
CRFs
AE Forms
Education and promotion materials
Submit Protocols to Local IRB
Begin
this process immediately, based on protocol interest
Submit
protocol, consent forms, and any patient education materials for local IRB
approval
Use
IRB Site Registration Template as a time-saving tool
Not a required form for CTSU
Contains pre-prepared answers to
most common questions posed by IRBs
Prepared for each protocol on the
CTSU menu
Regulatory Document Submission into the
Regulatory Support System (RSS)
Required
before patient enrollment
Sites
are encouraged to submit site registration forms to the CTSU immediately
after local IRB approval is obtained
Avoid
sending protocol-specific regulatory documents at the same time as patient
registration documents, as this will delay patient enrollment
Regulatory Support System
Regulatory Support System
Submitting Regulatory Documents
CTSU
Central Regulatory Office
1818
Market Street, Suite 1100
Philadelphia,
PA 19103
Preferred
method:
Fax:
215-569-0206
The Following Documents Must Be
Submitted
CTSU
IRB Certification Form*
CTSU
Regulatory Approval Transmittal Sheet*
IRB
approved consent forms (when required by the lead Group)
Protocol-specific
regulatory documents (as stated in each protocol)
*all forms are available on the CTSU web
site
CTSU IRB/Regulatory Approval Transmittal Sheet
Required
form when submitting regulatory documents for Phase I-III adult trials
Serves
as a fax cover sheet
Ensures
that each regulatory packet is received at the CTSU in its entirety
CTSU
IRB/Regulatory Approval Transmittal Sheet
CTSU IRB Certification Form
Standardized
form that captures all data elements required for entry into RSS
A
total of 20 required data elements
1-8 may be completed by the site
9-20 must be completed by the IRB
Responsibility of Sites
1. Protocol Number
2. Protocol Version Date
(required for amendments)
3. Protocol Title
4. Institution Name (s)
5. NCI Institution Code
6. OHRP Assurance Number
7. Principal Investigator
8. NCI Investigator #
Responsibility of IRB
Review Type (original, amendment, renewal)
10. Approval Type (full,
expedited, facilitated)
11. Date of Local IRB
Review
12. IRB Number
13. Expiration Date
14. Comments
15 - 20. Signature of IRB
official and contact information
IRB Certification Form
Timeframe for Regulatory Document Submission
Allow 3 business days for
regulatory documents to be processed in RSS before checking status on CTSU web
site
The status can be checked on the
Members web site (http://members.ctsu.org/) under the RSS tab. The user can choose to look up
RSS Site Registration Status or RSS Site IRB Expiration Status
Sites should contact CTSU Help
Desk if a patient enrollment is imminent
Detailed Regulatory Information may be
Found at the Following URLs:
RSS
Frequently Asked Questions:
Enrolling Patients on CTSU Protocols
Ready to Enroll a Patient?
Required
components prior to patient enrollment:
Enrolling physician must be
registered and credentialed with the CTSU
All required Site Registration
materials must be received and approved by the CTSU
Patient informed consent must be
obtained
All protocol-specific pretreatment
evaluations must be performed
Eligibility criteria must be
satisfied
Enrollment Procedure
FAX
the Patient Enrollment Transmittal Form and protocol-specific enrollment
forms (Eligibility Checklist and Registration Form) to the CTSU at
1-888-691-8039
The
CTSU Registrar Office is open Monday Friday from 9am 5:30pm.
Enrollment Procedure
CTSU Patient Registrars will:
Confirm the regulatory
requirements are met
Verify completeness of faxed
enrollment forms
Contact sponsoring Group to
register the patient
Obtain Patient Identification
Number and randomization assignment
Convey patient ID# and
randomization assignment to site
For patient enrollments that must
be completed within approximately 1 hour, please call the CTSU Cell Phone:
301-704-2376
Please use 1-888-462-3009 for ALL
other CTSU enrollment-related matters
Protocol Implementation
Sites
should contact the CTSU Help Desk via telephone or e-mail with questions
CTSU Help
Desk Phone: 1-888-823-5923
Email:
CTSUContact@westat.com
Protocol-specific
eligibility or treatment questions can be submitted to the Study Chair or Group
Operations Office as directed in the protocol
Reimbursement for Participation
Financial Reimbursement for
Group Members*
In
most cases, $2,000 per patient enrollment
Additional
$250 for protocols with a cancer control component
Funds
are dispersed from the CTSU to the credited Group (or directly to the site if
in the CICRS Program)
The
Group will disperse funds to the clinical site
*See following pages for exceptions
based on CCOP sites
Credits for Community Clinical Oncology
Program (CCOP) Members
1
funding/treatment credit for every patient enrollment
Additional
partial credit for trials with a cancer control component
Funded
through the Division of Cancer Prevention (DCP)
The
CTSU will notify DCP of CCOP enrollments on a quarterly basis
Submitting Data through the CTSU
Submitting Clinical Trial Data
Instructions are always specified
in protocol
For the majority of studies, data
forms (CRFs) are to be submitted to the Group leading the trial, using the
methods outlined in the CTSU Logistical Appendix of each protocol document.
The following studies are
exceptions, and data should be submitted to the CTSU according to the protocol
document:
NCIC MA.27 and BR.19, ECOG
PACCT-1, NCCTG N0147, and ACOSOG Z1031
Special Materials Submission
Some
protocols require collection of special materials
tumor blocks
slides
copies of X-ray films
Read
the protocol and send materials as instructed
Handling Data Queries
Queries:
are usually generated by
and sent to sites by the Lead Group.
Query
responses should be submitted back to the Lead Group in the manner specified in
the query letter or protocol document.
Adverse Event (AE) Reporting
Must comply with NCI and U.S. Food
and Drug Administration guidelines
Toxicities are assessed in
accordance with NCI Common Toxicity Criteria (CTC) or NCI Common Terminology
Criteria for Adverse Events (CTCAE)
Guidelines are available by
clicking on the Adverse Events tab of the CTSU Registered Member Web Site
Method and timing of report
collection and dissemination varies across Groups
Follow instructions as indicated
in the protocol
Auditing of Sites in the CTSU
Audits
Will
conduct audits of CTSU patients as part of Cooperative Group audits
Incorporated
into the current audit process by
-CTSU staff augmenting the audit team (if 3
or more enrolled patients)
-Group auditors conduct audit, provided with
protocol-specific materials (if less than 3 enrolled patients)
Follows
guidelines of the Clinical Trials Monitoring Branch (CTMB) of NCI
Education and Promotion
Online information about CTSU
procedures:
»
CTSU Process Checklist
(also available on the public web site)
»
eCOURSE
(also available on the public web site)
Education and Promotion
Online protocol-specific
materials:
Protocol Card
assists with screening
Time and Events
gives overview of protocol events
PowerPoint Presentations
help train research staff
Physician Fact Sheet
offers a summary of treatment plan and patient population with schema on the
back, for each protocol
Obtaining Help
Contact the CTSU
CTSU Help Desk: 1-888-823-5923
Business hours: Monday - Friday,
9am 5:30pm, EST
Phones are answered directly
When phone lines are busy and on
weekends and holidays, voice mailbox is available
Message boxes are monitored hourly
during business hours.
Initial responses to messages made
within 2 hours
Resources