CTSU Logo
CTSU Logo Home | Contact | FAQ | CTSU Members Site  
CTSU Logo
Patients PagePhysicians PageNon-Group Investigators PageInformation for Canadian SitesRSS PageCTSU eCourseRelated links to the CTSU project and cancer issues.CTSU Registration Process
 RSS Frequently Asked Questions
(Q1) When preparing RSS paperwork, the IRB Certification Form asks for the protocol version date. On the cover sheet of the protocol that I am using, the protocol lists the current date as the "Activation" date. However, on the bottom left corner of the cover sheet, there is a different date that says "NCI version" date. Also, on another protocol, there is a "Version" date as well as an "Update" date. Which date should I put in the on the IRB Certification Form?

(Q2) Will the IRB Certification Form be submitted for all reviewed projects or only for projects that are accruing patients?

(Q3) When submitting yearly renewals, is a consent form submission required?

(Q4) Where can you find the CTSU IRB Transmittal Form in the CTSU web site?

(Q5) How can I find the NCI Institution Code?

(Q6) How can I find the Investigator NCI number?

(Q7) How can I check the registration status of my protocols on-line?

(Q1)When preparing RSS paperwork, the IRB Certification Form asks for the protocol version date. On the cover sheet of the protocol that I am using, the protocol lists the current date as the "Activation" date. However, on the bottom left corner of the cover sheet, there is a different date that says "NCI version date." Also, on another protocol, there is a "Version" date as well as an "Update" date. Which date should I put in the on the IRB Certification Form?

(A1) Please use the NCI version date on the IRB Certification Form.


(Q2) Will the IRB Certification Form be submitted for all reviewed projects or only for projects that are accruing patients?

(A2) Please submit IRB Certification Form for continuing review until all patients on the study are off study treatment. Sites are expected to comply with the Federal regulations for continuing review during the study follow-up period, but the Regulatory Support System (RSS) will not track continuing reviews during study follow-up. Please note that rules for tracking look at the overall study and not just at the patient status at the site level. In some instances, the lead protocol Group will require tracking of continuing review through the follow-up period. This requirement will be clearly outlined by the lead Group and will be conveyed to sites. For additional information on the new centralized regulatory system, please visit the CTSU public web site at www.ctsu.org and click on the "RSS" tab at the top of the home page.

Back to the top of the page

(Q3) When submitting yearly renewals, is a consent form submission required?

(A3) CTSU sites do not need to send consents to the CTSU for annual renewals.


(Q4) Where can you find the CTSU IRB Transmittal Form in the CTSU web site?

(A4) The CTSU IRB Transmittal Form can be found on the CTSU public web site under the ""RSS" tab. The form is also available on the CTSU members' web site on each protocol-specific document list.


(Q5) How can I find the NCI Institution Code?

(A5) Call the CTSU Help Desk at1-888-823-5923.


(Q6) How can I find the Investigator NCI number?

(A6) Call the CTSU Help Desk at 1-888-823-5923.


(Q7) How can I check the registration status of my protocols on-line?

(A7) To check the registration status of your protocols on-line:

  • Log on to the CTSU members web site
  • Click on the Resources Tab
  • Click on the third topic listing labeled RSS & RDC Applications
  • Click on the fourth labeled RSS Site Registration Status
  • Enter the NCI Site Code for the institution
  • Set Protocol Status category to "All"
  • Set Registration Status to "All" (using the drop down menu arrow)
  • Click Go

    Back to the top of the page

    (Version Date: 4/14/04)