After further discussion with Cancer Therapy and Evaluation Program (CTEP) leadership, we have determined that the deadline to ensure that the Site-Protocol Principal Investigator (PI) is on a participating roster for all sites covered under an IRB approval will be extended to Friday, February 1, 2019.  Please continue to add practice sites to the Site-Protocol PI’s Registration and Credential Repository (RCR) profile, and add the investigator to participating rosters as appropriate.  The CTSU will provide reminders in the CTSU Bi-Monthly Broadcasts and individually reach out to investigators and the primary contacts at affected sites during the next two months.

Of note, the participating roster check for the Site-Protocol PI will not apply to sites outside of the U.S. and Canada.  Sites outside of the U.S. and Canada will need to ensure the Site-Protocol PI listed on the ethics approval maintains an active CTEP registration status, and includes the reviewing ethics board number in the investigator’s RCR profile.

Steps for site staff to take in response to this information:

• Use the Roster Update Management System (RUMS) tab on the CTSU website to see whether your site-protocol PI(s) are on your site roster(s). RUMS will also indicate if any PIs have a suspended CTEP status.

• Know that the CTSU will be sending emails to the PIs and Primary Contacts at any affected sites in both December 2018 and January 2019.  If you do not receive any such emails, you should know that your site is in compliance.  We plan to send emails out on a rotating basis in December and again in January by investigator last name (A-F week 1, G-L week 2, M-R week 3, and S-Z week 4).  As this data may change over time, we hope this catches the majority of investigators that would fail the check as of February 1, 2019.

• Contact the CTSU Help Desk (CTSUContact@Westat.com) to request a report on any affected PIs/studies at your site (please provide as much information as you can in your request, (i.e., site code(s), PI name(s)).

Please note, checks to ensure that the Site-Protocol PI retains an active CTEP status will go into production on December 4, 2018.  Site-Protocol PIs that become suspended will have an end date added to their IRB records, and any approved site registrations will go to a pending status.  For pending or disapproved site registration statuses, an approved site registration status will not be possible until the investigator receives an active CTEP status.