There’s no I in Team
True or False: If the Type of Approval field in a CCTG approval notification includes language stating “and Informed Consent” then the applicable Informed Consent PSR should not be updated since an IC was not submitted to the CTSU.
False (WP19)
The NRG-GY018 Pharmacy Agreement should be submitted by sites via what?
The DTL
Name the 3 CTSU Teams
Local Team, CIRB Team, Pharma Team
If a site has a pending patient enrollment and they are pending due to a suspended PI, we should confirm the patient’s eligibility and request the site do what actions?
PI re-register with RCR and notify the RCR helpdesk it’s urgent. Or the site can submit a PI change. (Mar 21)
How many sub-tabs are available under the Regulatory Tab?
5
Which office is responsible for collecting and reviewing Health Canada requirements for COG Canadian sites?
COG SMO (WP19)
If a GY018 Pharmacy Agreement is received in error, specialist will perform what steps?
Index as a person attribute and send to AQ_DTL_Training Queue
Who is the CTSU Assistant Project Director?
Erin Mendelsohn
As of March 2021, do automatic PSRs automatically update for closed studies?
Yes (Mar 21)
Protocol Updates, CIRB Updates, LPO Updates among others are located under which tab on the CTSU website?
Protocols
All SSW approvals are pushed from IRB Manager to the CIRB Approval Processing Screen as what type of event?
New Site Event
True or False: The CTSU will apply an annual review or PI Change upon request to the ALLIANCE_COVID_MASTER study.
False
The CTSU Project is a service of the NCI and was originally established in what year?
1999 (per CTSU Project Overview on our website)
When do specialists perform SFU after processing a PI Change approval?
If the study has PI related PSRs on file (Feb 21)
Who is responsible for altering CIRB site preferences on the CTSU website?
Reg Office
All CTSU Patient Transfer Forms are routed to which queue for processing?
AQ_OPEN
The CTSU Operation’s Office is collecting paper CRFs for RTOG-0834. If we receive an RTOG-0834 paper CRF in error we should perform what step(s)?
Courtesy email (INVALID_PAPER_CRF) to site since we cannot select the submission/correct object type
Which 2 shared Regulatory Office email addresses are for CTSU Stakeholder communication only (not for sites)?
CTSURegOffice and CTSURegSetup
We should direct sites where if they contact us regarding a site name change request?
LPO (Jan 21)
The CTSU website uses a Single Sign-On (SSO). Name another databases can we access with the CTEP issued SSO?
RSS, CTEP IAM, OPEN, Rave, Triad, LPO websites
What processing steps should be taken when lab normals for a CITN/PED-CITN studies are received in the RSS?
Which PSRs are we able to accept from the site for 10323 – Moonshot?
None
Who is the CTSU Deputy Program Manager?
Martha Hering
True or False: We should put the CTSUContact email is the CC line only when in our email correspondence.
False (Oct 20)
What should Patient Transfer Forms be submitted as via the Regulatory Submission Portal (RSP)?
Enrollment/Transfer