Where do we access the Protocol Documents (Protocol, Investigator Brochure, Consent/Assent) to open a Cooperative Group Study with the Stanford IRB?
CTSU, Protocols, LPO documents
100
Where do you find the National Accrual goal?
CTSU – Home Page under Protocol tab
100
Where do you find Safety Reports for Cooperative Group Studies
CTSU website under Protocol LPO Documents or DMC Minutes from legacy groups
100
What usually needs to accompany deviation reporting?
A CAPA plan
100
What does CTSU stand for?
Cancer Trials Support Unit
200
Once you have all the Protocol Documents for your study who in CCTO do you contact to open a Cooperative Group Study with the Stanford IRB?
Email everything to CCTO-intake
200
What reports are summarized and submitted during in the SU IRB renewal of a protocol?
SAEs, OSRs, deviations
200
Who needs to review and sign the OSR
The PI must review and sign the OSR or OSR spreadsheet
200
What does CAPA stand for?
Corrective Action and Preventative Action
200
Where do you get protocol documents for COG studies?
Not on CTSU but on the COG website
300
What document should a PI have approved by the CIRB before they open a study through the CIRB process?
A PI worksheet approved by the CIRB
300
How often are CIRB protocols reviewed for “continuing review”?
Most are reviewed every 9 months
300
Where does the OSR need to be submitted?
To CCTO Safety after being reviewed by PI
300
Where should a deviation be filed?
In Oncore and in the study patient binder
300
Where do you check to see if an investigator is CTSU Active?
Investigators link in Regulatory tab
400
Who formulates the Stanford CCTO ICF for a CIRB study?
CCTO Regulatory specialist, after request from the CRC through the Intake process.
400
How is CIRB amendment or continuing review handled?
CRC to save following docs in shared drive: CIRB approval letter, corresponding documents, and updated ICF (if changes made) to ccto-regulatory for review.
400
What is the name of the SAE reporting system for Cooperative Group Studies
CTEP-AERS (Adverse Event Reporting System)
400
NCTN advises to NOT file deviations in the ______ of the chart
Front
400
Where do you check whether your CIRB protocol is in compliance?
Protocols in Regulatory tab
500
What are the three CIRB "local context" approvals before a study can open?
Institution, PI, study specific
500
You have 90 days from which date to make official changes for the protocol amendment?
Broadcast date
EXCEPTION: Remember that if a study is suspended pending IRB approval, this should be done ASAP or a patient may be signing an invalid consent
500
Where do you submit an SAE for Cooperative Group Studies?
Online to CTEP-AERS and cc a copy to ccto-safety. Print copy of the report and file in the patient’s chart.
500
Where do we report major deviations for a CIRB study?
To the CIRB and Oncore. UPs must also be copied to the Stanford IRB.