Show:
Start Up
PRC/DFG
Monitor Visit
CTSU
Protocol Amendments
100

What are the three phases of start-up?

Under Consideration, IAP1, and IAP2

100

Who fills out the DFG form? 

Clinical Operations; program manager, study coordinators, investigators 

100

Who is responsible for scheduling the monitoring visits? 

Regulatory Quality Specialist and the Activation Specialist  

100

Where do you find the amendments for NCI CIRB studies? 

CTSU (COG if it is a pediatric study)

100

When you receive an amendment, what is the first thing you need to do? 

Fill out an amendment SharePoint form. 

200

What is the main goal of IAP1 for regulatory? 

Draft ICFs! 

200

What do you need to fill out a PRC form?

You need the signed DFG form to complete the PRC form. 


200

What are the different types of monitor visits we conduct at MUSC? 

Pre site visits, site initiation visits, routine monitoring visits, and close out visits. Another visits we conduct is a kick-off meeting, this is specific to MUSC. 

200

What two things are needed in our NCI CIRB consents?

PI information and MUSC boilerplate language 

200

When do you submit a SP amendment form? (Hint: time line) 

Within 24 hours of receiving the notification from the sponsor. 

300

What are the regulatory goals for IAP2? 

Craft the IRB application, get IRB approval and activate the study. 
300

How do you know when the PRC form is due? 

The IAP2 email and the OnCore task list will outline the due date of the PRC form. 


300

How often can sponsors conduct routine monitoring visits? 

The typical procedure is 6-8 weeks between visits, however, it is dependent on the contract and the sponsor SOP. 

300

What are two ways you can discover amendments that need to be processed? 

Going through the CTSU report and checking each study. Use CRISP notifications as well to receive real time updates. 

300

What systems do you need to update with the amendment documents/version dates? 

SPARC, WebDocs, Regulatory Binder, and OnCore 

400

What should you do if a sponsor wants to change our standard MUSC paragraphs in our ICFs? 

Let them know this is required language per our IRB and loop in a manager to back you up in case the sponsor pushes back. 

400

What two documents do you need to attach to the PRC form? 

The signed DFG form and the TRIPs diagram. 

400

What should you do prior to a routine monitoring visit? 

You should look at the previous follow up letter and the confirmation letter the sponsor sent. You should also prepare the regulatory binder so it has all the regulatory documents. 
400

When should an amendment be implemented at our site? 

30 days from the posted date

400

What should task list amendments be named in OnCore? 

AME_CTO#_Amendment Description