Start Up
What are the three phases of start-up?
Under Consideration, IAP1, and IAP2
Who fills out the DFG form?
Clinical Operations; program manager, study coordinators, investigators
Who is responsible for scheduling the monitoring visits?
Regulatory Quality Specialist and the Activation Specialist
Where do you find the amendments for NCI CIRB studies?
CTSU (COG if it is a pediatric study)
When you receive an amendment, what is the first thing you need to do?
Fill out an amendment SharePoint form.
What is the main goal of IAP1 for regulatory?
Draft ICFs!
What do you need to fill out a PRC form?
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.
What two things are needed in our NCI CIRB consents?
PI information and MUSC boilerplate language
When do you submit a SP amendment form? (Hint: time line)
Within 24 hours of receiving the notification from the sponsor.
What are the regulatory goals for IAP2?
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.
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.
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.
What systems do you need to update with the amendment documents/version dates?
SPARC, WebDocs, Regulatory Binder, and OnCore
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.
What two documents do you need to attach to the PRC form?
The signed DFG form and the TRIPs diagram.
What should you do prior to a routine monitoring visit?
When should an amendment be implemented at our site?
30 days from the posted date
What should task list amendments be named in OnCore?
AME_CTO#_Amendment Description