PSV/SIV
What do PSV and SIV stand for?
Pre-Site Visit, Site Initiation Visit
What is a DOA and what is it used for?
The delegation of authority log is a comprehensive list of the team members outlining specific tasks, accurate start dates, accurate end dates, trained for the appropriate tasks and finally the PI’s oversight acknowledging the appropriate tasks.
Who is responsible for making sure documents are uploaded and maintained in Florence?
The Study Coordinator and/or the Regulatory team (SOP 506 Essential Document Management)
Name 5 things you should do daily to manage your studies/site
Check queries, ECG portal, Laboratory portal, Check for future appointments, Check Open Encounters, Check temperature monitors, etc.
What are 3 things you should do before conducting a PSV?
Schedule a PSV prep call, review the protocol and have questions ready, Locate and re-fill your PSV Summary Form, Have your CV and training certificates readily available, Prep site/PI for the call, etc.
What do you need to back-up delegated tasks for staff on the DOA?
Training certificates, medical licenses, and PI approval
How often should temperature logs be uploaded to Florence?
Monthly
How often should you check for queries in your EDC?
Daily
Who should attend the SIV?
All staff that plan to be on the DOA/help conduct the study
How often should you check your DOA for accuracy or needed updates?
Bi-weekly/as needed when staff changes
Where can you find recruitment material for your study in Florence?
In the study-specific folder, under "IRB Approved Recruitment and Subject Materials"
When should information be entered into IntELLIGO?
Immediately in real-time!
What will you send out after a PSV or SIV?
PSV summary form
SIV summary form
Your study Sub-Investigator did not attend the SIV. Can they be added to the DOA?
No! Not until they've completed a make-up SIV or completed the appropriate protocol training.
What four things should you do on your packing slips before uploading them to Florence?
Check off contents as you make sure they're correct, write "Received," sign and date!
What is a Certified Copy?
A copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all the same attributes and information as the original. (SOP 509)
True/False
Should you have a list of patients from your database during a PSV?
True
You look at your site DOA and notice that ECG administration is not a task listed in the legend at the bottom, but it is required for your study. You should:
A: Call your CRA and ask them to add it or clarify
B: Add it yourself
C: Don't do anything, it's probably included in one of the other tasks in the legend
B. Add it yourself!!
Where do you find old versions of documents in Florence?
On the document, under the "Versions" drop-down
How long after uploading documents as certified copies in Florence or IntELLIGO do you need to keep the paper copy before destroying it?
2 weeks (Per SOP. 509)