WHAT
What is the purpose of GD-PVG-0017?
To describe the procedure for notifying the Central Safety Reporting Team of the termination of a study and the process of returning safety reports to Client.
Who sends notification of study closure to the Global lead SS/SRS?
The project manager
After the global lead SRS/SS gets information for the study closure, what happens next?
The SRS/SS downloads the PVG Central Safety Reporting – File Return Notification Form template and sends a fully populated version to the DL PVG Audit & File Return Notification
Blinded and unblended cases CAN be sent back to the client together.
False- you can never send blinded and unblinded cases together back to the client .
Encrypted zip file sent via email, a hard copy file by courier, CD or eTMF transfer can be used for what?
File Return
who is responsible for notifying the Audit and File return team of a study closure?
Global Lead SRS/SS
How long should the Global lead SRS/SS allow for the Audit File return team to complete the request for a study closure?
Minimum of 6 weeks
Local Submissions ARE included in the return.
TRUE. Since the 3rd September 2018 following the Local Safety Reporting process GD-PVG-0044 WE ARE responsible to include all Local Safety Reporting evidence.
To describe the procedure for notifying the Central Safety Reporting Team of the termination of a study and the process of returning safety reports to Client is which guidance document?
GD-PVG-0017
who is responsible for Downloading the PVG Central Safety Reporting – File Return Notification Form template and send a fully populated version to the DL PVG Audit & File Return Notification.
the Global lead SRS/SS
On completion of the File Return, the Audit and File Return team will....
Forward an email to the Global Lead SS/SRS attaching an inventory form of all returned cases and Courier shipments where applicable.
The PVG Manager is responsible for notifying the global lead SRS/SS of a study closure.
FALSE. the project manager notifies the lead SRS/SS
What method can be used for a file return?
any of the following- Encrypted zip file sent via email, hard copy files by courier, via CD or eTMF transfer
who is responsible for Forwarding an email to the Global Lead SS/SRS attaching an inventory form of all returned cases and Courier shipments where applicable?
the Audit and File Return team
After study closeout- if a client hasn't requested hard copies for return... what is the next step?
The Client must confirm by completing the PVG Central Safety Reporting Hard Copy Destruction Inventory Form for the Audit and File Return team to destroy them after 4 weeks of completion date.
If the global lead SRS/SS has been notified of a study closure, the next step for the SRS/SS is to email the Central Safety eTMF SM notifying them.
FALSE. the global lead SRS/SS must Download the PVG Central Safety Reporting – File Return Notification Form template and send a fully populated version to the DL PVG Audit & File Return Notification.
What is the Global lead SRS/SS to do after notification of a study closure?
the Global lead SRS/SS will need to download the PVG Central Safety Reporting – File Return Notification Form template and send a fully populated version to the DL PVG Audit & File Return Notification.
the client will have to confirm closeout by completing the PVG Central Safety Reporting Hard Copy Destruction Inventory Form for the Audit and File Return team will destroy them after 4 weeks of completion date.
Which date marks the beginning of including the Local Submissions in the file return?
September 3, 2018- following the Local Safety Reporting process GD-PVG-0044
the Global lead SRS/SS should allow the Audit and file return team 7 business days to complete the request.
FALSE. the Global lead SRS/SS should only allow a minimum of 6 weeks to complete the request.