Veeva
How long do we wait for Bot to upload the document in Blinded PAS before we can do manual upload?
48 hrs
When the SNOW PTF ticket you are about to work on is happened to be completed by other CSS beforehand, what SNOW ticket status should you use upon closing?
Closed Successful
What do we use for CTMS Support – Billable Task?
04.04.00 - Site Management
PTSC should be able to deliver draft of Meeting Minutes within how many hours from the time of receipt of relevant materials?
a.) within 4 hrs
b.) within 2 Business days
c.) within 24 hrs
d.) within 48-72 hrs
c.) within 24 hrs
It is an eligibility check to ensure that Clinical Investigators are complying with applicable statutes and regulations set forth by their governing regulatory agencies.
Investigator Compliance Check
I was able to locate the TMF Index in the study’s library, and have found 3 documents named as TMF Index. Which one do I select?
a. TMF Index in pdf format, in Approved status, is in the Oldest date version.
b. TMF Index in excel format, in Approved, pending secondary QC status, in the latest date version.
c. TMF Index in excel format, in Approved status, in the latest date version.
d. TMF Index in excel format, in In Progress status, in the latest date version.
c. TMF Index in excel format, in Approved status, in the latest date version.
What are the 2 ways to capture/populate oldest PTF SNOW tickets? Please demonstrate your answers.
(a.) Thru Empty ticket bin, (b.) Exporting report from Open Ticket widgets.
Integration -
Name the 2 downstream Systems where M-CTMS is the source system
Oracle Site (Activate)
EDMS (TI,Veeva)
When access to meeting recording is not yet provided, the status of the ticket should be in?
a.) Work in Progress
b.) Pending ( change scheduled )
c.) Assigned
d.) None of the above
b.) Pending ( change scheduled )
Give an example/scenario that a Compliance Check is needed to be performed.
• When a site is being considered for study participation
• When there is a change in Principal Investgator or Sub-I
• When necessary, as part of maintenance (e.g., quality concerns, Sponsor request etc.)
When uploading documents to the TMF, I’ve noticed that the protocol code in the document versus the protocol code in the metadata are different; what do I do next?
inform DO that a document breach is noted due to incorrect study (difference between doc uploaded and metadata); copy the VV number of the document; move it to obsolete and raise a TMF ticket to request for hard delete
Final RGL Package tickets can be processed by any CSS even if not trained to process RGL documents as long as “Non-RGL documents” is noted in the description of ticket.
True. Because these Non-RGL are regulatory documents that are not part of the RGL review package.
Name the M-CTMS – Available Functions
Study Management
Site Management
Subject Management
PTSC is expected to primarily own and support which of the following type of meetings?
a.) Vendor Meeting
b.) Study Kick Off meeting
c.) Medical Meeting
d.) CRA meeting
d.) CRA meeting
What will you do if there is no stated Purpose of Check in the Compliance Check Report? The purpose is also not stated in the SNOW ticket.
Coordinate/Reply to the requester or PT asking for the purpose of check.
How do you know if a document has a duplicate?
don’t rely solely in duplicate content report. Do manual check of documents by searching the VV library of the project/ TMF viewer. Check details in each document (dates, version numbers, document names, signatures, etc as applicable).
Name the 12 Support Types (listed in SNOW ticket drop down) accommodated by SWAT Team.
PTF Support- PTASC USE ONLY
Final RGL Package- TMF Filing Support
CTMS Support
PDF Batch Document Preparation
TMF QCRI Support
TMF Document Status Support
Synteract TMF Submission Support
Meeting Minute Transcription
Investigator Compliance Check
CV Upload/Reconciliation
Laboratory Normal Ranges (LNR) Transcription
JPN Translation
Name the iMedidata CTMS – People in CTMS
Resources
Contacts
Internal Staff
Members
How should an MOM request be managed per priority?
a.) Low Priority - since it's not an urgent task
b.) High Priority- since we're expected to deliver within 24 hrs after receipt of materials
c.) Medium Priority - since we can always park it and prioritize other tasks
d.) Not a priority
b.) High Priority- since we're expected to deliver within 24 hrs after receipt of materials
(Category – PDF Batch Preparaon)
You received a request through SNOW for PDF Batch. The requester also asked for you to file this in the TMF. You educate the requester to have it sent through PTF Submission. What job aid will you be providing to the requester?
Veeva Vault PTF Submission (End User Job Aid)
Provide a run-through of the VV TMF Submission process.
refer to job aid and ensure all impt aspects are checked. (I can confirm if their answers are correct
Illustrate the "Decision Tree for Tickets with SA-CSS" discussed during the training.
(Non-verbatim answers are acceptable as long as the thoughts is captured)
Name the CTMS Task PTSC Can support.
Adding Organizations
CLs and FULs - Recon /Downloading Missing Visits
Creating/Updating AIs
Global ICF Update
ICF Checklist Recon
PD Add/Edit
Site Contact Updates
Update Site Status
Complete the statement ( as stated in our PTSC Sync Up ):
PTSC member/CSS cannot participate/attend the sponsor calls and does NOT support _______.
a.) CRA Call
b.) Internal project team meeting
c.) Trusted process events meeting
d.) CMA meeting
c.) Trusted process events meeting
Compose an example of an email about ICC done and there was a finding found on one of the PIs.
Present email