| Study Finances & Clarity | Contract Modification | eTMF | Quality Events | Miscellaneous |
|---|---|---|---|---|
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What are Actuals + Forecasting?
The two factors that when added together equal Supported Units.
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What is Scope?
Changes in this require a contract modification (also called an amendment, addendum, change order).
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What are: PPD Support Materials, Veeva System Trainings, PPD Guidance Documents, Client Facing Documents.
The four categories of documents in the eTMF Knowledge Center.
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What is 3 days?
The maximum amount of time allowed to raise a QEI (Quality Event Initiation) once discovered.
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What is: Veeva Clinical - Risk Management - Study Risk Assessments.
The pathway to access RACT in Veeva.
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What are Direct Fees, Passthrough Fees, and Investigator Fees (which are a subset of Passthrough fees).
The three fee/cost types on the budget grid.
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What is a Change Notification Form (CNF)?
This form is used when the PL identifies a need for an EOA (Evidence of Agreement) for out of scope activity before it can be rolled into a contract modification. [The DIM may be responsible for triaging this].
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What is: Knowledge Center, Ask a Process Specialist, consult Veeva Help, submit an IT Ticket.
The escalation pathway for eTMF questions (there are four steps - not necessarily in this order).
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Quality Event is an issue that has already occurred and Study Risk is risk management/proactive identification of possible risks.
The difference between Quality Event & Study Risk.
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What are: CRG Digital SharePoint, the Project SharePoint folder, eTMF (check TOC for specific location).
The three locations in which you may upload completed meeting minutes.
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What is a pass through fee?
Fees that are not directly related to the D&DS services but are a part of the D&DS budget.
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What is Out of Scope Hours (OOS)?
Work hours that can be recouped from the client but that are currently not in the contract to invoice.
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Who is the Document Owner?
This person is the one who creates the document, uploads it to eTMF, and promotes it to "Approved" when ready (after ensuring the initial quality control is completed per SOP and CRG standards).
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What is the Quality Event Triaging Tool (QETT)?
A risk analysis technique that quickly determines the Qualitative Risk Index (QRI) of a quality event.
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What are pending action items, decisions, and discussions.
The three main things captured in meeting minutes.
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What is CIS (Consulting, Innovation, & Strategy) team?
The team that develops a digital strategy on trials awarded to CRG?
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What is a Clarity New Unit Request Form?
If we need additional OOS, the DIM can forecast additional units in Clarity for the PL to see the Unsupported Hours (UH). If we need additional work that is NOT the same as a contracted unit, we complete this form.
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What is Study Level & Site Level?
In the CRG eTMF, Ad hoc events are one-off events and are not pre-planned, which only happen at these two levels.
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What are: Log & document events, determine QRI, Complete investigation and determine root cause (within 45 days), & formulate and action corrective and preventative actions.
The QEI author has four main responsibilities per the Quality Event Management Process.
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What is: Design, Configuration, Testing, UAT, Implementation.
The five steps in the SDLC.
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What is "hard" and "assigned"?
In Clarity, what are the booking/resourcing statuses that the team should be assigned?
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What is Backlog?
The value of anticipated work which is yet to be performed on a study.
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Baseline Finish Date is the projected initial study target timeline/date and is NOT changed. Planned Finish Date is the current target date.
In regards to Milestones, what is the difference between Baseline Finish Date and Planned Finish Date?
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What are: an application not opening on digital device at the site/wrong application pushed to the site causing a device freeze & missing translations prior to launch forced delay in release
Examples of two low impact quality events.
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What are: perform user and site administration, create updates, deactivate user accounts, activate user accounts.
In an enablement model, these are CSS responsibilities.
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