PPI Fundamentals & Definitions
Standardized Calendar & Rules
Variance Commentary & Process
Executive LBE Reports & Process
Clinical Study Data & Process
100
Data produced just-in-time for sequenced senior management meetings to enable better decision-making; Cross-functional commitment to the Calendar allows for compliance with the process for proactive planning and for optimizing resource usage; Process standardization increases operational efficiency.
What are the future state benefits of the implementation of PPI?
100
Places to access the 2010 Monthly LBE Calendar (need at least one right for credit)
What are PWA (current month snapshot) and GPRD Reference eRoom (full 2010 view)?
100
Two variance process activities eliminated from the Monthly LBE process as a result of PPI (must get both).
What are Change Requests and Monthly Variance Meetings?
100
Coordinates the review of variances and topside adjustments at Executive LBE
Who is Finance?
100
Report created on business day (BD) 3 and represents the basis for updating costs for all clinical studies for the remainder of the Monthly LBE cycle.
What is the Clinical Assumptions Report?
200
Provides definitions for terms used in the Monthly LBE process and PBR data
What is the Standardized Dictionary?
200
Monthly LBE cycle business day (BD) that DDPMs have until to make final plan changes in PBR.
What is BD 5?
200
Created as soon as the FGT Upload File is processed.
What are the Functional Variance Files?
200
Two roles responsible for budget processes/reviews of significant financial changes (greater than $1MM annual impact) and will provide reasons for change in expense requirements for program, including overall program progress vs. original targets, at Executive LBE (must get both).
Who are DDPMs and PDs?
200
Venue used to vet any new studies or significant changes for Clinical activities
What is the GPT?
300
Any cost that has been given financial or scientific authorization and has started before the current month - the cost is not completely recoverable should the activity become Not Funded.
What is Committed Cost?
300
Monthly LBE cycle business day (BD) that plan changes must align with IMPACT to be included in current cycle.
What is BD 3?
300
No longer collected at a Financial Project level
What is Variance Commentary?
300
Responsible for budget support of project activities and will be represented at Executive LBE.
Who are the Functions?
300
Role responsible for entering the variance commentary for the Clinical Studies for the Monthly LBE process.
Who are Finance Project Analysts?
400
Statement by DDPMs that summarizes all Functional-level commentary and is appropriate for executive-level managmenet for each PAID that has a variance greater than $250M.
What is the Variance Summary Statement?
400
Monthly LBE cycle business day (BD) when the FGT officially closes for changes (must provide BD and time).
What is BD 10 and 5pm CST?
400
Automation of the Variance Process and collection of Commentary.
What is the soon-to-be-released "Web Variance" tool?
400
Two roles that must incorporate Topside Adjustments into PBR in the next Monthly LBE cycle.
Who are DDPMs and Functions?
400
Two key Clinical Studies dates where PBR and IMPACT are currently aligned (must get both correct!)
What are First Subject Dose (vs. FSI or first patient enrolled) and CSR Approved?
500
Monthly cost variances that occur but are not captured during the current Monthly LBE cycle.
What are Topsite Adjustments?
500
Duration that plans in PBR project plans are now accessible in new Monthly LBE process (provide correct answer in weeks).
What is 2 1/2 weeks?
500
Monthly cost variances that occur but are not captured during the Monthly LBE cycle (e.g. after the close of project plans and/or the FGT).
What are Topside Adjustments?
500
Four components of the Final Executive LBE reporting package (must name all four!)
What are: 1. Executive Externals Variance 2. Milestone Variance 3. Detailed Externals Variance 4. Topside Adjustments
500
Term used in IMPACT for key data available date that is to be aligned to PBR's "Key Data Available".
What is Key Tables Available?
M
e
n
u