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16 Cards in this Set
- Front
- Back
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One quality metric at PRA is __ and __ findings following internal or external ___
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Critical
Major audits |
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Another quality metric is the quality of the __ __Documents and PRA generated ___reports. We look at the number of __ occurrences and lack of ___
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Project Planning
status inaccuracy achievement |
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Quality Metric - Number of Database ___ due to DM Issues in ___
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Unlocks
TFLs (tables figures and listings) |
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Quality Metric - Percentage of Successful Data transfers (% per ___ transfers)
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Transfers
total |
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Quality Metric - Percentage of Cumulative Reports (__/___) that have been ___ by Regulatory Authorities
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ASR / PSUR (Annual Safety Report, Periodic Safety Update Report),
rejected |
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Quality metric - Number of Approvals (___ applications). This refers to approval of initial submissions sent to ___
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initial
MOH |
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Quality metric - Number of __ __ rejected
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Essential documents
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Another Quality Metric is __ __ approval and looks at the ___ until finalized. The goal is __% completed within __ days
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trip report
days 95% 14 |
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Another quality metric - want site issues to be identified and __ within __ monitoring visits. Looks at no. of issues that remain __ for more than two monitoring visits
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resolved
2 outstanding |
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PRA's Quality Management System is ___ and is our ___ quality management system
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PRAMS
proprietary |
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PRAMS serves as a company-wide electronic clearinghouse for all PRA ___, ___,___ ___ etc
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SOPs, policies
job descriptions |
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PRAMS is a powerful way of organizing and managing ___, and drives all __ __ tasks. Inputs control how we ___ our work and outputs become the ___ we provide to our clients.
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deliverables
project management perform deliverables |
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Every PRA process also has a corresponding method for ___, so we can assess whether our processes are performing as expected.
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measurement
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our processes include measurement of performance at the ___-level, which are discussed with senior management each month in __ __ __ meetings.
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project
Project Risk Review |
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PRA is a ___-driven company, as evidenced by our membership to the __ ___Consortium.
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metrics
Metrics Champion |
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We review study metrics on a weekly and/or monthly basis and compare them to the ___ agreed deliverables at various points in time during the project life.
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contractually
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