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Terms in this set (27)
Global Study Manager
Regional Study Coordinator
Study Design Lead
Knowledge Management System
What is the Singapore Region Code?
Statement of Work
Kit Delivery Date
Visit Test Schedule
What is the Shanghai Region Code?
How long does it take for Specimen Collection Guide Creation (English) ?
11 working days after DDD
Specimen Collection Guide
Investigator Order Notification will provide automatic e-mail updates to external requestors to inform them about the status of their order.
Date first kit will be used
Estimated First Subject In
First patient screened to last patient screened
Length of time it takes 1 patient to complete the CLS visits for the study
What is the Geneva Region Code?
Enrollment + study duration
Total Study Duration
Mid-study transfer of information for data reconciliation
Estimated Interim Data Lock Date
Last transfer of study information for data reconciliation
Estimated Final Data Lock Date
What is the Tokyo Region Code?
French, German, Italian, Spanish LatAm, Spanish European, Portuguese, Mandarin Chinese, & Japanese
What are the 8 core languages besides English?
What is the North America Region Code?
11 working days
How long does it take to translate the IM or SCG into another language?
A test that is not required in the protocol but the client thinks a site might want to order at some point in the study.
Pre Approved Add Test
This is any test not included in the CCLS database but is requested by a site to be performed.
This is not included anywhere in the SOW and does require approval from client, unless SOW states "blanket approval."
Non Protocol Add Test (NPAT)
What type of change is 'removing a special note from the manual'
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