Kendle Implementation of CDASH - PhUSE Wiki

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User Acceptance Testing (UAT)• October 2008 – once peer review of our draft eCRFS was completed, wecommenced a full UAT process, undertaken by worldwide Kendle associatesrepresenting:– Clinical Data Management– Clinical Development– Coding– Programming– Statistics• We needed to ensure our standard eCRFS covered the requirements of alldepartments who would directly use them whilst at the same time still adheredto the CDASH standards and so would map easily to SDTM• CDASH version 1.0 was now published – we needed to ensure weincorporated any changes from the draft version20N N o o r r t t h h A A m e e r r i i c c a a •• E u r r o p e • A s i a / P a c i f i c • L a t t i i n A m e e r r i i c c a a • • A A f f r r i c i c a a
Mapping to SDTM and Data Validation Plan
Page 1 and 2: Kendle Implementation of CDASHPhUSE
Page 3 and 4: Formation of CDASH Team
Page 5 and 6: Implementation PrinciplesFullCommun
Page 7 and 8: Theoretical Development ofKendle’
Page 9 and 10: CDASH Form Specification Template (
Page 11 and 12: CDASH Form Specification Template (
Page 13 and 14: Kendle Specification Examples• Co
Page 15 and 16: CDASH Domain: Vital Signs• Date o
Page 17 and 18: Helptext• August 2008 - the CDASH
Page 19: Building and Testing the Draft eCRF
Page 23 and 24: Mapping Specification• AESTM- Con
Page 25 and 26: Status End 2008• December 2008 -
Page 27 and 28: Progress to Date• 2009 - whilst w
Page 29 and 30: Repeating the Rewards
Page 31: Questions?Please contactElke Sennew

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