Clinetics Data Merge Realization ba, dm and pk can develop their platform specific tools independent from each other



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tarix08.08.2018
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Clinetics Data Merge Overview

  • Andreas Schwarzer and Ralf Schaefer-Pregl – Clinical Data Center, Bayer Vital GmbH, Leverkusen


Clinetics Data Merge - General Project Definition





Clinetics Data Merge - Realization

  • BA, DM and PK can develop their platform specific tools independent from each other

  • They have to deliver their data in the agreed format

  • The ‘Data Description Document DDD’ defines harmonized data formats for data transfers between the departments

  • Data are exchanged via a central area on a Unix server

  • Data are delivered in a fixed CSV file format

  • All transferred files are archived

  • Automatic emails generated if transfer was successful or not



Clinetics Data Merge – Data Description Document

  • Definition of data exchange file

    • File type
    • File content
    • Variable Names
    • Linked GMS code list
  • Definitions are implemented as SAS data sets (Translation tables)



Clinetics Data Merge - Process Description 1

  • Bioanalytics (BA) transfers concentration data to the central data exchange area

  • System transfers data files to a locked directory in the study repository of DM

  • After unblinding DM gets access to the locked directory

  • DM takes the analytic data and integrates them into the Clinical Database (match to CRF sampling data)



Clinetics Data Merge - Process Description 2

  • DM creates transfer file to Clinical Pharmacokinetics (PK) and transfers the file to the central exchange area

  • PK picks up the transfer file from the exchange area and performs the PK evaluation

  • PK transfers the results (PK parameter) back to the exchange area

  • DM picks up the PK results and integrates them into the Clinical Database



Clinetics Data Merge - Data Flow



Clinetics Data Merge – Data Exchange Area 1

  • Static directory tree on a UNIX server …/transfer/pk

  • Subdirectories per transfer direction for

    • Transfer files
    • Archiving
  • Processed files are archived in a history directory branch

  • Files are accessible by any department through Samba based network file system



Clinetics Data Merge – Data Exchange Area 2



Clinetics Data Merge - File Structure



Clinetics Data Merge – Features 1

  • Unix based Cronjob checks in predefined time intervals for new delivered files in the transfer area. In case of any findings a transfer process is initiated

  • Data integrity of files is assured by use of ZIP archives

  • Consistency of data and file structure among departments is checked during transfer by SAS programs called by System after start of transfer



Clinetics Data Merge – Features 2

  • Read and Write access is limited to associated departments – premature unblinding based on concentration data is prohibited

  • Automatic email notification is done in case of successful transfer as well as in case of any errors







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