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@ARTICLE{Schrimpf:128289,
      author       = {D. Schrimpf$^*$ and M. Haag and L. R. Pilz},
      title        = {{P}ossible combinations of electronic data capture and
                      randomization systems. principles and the realization with
                      {RANDI}2 and {O}pen{C}linica.},
      journal      = {Methods of information in medicine},
      volume       = {53},
      number       = {3},
      issn         = {0026-1270},
      address      = {Stuttgart [u.a.]},
      publisher    = {Schattauer52258},
      reportid     = {DKFZ-2017-04306},
      pages        = {202 - 207},
      year         = {2014},
      abstract     = {Clinical trials (CT) are in a wider sense experiments to
                      prove and establish clinical benefit of treatments. Nowadays
                      electronic data capture systems (EDCS) are used more often
                      bringing a better data management and higher data quality
                      into clinical practice. Also electronic systems for the
                      randomization are used to assign the patients to the
                      treatments.If the mentioned randomization system (RS) and
                      EDCS are used, possibly identical data are collected in
                      both, especially by stratified randomization. This separated
                      data storage may lead to data inconsistency and in general
                      data samples have to be aligned. The article discusses
                      solutions to combine RS and EDCS. In detail one approach is
                      realized and introduced.Different possible settings of
                      combination of EDCS and RS are determined and the pros and
                      cons for each solution are worked out. For the combination
                      of two independent applications the necessary interfaces for
                      the communication are defined. Thereby, existing standards
                      are considered. An example realization is implemented with
                      the help of open-source applications and state-of-the-art
                      software development procedures.Three possibilities of
                      separate usage or combination of EDCS and RS are presented
                      and assessed: i) the complete independent usage of both
                      systems; ii) realization of one system with both functions;
                      and iii) two separate systems, which communicate via defined
                      interfaces. In addition a realization of our preferred
                      approach, the combination of both systems, is introduced
                      using the open source tools RANDI2 and OpenClinica.The
                      advantage of a flexible independent development of EDCS and
                      RS is shown based on the fact that these tool are very
                      different featured. In our opinion the combination of both
                      systems via defined interfaces fulfills the requirements of
                      randomization and electronic data capture and is feasible in
                      practice. In addition, the use of such a setting can reduce
                      the training costs and the error-prone duplicated data
                      entry.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:24514764},
      doi          = {10.3414/ME13-01-0074},
      url          = {https://inrepo02.dkfz.de/record/128289},
}