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Basic Methods Handbook for Clinical Orthopaedic Research pp 121–132Cite as

How to Document a Clinical Study and Avoid Common Mistakes in Study Conduct?

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Abstract

Study conduct is an important and sensitive part of a clinical research project. Adequate planning is paramount to avoid mistakes with potential legal or quality-related consequences. Principal investigators should comply with legal requirements to avoid an early discontinuation of the study. Regulatory binders should be available on-site at any time of the study both in case of an audit and to be consulted by the study team if required. All study activities, from patient eligibility check to data collection through informed consent and study visits, should be carefully planned and scheduled in agreement with the study team prior to first patient enrollment. To allow for a high-quality study, which would deserve to be published in a high-ranked journal, a professional preparation is the key to success.

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Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, Centre Hospitalier de Luxembourg—Clinique d’Eich, Luxembourg, Luxembourg

    Caroline Mouton & Romain Seil

  2. Orthopaedic Biotechnology Laboratory, Galeazzi Orthopaedic Institute, Milan, Italy

    Laura De Girolamo

  3. Sports Medicine Research Laboratory, Luxembourg Institute of Health, Luxembourg, Luxembourg

    Daniel Theisen & Romain Seil

Authors
  1. Caroline Mouton
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  2. Laura De Girolamo
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  3. Daniel Theisen
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  4. Romain Seil
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Corresponding author

Correspondence to Caroline Mouton .

Editor information

Editors and Affiliations

  1. UPMC Rooney Sports Complex, University of Pittsburgh, Pittsburgh, PA, USA

    Volker Musahl

  2. Department of Orthopaedics, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden

    Jón Karlsson

  3. Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Laufen und Liestal), Bruderholz, Switzerland

    Michael T. Hirschmann

  4. McMaster University, Hamilton, ON, Canada

    Olufemi R. Ayeni

  5. Hospital for Special Surgery, New York, NY, USA

    Robert G. Marx

  6. Department of Orthopaedic Surgery, NorthShore University HealthSystem, Evanston, IL, USA

    Jason L. Koh

  7. Institute for Medical Science in Sports, Osaka Health Science University, Osaka, Japan

    Norimasa Nakamura

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Mouton, C., De Girolamo, L., Theisen, D., Seil, R. (2019). How to Document a Clinical Study and Avoid Common Mistakes in Study Conduct?. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_14

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  • DOI: https://doi.org/10.1007/978-3-662-58254-1_14

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  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-662-58253-4

  • Online ISBN: 978-3-662-58254-1

  • eBook Packages: MedicineMedicine (R0)

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