How to document a clinical study and avoid common mistakes in study conduct?

Caroline Mouton*, Laura De Girolamo, Daniel Theisen, Romain Seil

*Corresponding author for this work

    Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


    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.

    Original languageEnglish
    Title of host publicationBasic Methods Handbook for Clinical Orthopaedic Research
    Subtitle of host publicationA Practical Guide and Case Based Research Approach
    EditorsVolker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura
    Place of PublicationBerlin, Heidelberg
    Number of pages12
    ISBN (Electronic)978-3-662-58254-1
    ISBN (Print)978-3-662-58253-4
    Publication statusPublished - 2 Feb 2019


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