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

Caroline Mouton; Laura De Girolamo; Daniel Theisen; Romain Seil

doi:10.1007/978-3-662-58254-1_14

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 proceeding › Chapter › peer-review

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.

Original language	English
Title of host publication	Basic Methods Handbook for Clinical Orthopaedic Research
Subtitle of host publication	A Practical Guide and Case Based Research Approach
Editors	Volker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura
Place of Publication	Berlin, Heidelberg
Publisher	Springer
Pages	121-132
Number of pages	12
ISBN (Electronic)	978-3-662-58254-1
ISBN (Print)	978-3-662-58253-4
DOIs	https://doi.org/10.1007/978-3-662-58254-1_14
Publication status	Published - 2 Feb 2019

Access to Document

10.1007/978-3-662-58254-1_14

Cite this

Mouton, C., De Girolamo, L., Theisen, D., & Seil, R. (2019). How to document a clinical study and avoid common mistakes in study conduct? In V. Musahl, J. Karlsson, M. T. Hirschmann, O. R. Ayeni, R. G. Marx, J. L. Koh, & N. Nakamura (Eds.), Basic Methods Handbook for Clinical Orthopaedic Research: A Practical Guide and Case Based Research Approach (pp. 121-132). Springer. https://doi.org/10.1007/978-3-662-58254-1_14

Mouton, Caroline ; De Girolamo, Laura ; Theisen, Daniel et al. / How to document a clinical study and avoid common mistakes in study conduct?. Basic Methods Handbook for Clinical Orthopaedic Research: A Practical Guide and Case Based Research Approach. editor / Volker Musahl ; Jón Karlsson ; Michael T. Hirschmann ; Olufemi R. Ayeni ; Robert G. Marx ; Jason L. Koh ; Norimasa Nakamura. Berlin, Heidelberg : Springer, 2019. pp. 121-132

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title = "How to document a clinical study and avoid common mistakes in study conduct?",

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.",

author = "Caroline Mouton and {De Girolamo}, Laura and Daniel Theisen and Romain Seil",

year = "2019",

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day = "2",

doi = "10.1007/978-3-662-58254-1_14",

language = "English",

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pages = "121--132",

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booktitle = "Basic Methods Handbook for Clinical Orthopaedic Research",

publisher = "Springer",

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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 V Musahl, J Karlsson, MT Hirschmann, OR Ayeni, RG Marx, JL Koh & N Nakamura (eds), Basic Methods Handbook for Clinical Orthopaedic Research: A Practical Guide and Case Based Research Approach. Springer, Berlin, Heidelberg, pp. 121-132. https://doi.org/10.1007/978-3-662-58254-1_14

How to document a clinical study and avoid common mistakes in study conduct? / Mouton, Caroline; De Girolamo, Laura; Theisen, Daniel et al.
Basic Methods Handbook for Clinical Orthopaedic Research: A Practical Guide and Case Based Research Approach. ed. / Volker Musahl; Jón Karlsson; Michael T. Hirschmann; Olufemi R. Ayeni; Robert G. Marx; Jason L. Koh; Norimasa Nakamura. Berlin, Heidelberg: Springer, 2019. p. 121-132.

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review