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Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency

The Original Article was published on 24 May 2022

Correction to: Therapeutic Innovation & Regulatory Science https://doi.org/10.1007/s43441-022-00417-w

In the original article a phrase was omitted from the first paragraph of the Introduction. The corrected paragraph follows:

Good clinical practice (GCP) inspections are conducted by regulatory agencies to assess data integrity and to safeguard the rights, safety, and well-being of study participants as well as to ensure trials are conducted in compliance with GCP and applicable laws and regulations [1–6]. Clinical trials have become increasingly global in the past two decades [7–12]. To address challenges associated with the globalization of clinical trials, FDA and EMA began a GCP collaboration in 2009 to conduct collaborative GCP inspections; conduct periodic information exchanges on GCP-related activities; and share information on interpretation of GCP. This collaboration allowed for a better understanding of each other’s inspection procedures [13]. Over time, this collaboration has expanded to include the regular exchange of inspection related information and the sharing of best inspection practices [14].

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Correspondence to Jenn W. Sellers M.D., Ph.D..

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Sellers, J.W., Mihaescu, C.M., Ayalew, K. et al. Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency. Ther Innov Regul Sci 56, 767 (2022). https://doi.org/10.1007/s43441-022-00427-8

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  • DOI: https://doi.org/10.1007/s43441-022-00427-8