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Managing changes during a clinical investigation, Part I.

Maria Donawa1

  • 1Donawa & Associates Ltd., Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it

Medical Device Technology
|October 8, 2003
PubMed
Summary

Clinical investigations require managing changes to devices, manufacturing, and plans. This article details United States regulatory requirements for handling such modifications during investigations.

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Area of Science:

  • Medical Device Regulation
  • Clinical Investigation Management

Background:

  • Clinical investigations may necessitate modifications to devices, manufacturing processes, or protocols.
  • Ensuring regulatory compliance during these changes is critical for study integrity.

Purpose of the Study:

  • To outline United States regulatory requirements for managing changes during clinical investigations.
  • To prepare for a subsequent discussion of European requirements and standard operating procedures.

Main Methods:

  • Review of United States regulations pertaining to clinical investigations.
  • Analysis of requirements for managing changes to investigational devices and plans.

Main Results:

  • Part I details the specific requirements within the United States for implementing and documenting changes.
  • Understanding these requirements is essential for sponsors and investigators.

Conclusions:

  • Adherence to United States regulations is paramount for managing changes in clinical investigations.
  • A robust understanding of these requirements facilitates compliance and ensures patient safety.

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