Exploring Computerized Systems in Clinical Research
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Questions and Answers

Which type of computerized system has evolved rapidly in the last few years in clinical research?

  • Various wearable devices
  • Electronic patient reported outcomes (ePROs)
  • Electronic case report forms (eCRF)
  • Artificial intelligence (AI) (correct)

    • What is the purpose of providing guidance on the use of computerized systems in clinical trials?

  • To ensure the quality and reliability of trial data
  • To protect the rights and dignity of trial participants
  • To ensure the safety and wellbeing of trial participants
  • All of the above (correct)

    • What will the guideline describe?

  • Neither generally applicable principles nor key concepts
  • Both generally applicable principles and key concepts (correct)
  • Generally applicable principles
  • Key concepts

    • What is the ultimate goal of using computerized systems in clinical research?

    <p>To contribute to a robust decision-making process</p> Signup and view all the answers

    What types of data are reflective of the changes in computerized systems in clinical trials?

    <p>All of the above</p> Signup and view all the answers

    Which of the following is included in the scope of this guideline?

    <p>Electronic medical records</p> Signup and view all the answers

    What is the purpose of the guideline?

    <p>To ensure the accuracy of trial data</p> Signup and view all the answers

    Which of the following is an example of an electronic trial participant data capture device?

    <p>Mobile device</p> Signup and view all the answers

    What type of data can be captured using electronic clinical outcome assessments (eCOAs)?

    <p>Clinical trial outcomes</p> Signup and view all the answers

    Who uses electronic devices to collect data in clinical trials?

    <p>Clinicians</p> Signup and view all the answers

    Which of the following is NOT a use of AI in clinical trials?

    <p>Data validation</p> Signup and view all the answers

    Which regulations are mentioned in the text?

    <p>All of the above</p> Signup and view all the answers

    What should the approach towards computerized systems used in clinical practice be?

    <p>Risk proportionate</p> Signup and view all the answers

    Which guideline is mentioned as a reference for good clinical practice?

    <p>ICH E6 R2</p> Signup and view all the answers

    Will the guideline initially cover requirements to AI beyond the generally applicable expectations to all systems?

    <p>No</p> Signup and view all the answers

    Study Notes

    Computerized Systems in Clinical Research

    • Computerized systems have evolved rapidly in clinical research in recent years.

    Purpose of Guidance on Computerized Systems

    • The purpose of providing guidance on the use of computerized systems is to ensure data quality and integrity in clinical trials.

    Scope of the Guideline

    • The guideline will describe the use of computerized systems in clinical trials, including electronic trial participant data capture devices.
    • The scope of the guideline includes electronic clinical outcome assessments (eCOAs) and other electronic data capture systems.

    Goals of Computerized Systems in Clinical Research

    • The ultimate goal of using computerized systems in clinical research is to improve data quality and integrity.

    Types of Data Reflecting Changes in Computerized Systems

    • Data reflective of changes in computerized systems in clinical trials include electronic health records (EHRs), electronic data capture (EDC) systems, and electronic patient-reported outcomes (ePROs).

    Example of Electronic Data Capture Device

    • An example of an electronic trial participant data capture device is an electronic diary.

    Data Captured using eCOAs

    • Electronic clinical outcome assessments (eCOAs) can capture patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (CliROs).

    Users of Electronic Devices in Clinical Trials

    • Investigators, site personnel, and clinical trial participants use electronic devices to collect data in clinical trials.

    Exclusion of AI Use in Clinical Trials

    • The use of artificial intelligence (AI) in clinical trials does not include data analysis and interpretation.

    Relevant Regulations

    • Relevant regulations governing computerized systems in clinical trials include good clinical practice (GCP) and other applicable regulations.

    Approach to Computerized Systems in Clinical Practice

    • The approach towards computerized systems used in clinical practice should be risk-based, proportional, and flexible.

    Reference Guideline for Good Clinical Practice

    • The International Council for Harmonisation (ICH) guideline E6 is a reference for good clinical practice.

    Initial Coverage of AI Requirements

    • The guideline will not initially cover requirements to AI beyond the generally applicable expectations to all systems.

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    Description

    Test your knowledge on the use of computerised systems in clinical research, including eCRFs, ePROs, wearable devices, and artificial intelligence.

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