Podcast
Questions and Answers
Which type of computerized system has evolved rapidly in the last few years in clinical research?
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?
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?
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?
What is the ultimate goal of using computerized systems in clinical research?
What types of data are reflective of the changes in computerized systems in clinical trials?
What types of data are reflective of the changes in computerized systems in clinical trials?
Which of the following is included in the scope of this guideline?
Which of the following is included in the scope of this guideline?
What is the purpose of the guideline?
What is the purpose of the guideline?
Which of the following is an example of an electronic trial participant data capture device?
Which of the following is an example of an electronic trial participant data capture device?
What type of data can be captured using electronic clinical outcome assessments (eCOAs)?
What type of data can be captured using electronic clinical outcome assessments (eCOAs)?
Who uses electronic devices to collect data in clinical trials?
Who uses electronic devices to collect data in clinical trials?
Which of the following is NOT a use of AI in clinical trials?
Which of the following is NOT a use of AI in clinical trials?
Which regulations are mentioned in the text?
Which regulations are mentioned in the text?
What should the approach towards computerized systems used in clinical practice be?
What should the approach towards computerized systems used in clinical practice be?
Which guideline is mentioned as a reference for good clinical practice?
Which guideline is mentioned as a reference for good clinical practice?
Will the guideline initially cover requirements to AI beyond the generally applicable expectations to all systems?
Will the guideline initially cover requirements to AI beyond the generally applicable expectations to all systems?
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.
