Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Data Reporting and Recording01:24

Data Reporting and Recording

4.6K
Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
4.6K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

[Neurofilament light chain as a tool for assessing disease activity and treatment response in Multiple Sclerosis].

Fortschritte der Neurologie-Psychiatrie·2026
Same author

Feasibility of a registry-integrated eHealth program for managing fatigue and cognitive problems in multiple sclerosis.

Multiple sclerosis journal - experimental, translational and clinical·2026
Same author

Neurofilament Light Chain in Cerebrospinal Fluid and Blood Identifies Patients With Minimal and Overt Hepatic Encephalopathy.

Liver international : official journal of the International Association for the Study of the Liver·2026
Same author

Application of serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (sGFAP) as biomarkers in the clinical management of multiple sclerosis (NeuroFilMS): a protocol for an observational cohort study.

BMJ open·2026
Same author

Assessing Progression Independent of Relapse Activity in Multiple Sclerosis Using a Patient-Reported Disability Measure and Self-Administered Neuroperformance Outcomes.

Annals of neurology·2026
Same author

Diagnostic Value of Neurofilament Light Chain and Glial Fibrillary Acidic Protein in Differentiating Primary From Serious Secondary Headache.

European journal of neurology·2026

Related Experiment Video

Updated: Jun 9, 2025

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
10:46

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data

Published on: December 9, 2015

10.7K

Harmonized Data Quality Indicators Maintain Data Quality in Long-Term Safety Studies Using Multiple Sclerosis

Jan Hillert1, Helmut Butzkueven2,3, Melinda Magyari4

  • 1Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

Clinical Epidemiology
|October 22, 2024
PubMed
Summary

This study applied data quality indicators (DQIs) to assess the reliability of multiple sclerosis (MS) registry data for safety studies. The findings demonstrate DQIs effectively track data quality for regulatory decision-making.

Keywords:
cladribine tabletsfingolimodmultiple sclerosissafety

More Related Videos

The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
11:35

The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool

Published on: June 30, 2014

57.9K
Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla
08:51

Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla

Published on: February 19, 2021

8.9K

Related Experiment Videos

Last Updated: Jun 9, 2025

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
10:46

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data

Published on: December 9, 2015

10.7K
The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
11:35

The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool

Published on: June 30, 2014

57.9K
Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla
08:51

Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla

Published on: February 19, 2021

8.9K

Area of Science:

  • Pharmacovigilance
  • Epidemiology
  • Data Science

Background:

  • Registry-based studies are crucial for assessing long-term safety of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in real-world clinical practice.
  • Data quality variability across registries presents challenges for regulatory decision-making.
  • The CLARION study addresses this by evaluating data quality indicators (DQIs) in a non-interventional safety study of cladribine tablets.

Purpose of the Study:

  • To describe the application of key data quality indicators (DQIs) within the CLARION study.
  • To evaluate the quality of post-authorization safety data from MS registries/data sources over time.
  • To ensure data fit for regulatory decision-making, adhering to EMA guidelines.

Main Methods:

  • Defined 28 DQIs with participating MS registries/data sources based on the EMA Data Quality Framework.
  • Assessed data quality for consistency, accuracy, completeness, and representativeness.
  • Summarized DQIs overall and per registry/source up to November 1, 2022.

Main Results:

  • Analyzed data from 5069 patients across 8 MS registries/data sources in 14 countries.
  • Representativeness DQIs indicated a predominantly female cohort (72.0%) with relapsing-remitting MS (93.5%).
  • Consistency DQIs revealed 6.9% of patients lacked recorded visits within a 2-year follow-up; 3.8% were lost to follow-up. Improvements were noted in recording dates of MS onset and diagnosis.

Conclusions:

  • The application of 28 DQIs in the CLARION study effectively tracked data quality.
  • This process identified determinants of data quality and ensured the reliability of post-authorization safety data.
  • The study provides a robust foundation for regulatory decision-making regarding MS therapies.