What is it? Why is it important?

A Clinical Data Management System (CDMS) is a type of software used to record, structure, summarise and manage all data collected from and about participants during the implementation of a study.

 

In order to guarantee data safety (e.g. infrastructure, access rights), traceability (audit-trail) and confidentiality, the study CDMS should be carefully selected.

 

Selection should be based on applicable requirements such as:

 

An electronic CDMS:

  • Allows for a structured format-controlled data entry system
  • Facilitates data handling such as:
  • Regulates user access control
  • Allocates applicable user rights (e.g. data entry or modification control)
  • Facilitates multi-centre studies
  • Provides tools for study monitoring (eg. source data verification (SDV), queries)
  • Allows for the archiving of data

What do I need to do?

As a SP-INV, make yourself familiar with:

  • Different CDMSs and their ability to accommodate the specific setup and design of your study
  • Regulatory requirements and the ability of the CDMS to manage and fulfil ICH GCP, Ethics (EC), and regulatory demands.

 

In order to ensure regulatory requirements are met, consult a professional data manager for advice when selecting a CDMS. In addition, the set-up and running of a CDMS (e.g. installation, validation, ongoing software updates, server management) requires extensive expertise and knowhow, and is best managed by a qualified data manager.

More

The CDMS used in the study should:

  • Be based on the riks-based QMS implemented by the SP-INV (e.g. SOP regarding CDMS operations)
  • Be able to handle all study specific requirements as described in the study protocol
  • Have limited and regulated access control
  • Ensure the integrity of all study data, including an audit-trail that documents what data was entered at what time point and by whom
  • Be validated by the SP-INV prior to being used in the study

In order to facilitate ongoing data handling during study conduct, select a CDMS that provides an ongoing overview of the current data entry status (e.g. which visits or data entries are complete, which ones are still open or missing).

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 5.5 Trial management, data handling, and record-keeping

Swiss Law

ClinO – see in particular article

  • Art. 45 Data retention requirements

HRO – see in particular article

  • Art. 5 Storage of health-related personal data and biological material
Abbreviations
  • CDMS – Clinical Data Management System
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC - Ethics Committee
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • QMS – Quality Management System
  • SDV – Source Data Verification
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
Basic ↦ Data Management ↦ Study Database ↦ Clinical Data Management System
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Data Management ↦ Study Database ↦ Clinical Data Management System

Please note: the Easy-GCS tool is currently under construction.