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:

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An electronic CDMS:

  • Allows for a structured format-controlled data entry system
  • Facilitates data handling such as:
    • Ongoing data quality checks
    • Ability to trace any modified data
    • The export of any data for further use or analysis
  • Regulates user access control
  • Allocates applicable user rights such as selected data entry control or modification control
  • Facilitates multi-centre studies
  • Allows for ongoing backup and the archiving of data

What do I need to do?

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 regulatory demands

Decide to consult professional advice and expertise for the selection and set-up of your study CDMS, including how to ensure that regulatory requirements are met.

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The CDMS used in the study should:

  • Be based on the 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
  • Be able to provide for an ongoing back-up system

In order to facilitate ongoing data handling during study conduct a CDMS that provides an ongoing overview regarding current data entry status should be selected (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

HRA – see in particular article

  • Art. 5 Storage of health-related personal data and biological material

ClinO – see in particular article

  • Art. 45 Data retention requirements
Abbreviations
  • CDMS – Clinical Data Management System
  • CTU – Clinical Trials Unit
  • QMS – Quality Management System
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
Basic ↦ Data Handling ↦ Study Database ↦ Clinical Data Mgmt. System
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Data Handling ↦ Study Database ↦ Clinical Data Mgmt. System

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