What is it? Why is it important?

The selection of a Clinical Data Management System (CDMS) should be based on:

  • The ability to comply with regulatory requirements (e.g. access control, data security (storage, data confidentiality), traceability and change control (audit trail))
  • The ability to satisfy additional study requirements (e.g. mono- versus multi-centre studies, randomised and blinded studies)
  • User-friendlly (e.g. entry guided navigation, data overview regarding missing data, completed data, and validated data)
  • System specifications (e.g. licence costs, provider support, updates and user validation)

The CDMS provides the basis for the set-up of the study database must thus Back-Up and Recoverybe able to comply with the Swiss law, ICH GCP, and the Declaration of Helsinki.

More

Regulatory requirements demand that data protection laws are respected and followed. Thus, a selected CDMS software system should be able to:

  • Allocate personalised logins with selective access means to the study database, such as the ability to define and allocate individual roles and rights (e.g. selective access, data entry, validation, read-only, export)
  • Track entries and changes to the study database. Thus, information on when and what staff was responsible for a given entry or change is documented on ongoing basis (also referred to as an audit-trail)
  • Provide features that facilitate data monitoring processes (e.g. access to central monitoring)
  • Allow database lock or freeze in order to prevent unauthorised changes
  • Allow the data to be stored on a local server 
  • Provide for a reliable back-up and recovery system that prevents data loss

Questions to ask when selecting a CDMS:

  • System set-up:

Does the system perform according to intended use?

  • Installation:

Will the application function as intended in an alternative user environment (e.g. the given network of a local institution)?

  • Application during study conduct:

Is functionality assured with consistent intended performance (e.g. access rights, data entry, audit trail)?

What do I need to do?

Based on the risk and complexity of your study, make yourself familiar with the functionality of various CDMSs.

Consult with experts in order to decide which system best fits the purpose of your study (e.g. data manager, statistician, project manager).

Assess local resources able to set-up and maintain a study database. If applicable, consider out-sourcing some of these services.

The selected CDMS must be certified prior to being used.

More

Satisfying regulatory requirements can be labour intensive, expensive, and requires access to professional expertise.

Questions to ask when selecting a CDMS

  • Does it fulfil regulatory requirements?
  • What specifications must be covered based on the study protocol?
  • Can the system recognise and tag missing and implausible data?
  • Can computed calculations be controlled for accuracy?
  • Where data is stored (e.g. server location)?
  • How are back-up, emergencies (shut-down) managed?
  • How are multi-centre studies accommodated?
  • What are set-up, up-keep, and licence costs?
  • How will risk assessment be managed?
    • What is the likelihood or frequency of an undesired event?
    • The extent to which it can be detected?
    • What would be the expected impact on participant safety and reliability of study results?
  • Do I have blinded data, and does the system prevent accidental unblinding?
  • Can user access to the system be individually granted and removed?
  • Is participant identification protected against accidental disclosure?

Where can I get help?

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

External Links

GCDMP – see in particular

  • Chapter “Vendor selection and management” – Recommendations for evaluating and selecting of vendors

References

ICH GCP E6(R2) – see in particular guidelines

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

Declaration of Helsinki – see in particular principles

  • Nr. 9.0 Personal information of research subjects
  • Nr. 24 Protection of privacy
  • Nr. 36 Publication

Swiss Law

ClinO – see in particular article

  • Art. 5 Rules of Good Clinical Practice

HRO – see in particular article

  • Art. 5 Storage of health-related personal data and biological material
Abbreviations
  • CDMS – Clinical Data Management System
  • CTU – Clinical Trials Unit
  • GCDMP – Good Clinical Data Management Practice Guide
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
Concept ↦ Data Handling ↦ Clinical Data Mgmt. System ↦ Selection
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): Concept ↦ Data Handling ↦ Clinical Data Mgmt. System ↦ Selection

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