What is it? Why is it important?

In the event additional stakeholders are asked to participate in the study, they should be trained on DM procedures prior to performing any delegated tasks.

Added stakeholder might be new staff at an already participating study site or the addition of a totally new study site. Newly added staff should receive access rights (password protected login and password) to the study database (eCRF) with prior documented training.

For new study sites patient recruitment and data entry can start after the successful completion of a site initiation visit.

What do I need to do?

  • In the event a new site is added to your study
    • Initially apply for an approval to add an additional site to your study by submitting an application to EC
    • Ask the DMan to create / add a new site in the study database
  • Train new staff on DM responsibilities (e.g. data entry procedures, data confidentiality, handling of data queries)
  • Inform the DMan to provide staff with individual access rights to the study database (eCRF)
  • Update newly added access rights in the study access log
  • Document DM training in the site training log

Where can I get help?

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

  • CTU – Clinical Trials Unit
  • DM – Data Management
  • DMan – Data Manager
  • EC – Ethics Committee
  • eCRF – Electronic Case Report Form
Conduct ↦ Data Handling ↦ Data Quality ↦ Training

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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

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): Conduct ↦ Data Handling ↦ Data Quality ↦ Training

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