What is it? Why is it important?

In the event new stakeholders are asked to participate in a study, they should be trained on Data Management (DM) procedures prior to performing any delegated tasks.


Stakeholder can represent the addition of an additional participating study site, a staff member, data manager, statisticianmonitor, or Site-INV responsible for a given study site.


Newly added stakeholders should be:


For newly added study sites, participant recruitment and data entry can only start after the successful completion of a site initiation visit.

What do I need to do?

As a SP-INV:

  • When adding a new study-site to your study:
    • Seek the approval by submitting an application to EC
    • Upon EC approval, ask the DMan to add the new site to the study database (e.g. ensure data confidentiality by giving sites only access to their own data)
    • Perform a site initiation visit prior to making the eCRF available for data entry
  • Train new study-sites or site-staff on DM responsibilities (e.g. data entry and data quality procedures), and document the delegation of study tasks in a delegation-log
  • Ensure staff members receive individual access rights to the study database (eCRF)
  • Ensure access rights remain current by removing access rights from leaving staff
  • Document DM trainings in a site training-log



As a Site-INV, ensure:

  • The qualification and training of your site-staff
  • Training remains current, based on responsibilities defined the site-delegation-log (e.g. data entry and data quality procedures)
  • Inform the SP-INV promptly of any leaving site-staff

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
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Data Handling ↦ Data Quality ↦ Adding Stakeholders

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Data Handling ↦ Data Quality ↦ Adding Stakeholders

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