Your Easy Guide to Clinical Studies

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

 

Stakeholders can be the addition of new study staff members, such as a data manager (DMan), statistician, monitor, or Site-INV responsible for a given study site.

 

Newly added stakeholders should be:

• Delegated study tasks based on personal education, expertise and training (e.g. documented in the study delegation-log)
• Given applicable access rights to the study database (eCRF) (e.g. login and password)
• Given applicable task trainings (e.g. documented in a training-log)

 

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

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 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
• Inform the SP-INV promptly of any leaving site-staff