Conduct↦Data Handling↦Data Quality↦Adding Stakeholders
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, 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. password protected 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.
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
More
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch