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.
What do I need to do?
- In the event a new site is added to your study
- 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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch