What is it? Why is it important?
The Site-Investigator (Site-INV) is responsible for the conduct of a study at a particular study site.
The Site-INV implements the study according to a given study protocol.
With respect to DM responsibilities, the Site-INV:
- Provides feedback to the SP-INV regarding the implementation of the study database (eCRF) at the study site
- Delegates data input tasks to qualified and trained local staff (e.g. data handling, data entry, data query management)
- Ensures data confidentiality by informing the SP-INV regarding changes in local staff (e.g. provide database access to new staff responsible for data entry, remove access from staff leaving the study)
What do I need to do?
When planning a multi-centre study consider recruiting competent local Site-INVs who:
- Are able to implement required study procedures (e.g. study design, applicable randomisation procedures)
- Can provide required infrastructure, resources, and disposable free time required for study conduct
- Have access to competent supporting staff (e.g. data input operator, study coordinator)
- Have adequate access to target participants providing needed study data
- Can guarantee correct and timely data entry into the database of the study
- Can ensure the quality and confidentiality of study data
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
Swissethics see in particular
- Information on professional qualifications – Professional qualifications of the investigator and projet leader
ICH GCP E6(R2) – see in particular guidelines
- 1.34 Investigator definition
- 4.0 Investigator qualifications
- 5.5 Trial Management, data handling, and record-keeping
ClinO – see in particular article
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications