Concept↦Data Handling↦Stakeholders↦Site-Investigator
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 EC approved study protocol provided by the SP-INV (e.g. the Site-INV agrees by dating and signing the approved study protocol)
With respect to Data Management (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 entry tasks to qualified and trained local staff (e.g. data handling, data query management)
- Ensures data entered into the study database during study conduct is of high quality
- 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?
As a SP-INV planning a multi-centre study, establish a requirement profile of participating 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 access to target participants able to fulfill the study inclusion criteria
- Can guarantee high quality data and timely data entry into the study database
- Can ensure the confidentiality and safety of study participants during study conduct
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
External Links
Swissethics – see in particular
- Topics/Other Topics/Professional qualifications of the investigator and project leaders of research projects
References
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
Swiss Law
ClinO – see in particular article
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications