Development↦Management↦Responsibilities↦Site-Investigator
What is it? Why is it important?
The Site-Investigator (Site-INV) has the main responsibility for a particular study-site, where the study of the SP-INV is implemented. Study responsibilities range from set-up until completion, including archiving.
Responsibilities include to:
- Have the required qualifications and relevant expertise
- Provide required infrastructure
- Delegate study tasks to site-staff and ensure staff qualification and training (e.g. documented in a site-delegation log)
- Comply with specifications defined in the study protocol
- Assist the SP-INV with submission to the Ethics Committee (EC)
- Recruit study participants, and obtain their Consent (ICF) to study participation according to IC procedures
- Guarantee participant safety and care (e.g. risk-benefit-ratio)
- Adhere to safety assessment and reporting procedures
- Ensure data quality and confidentiality
- Ensure the correct handling and use of IMP/IMD (e.g. storage, protected access)
- Ensure current and complete document filing in the Site-Investigator-File (ISF)
- Ensure the correct handling and storage of biological material
What do I need to do?
As a Site-INV:
- Familiarize yourself with Site-INV responsibilities
- Retain ongoing oversight of local study activities including any delegated tasks
- Attend GCP training courses for the use of Investigational Medicinal Product (IMP) (e.g. ClinO studies)
- Have ISO 14155 training for the use of Investigational Medical Device (IMD) (e.g. ClinO-MD studies)
- Have ISO 20916 training for the use of in vitro medical device studies
- Exercise the applicable medical profession and have the professional knowledge and scientific expertise for the planned study. In the event a medical profession is not required (e.g. Other Clinical Studies, research projects under the HRO ordinance), exercise the study applicable non-medical profession
Based on your planned study, as a Site-INV you must also comply with:
- The Declaration of Helsinki
- The Declaration of Taipei for the management of a biobank
- Ethics requirements set forth by EC
- Regulatory authorities (e.g. Swissmedic, FOPH, international)
- The Swiss Law and its Ordinances (e.g. ClinO, ClinO-MD)
More
Depending on whether you are a Site-INV or the SP-INV of the study, will greatly affect study obligations and responsibilities.
During study conduct, the Site-INV is responsible to:
- Implement the study according to the current study protocol
- Recruit study participants, explain the conduct and aim of the study and sign the ICF together with the participant
- Ensure that the recruitment of study participants complies with any predefined timelines
- Protect the rights, safety and well-being of study participants (e.g. participant risk-benefit)
- Ensure randomisation procedures are correctly followed
- Guarantee the quality and integrity of study data
- Implement risk control measures
- Forward safety issues to the SP-INV within required timelines
- Handle IMP/IMD according to SP-INV specifications
- Manage study document with ongoing filing of essential documents (e.g. ISF)
- Supervise delegated study-related tasks
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
- Information on professional qualifications
- List of persons conducting a study
References
ICH GCP E6(R2) – see in particular guidelines
- 1.34 Investigator definition
- 4 Site-INV responsibilities
ISO 14155:2020 Medical devices - see in particular sections (access liable to costs)
- 3.30 Investigator definition (Site-INV)
- 3.39 Principal investigator definition (Site-INV)
- 10 Responsibilities of the principal investigator (Site-INV)
Swiss Law
ClinO – see in particular articles
- Art. 2 Definitions
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications