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, from study set-up until completion, including archiving.
Responsibilities include to:
- Have the required study qualifications and 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 given in the study protocol
- Assist the SP-INV in study submission to the Ethics Committee (EC)
- Recruit study participants. Obtain their Informed Consent (ICF) to study participation based on defined IC procedures
- Adhere to safety assessment and reporting procedures
- Ensure ongoing participant safety and care (e.g. risk-benefit-ratio)
- Ensure data quality and confidentiality based on data entry procedures
- Implement the correct handling and use of IMP/IMD (e.g. storage, access protected)
- Ensure current and complete document filing in the Site-Investigator-File (ISF)
- Ensure the correct handling and storage of biological material
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If at a particular site, the study is conducted by a team of individuals, the Site-INV would be the responsible leader of the team. Thus, in these instances the Site-INV will be given the title Principal Investigator.
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)
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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 the recruitment of study participants comply with any predefined timelines
- Protect the rights, safety and well-being of study participants (e.g. participant risk-benefit)
- Ensure study design and randomisation procedures are correctly followed
- Guarantee the quality and integrity of study data collected at the study site
- Follow and ensure risk control measures are implemented and effective
- 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