Conduct↦Management↦Responsibility and Oversight↦Site-Investigator
What is it? Why is it important?
The Site-INV is responsible to maintain study oversight at all times during study conduct. Ongoing oversight ensures that any delegated study tasks by the Site-INV are correctly executed. The aim is to protect study participants and guarantee the ongoing quality of study data.
Oversight ensures ongoing:
- Study protocol compliance
- Documentation of study participant recruitment status
- Availability of infrastructure and material
- Accurate IMP/MD storage and access
- Presence of qualified and trained study staff
- Adherence to pre-defined study procedures
- Correct execution of study tasks
- Participant safety and medical care
- Quality of study data
- Submission of annual safety reports
More
During study conduct, the Site-INV is responsible to:
- Implement the study according to the current study protocol, GCP and applicable laws
- Recruit participants, provide applicable information and sign the ICF
- Ensure ongoing recruitment of study participant proceeds according to timeline
- Protect the rights, safety and well-being of study participants
- Ensure study design and randomisation procedures are correctly followed
- Guarantee the quality and integrity of study results collected at the study site
- Follow and ensure risk mitigating measures are implemented and effective
- Forward safety issues to the SP-INV within required timelines
- Handle IMP/MD according to SP-INV specifications
- Manage study document with ongoing filing of essential document (e.g. ISF)
- Supervise delegated study-related tasks
The Site-INV can delegate study tasks to applicable staff. However, overall study responsibility remains with the Site-INV.
What do I need to do?
To ensure oversight, plan and execute regular meetings with your study team to discuss:
- Study progress and recruitment
- Evaluation and efficacy of implemented risk procedures
- Resolution of current / recurring issues and problems including improvement measures
- Shift and reassessment of staff responsibilities
- Applicable training of study SOPs, WIs, study relevant processes
- Document management and ISF filing
Document the meeting and decisions taken in an applicable meeting protocol.
During meetings, problems can be identified early on, allowing for the implementation of preventive measures and thus avoid unnecessary delays.
The meeting protocol provides:
- Resolution of pending issues
- Decision regarding study processes and management
- Transparency and reference tool for absentees
- Evidence of study oversight in the event of an inspection by RA
For more information refer to Quality and Risk in this Study Guide.
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
References
ICH GCP E6(R2) – see in particular guidelines
- 4.2.5 Supervision of delegated tasks
- 4.2.6 Qualification of delegated tasks
- 4.5 Protocol compliance
- 4.11 Safety reporting
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 10 Responsibilities of the principle investigator
Swiss Law
ClinO – see in particular article
- Art. 5 Rules of good clinical practice