Development↦Management↦Study Management↦Oversight
What is it? Why is it important?
By maintaining study oversight, the Site-INV and Site-INV can ensure the quality of study data and the safety of study participants.
The SP-INV and a Site-INV are both responsible for ongoing study oversight during study set-up, conduct, and completion.
Study oversight includes but is not limited to the supervision regarding the:
- Ongoing compliance with the study protocol
- Ongoing staff qualification and training
- Adherence to the study quality requirements (e.g. risk-based Quality Management System and the review of risk-control measures, monitoring plan, data quality)
- Compliance with safety assessment and reporting requirements
- Ongoing budgetary control
- Correct handling of the study:
- Investigational product (IMP/IMD) (e.g. storage, access control)
- Biological material (e.g. sample workflow)
An important oversight aspect is the surveillance of study progress, which are often coupled with expected pre-set milestones.
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Study milestones could be:
- Study submission to the Ethics Committee (EC) and regulatory authorities (e.g. Swissmedic, FOPH, international)
- Study initiation and training
- Attainment of expected participant recruitment numbers
- Last patient last visit
- Study closure and data analysis
- Publication(s)
Administrative and study relevant tasks can be delegated to applicable study staff, such as a project manager. Nevertheless, final responsibility remains at all times with the respective SP-INV or Site-INV(s) at a particular study site.
What do I need to do?
As a SP-INV, maintain ongoing study oversight by planning to review:
- Study monitoring report(s) to ensure outstanding issues are addressed and resolved
- Study quality and risk-control measures are assess regarding ongoing efficacy and applicability. Include checks for the occurrence of novel risks
- The correct handling of the investigational product (IMP/IMD) and the biological material
- The qualification and training of study staff
As a Site-INV, maintain ongoing study oversight by:
- Complying with quality aspects defined by the SP-INV
- Solving outstanding issues observed during site monitoring as efficiently and rapidly as feasible
- Complying with data collection procedures
It is important to schedule regular team meetings with study staff and other relevant parties. This provides the opportunity to discuss and resolve open issues in a timely manner.
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It is essential to schedule regular meetings with the study team as it provides opportunity to discuss:
- Study participant recruitment problems
- Risk reviews and the potential adaptation of risk-control measures
- Organisational issues such as a shortage in resources (e.g. staff, infrastructure, budget)
- Recurrent issues or problems that might trigger a protocol amendment
Document team meetings and keep track of open issues. Team meetings can also be used as a platform for staff trainings (e.g. study SOPs, WIs, protocol amendments, quality aspects, newly delegated responsibilities)
With respect to budgetary means, a study might receive financial support only during a specific time period (e.g. financial support is only covered during a 2-year period). Keeping track of timeline, study activities, and milestones will ensure that the study moves forward as initially planned, and does not extend over the budgeted period.
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 – in particular see
- Template: Staff List
References
ICH GCP E6(R2) – see in particular guidelines
- 4 Site-INV responsibilities
- 5 SP-INV responsibilities
ISO 14155:2020 Medical devices (access liable to costs) - see in particular sections
- 9 Responsibilities of the sponsor (SP-INV)
- 10 Responsibilities of the sponsor investigator (Site-INV)