What is it? Why is it important?
Study oversight states that both SP-INV and a Site-INV are responsible to maintain ongoing study supervision during study set-up, conduct, and completion.
Study oversight includes but is not limited to:
- Study progression with respect to expected milestones, mainly linked to participant recruitment during study conduct
- Ongoing qualification and training of current study staff, especially with respect to delegated responsibilities
- Adherence to study QMS and its risk control measures
- Ongoing budgetary control
- IMP/MD handling
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).
What do I need to do?
Define study milestones including required timeline needed for milestones to be carried out.
Milestones could be:
- Study submission to EC/RA
- Study initiation and training
- Attainment of expected participant recruitment numbers
- Last patient last visit
- Study closure and data analysis
In order to maintain ongoing study oversight, schedule regular team meetings with study staff and other relevant parties. Document meetings and keep track of open issues.
It is essential to schedule regular meetings with the study team as it provides opportunity to discuss:
- Study participant recruitment problems
- Risk review and potential adaptation of 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
Meetings can also be used as a platform where staff can be trained on QMS aspects or 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.
To organize Site-INV meeting(s) can be highly time and task efficient, as it:
- Improves site coordination
- Ensures all investigators have received the same information
- Allows for questions & answers affecting all sites
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
Swissethics – in particular see
- Template: Staff List
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)