What is it? Why is it important?
Staff needed for study planning and conduct is different from staff requirements used to run a clinic.
Depending on study design and complexity:
- Additional study management expertise and know-how are required
- Investment in trainings and further education of existing staff is needed
- Additional infrastructure able to accommodate study staff must be organized
- In the event of outsourced services, qualified partners must be evaluated and recruited
Additional study staff needed for your study might include a:
- Project manager who maintains ongoing study oversight and communication with involved parties
- Data manager who sets up the study database and defines the data management plan
- Statistician who calculates the required study sample size and defines the statistical analysis plan
- Monitor who controls study protocol compliance, safety management, and quality and completeness of study data
- Study coordinator/nurse responsible for the management of study participants and the coordination of study visits
- Site-INV responsible for study oversight at a given study site including the delegation of applicable study tasks
What do I need to do?
As a Sp-INV, evaluate staff resources based on:
- Availability: Does staff have sufficient disposable free time to invest in study tasks?
- Know-how: Does staff have the required qualification based on education, training, and experience?
- Feasibility: What resources are not covered and must be outsourced?
Remember to adapt the budget according to additionally required staff and its management. This includes potential outsourced services (e.g. partners).
When planning a study, various fields of expertise are required, such as:
- Specialist physician in the role as SP-INV
- Site-INV responsible for a study site
- Study nurse or study coordinator
- Project manager
- Data manager
- Quality manager
- Regulatory manager
- Laboratory manager
- Monitor or auditor
Depending on study type (e.g. ClinO, ClinO-MD, Other clinical studies, HRO) and activities involved (e.g. study design), other players might also be important, such as biobanking experts, lawyers, patient organisations, cohort manager, etc.
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 – see in particular
- Staff List
ICH GCP E6(R2) – see in particular guidelines
- 4 Site-INV qualification
- 4.2 Adequate resources
- 5. SP-INV responsibilities
- 5.6 Site-INV selection
ISO 14155:2020 Medical devices (access liable to costs) – see in particular sections
- 9 Responsibilities of the sponsor (SP-INV)
- 9.2.1 Investigator selection (Site-INV)
- 10 Responsibilities of the principal investigator (Site-INV)
- 10.3 Qualification of investigation site