Your Easy Guide to Clinical Studies

Staff needed for study planning and conduct is different from staff requirements used to run a clinic.

 

Depending on study design:

• 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

 

Potential staff needed for study implementation include a:

• Project manager who supports ongoing study oversight and communication with involved parties
• Data manager who sets up the study database, and writes the data management plan
• Statistician who calculates the study sample size, and writes the statistical analysis plan
• Monitor who monitors protocol compliance, safety management, and data quality and completeness
• Study coordinator/nurse who manages study participants and the coordination of study visits
• Site-INV who is responsible for a participating study site

As a SP-INV and Site-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?

 

As a SP-INV, 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 as a SP-INV, 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
• Statistician
• Monitor or auditor
• Pharmacist

 

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.

External Links

Swissethics – see in particular

• Staff List

References

ICH GCP E6(R2) – see in particular guidelines

• 2.1 Site-INV qualification and trainings
• 2.2 Adequate resources
• 3. SP-INV responsibilities
• 3.7 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