Concept↦Management↦Resources↦Study Staff
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:
- 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
What do I need to do?
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.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
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