What is it? Why is it important?

Staff needed during study planning and conduct is different from 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

More

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 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?

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 budget for additional staff and its management. This includes potential outsourced services.

More

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
  • Statistician
  • Monitor or auditor
  • Pharmacist

Depending on study type and activities involved, 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

External Links

Swissethics – see in particular

  • Staff List

References

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 – see in particular sections (access liable to costs)

  • 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
Abbreviations
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Management ↦ Resources ↦ Study Staff
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Management ↦ Resources ↦ Study Staff

Please note: the Easy-GCS tool is currently under construction.