What is it? Why is it important?

In a study, staff qualifications and ensuing responsibilities must be clearly defined and documented.

Staff qualifications and responsibilities can be documented in:

  • A CV (e.g. education / further education, vocational trainings)
  • Training certificates (e.g. GCP, lMP handling, data entry into the study eCRF)
  • A job description, which is an agreement between employee and line manager regarding employee duties and responsibilities
  • A study delegation-log, specifying staff duties and responsibilities within a given study
  • An organigram, where the structural organisation of a study team is depicted, including communication and reporting lines

Depending on study design and complexity additional requirement may apply, such as:

  • Selective expertise and qualifications (e.g. handling of complex machinery)
  • The recruitment of external service providers (e.g. laboratories)
  • The need for extensive staff trainings

What do I need to do?

As a SP-INV or Site-INV, file the following qualifying documents in the TMF and/or ISF of your study:

  • Study staff CVs
  • The study delegation log
  • Study applicable:
    • Training documents (e.g. study protocol, IMP- and sample management, SOPs, WIs)
    • Certificates (e.g. GCP-training, study applicable training certificates such as laboratory training, IMP/MD handling)
  • If applicable, study relevant job descriptions

Ensure CVs, training logs and job descriptions are up-to-date, personally dated and signed.

Staff expertise during study planning and conduct requires both medical and clinical expertise, including know-how regarding the special demands needed for clinical research.

More

Evaluate staff resources based on:

  • Know-how:
    • What type of skills are needed for the planned study?
    • Does staff have the required qualifications based on education, further education, and vocational training?
    • Which qualifications are missing?
    • Can staff be trained or must specific study tasks be outsourced?
  • Availability: Does staff have sufficient disposable free time to acquire required skills and expertise?
  • Budget: How will the requirement for qualified study staff affect the overall study budget (hiring of experts, staff education and trainings)?

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

  • 2.7 Investigator’s Qualifications
  • 4.1.1 Investigator’s Qualifications
  • 4.1.5 List of study staff
  • 5.4.1 and 5.5.1 Sponsor’s Selection
  • 5.3 Medical Expertise
  • 5.6.1 Investigator’s Qualifications
Abbreviations
  • CTU – Clinical Trials Unit
  • CV – Curriculum Vitae
  • eCRF – Electronic Case Report Form
  • GCP –Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISF – Investigator Site File
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Basic ↦ Documents ↦ Staff Documents ↦ Qualifications
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): Basic ↦ Documents ↦ Staff Documents ↦ Qualifications

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