What is it? Why is it important?

In a study, staff qualification, training and delegated responsibilities must be clearly defined.

All members of a study team must be qualified by education and training prior to:

  • Taking on study related responsibilities
  • Performing study related tasks

Requirements must be documented such as:

  • A site organigram: structural and organisational relationships
  • CV: education, continuous education, job experience
  • Training: GCP/ISO14155, continuous education
  • Previous study experience
  • Delegation Logs: Definition of delegated study responsibilities

More

Staff trainings should be done:

  • By qualified trainer(s) or through self-training
  • On site, by phone or web-based
  • Both at study initiation and during study conduct
  • Prior to performing any training required study delegated task
  • Upon changes of study relevant documents (e.g. study protocol, ICF, SOPs)
  • Upon change of study relevant staff or delegated responsibilities

Upon training, the trainer and trainee date and sign the training log. By signing, the trainee confirms to have read and understood the content of the given training.

What do I need to do?

Select appropriately qualified staff based on:

  • Professional qualifications (e.g. education, experience)
  • Study specific requirements

Establish a staff management folder that includes study staff education and training documents:

  • CVs
  • GCP/ISO14155, continuous education
  • Applicable study SOPs and WIs

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

Document and approve any study delegated tasks to individual study staff.

More

On the training log, always refer to type of document(s), material(s) or other aid(s) used during training, (e.g. include name of document, validation date, and version number).

As documents are subject to ongoing changes, version or release dates are adapted accordingly. Only by including document details, can it be guaranteed that staff received the appropriate training(s).

Required study specific qualifications may include but are not limited to:

  • Project management
  • Study coordination
  • Safety and risk management
  • Statistics and methodology
  • Various medical examination and analysis
  • Handling of data and electronic data capture
  • Handling of biological material and analysis

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – in particular see

  • Information on professional qualifications
  • List of persons conducting a study

References

ICH GCP E6(R2) – see in particular guidelines

  • 4 Site-INV responsibilities
  • 5 SP-INV responsibilities

ISO 14155:2020 Medical devices - see in particular sections (access liable to costs)

  • 9 Responsibilities of the sponsor (SP-INV)
  • 10 Responsibilities of the principal investigator (Site-INV)

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • CV – Curriculum Vitae
  • HRO – Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Development ↦ Management ↦ Responsibilities ↦ Staff Qualification and Training
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): Development ↦ Management ↦ Responsibilities ↦ Staff Qualification and Training

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